Abstract
Introduction: Cardiac implantable electronic devices (CIEDs), including pacemakers, defibrillators, and resynchronization devices, significantly enhance patient outcomes, reduce sudden cardiac death, and improve health-related quality of life. CIED implantation is associated to persistent shoulder dysfunction in a considerable number of patients one-year post-implantation. This may result in disability, diminished quality of life, work absenteeism, and negative psychological effects. Restoring upper extremity function after CIED implantation should be a standard of cardiovascular care. Our systematic scoping review aimed to summarize available evidence, addressing vital questions about safety, effectiveness, exercise type, and time of exercise initiation immediately after CIED implantation. Methods: We conducted a comprehensive literature search in 5 electronic databases for original research in English, and a manual search on the references of included studies. We used Rayyan web application for study selection, and PRISMA-ScR to conduct and report the review. We assessed methodological quality using the Cochrane Risk of Bias Assessment Tool and Joanna Briggs Institute critical appraisal checklists. Results: This review included 6 studies that used upper extremity pendular, range of motion, stretching and strengthening exercises. Initiation time varied from the first postoperative day to the second postoperative week. All studies showed significant association between active upper extremity exercise and reduced dysfunction and disability after CIED implantation. There were no significant differences in complication rates between control and experimental groups. Conclusion: A limited number of low-to-average quality studies suggest active upper extremity exercise immediately after CIED implantation is safe, effective at reducing dysfunction, and improves quality of life. Higher-quality studies are needed to validate these findings.
Introduction
Cardiac implantable electronic devices (CIEDs) have been proven to significantly reduce the incidence of sudden cardiac death [1, 2]. Multiple studies have demonstrated that these devices also reduce morbidity and mortality, while improving cardiac symptoms and health-related quality of life (HRQOL) for patients [3‒5]. The number of patients with CIEDs is increasing due to these proven benefits [6‒8].
Though the insertion of a CIED is regarded as a minor surgery, it is worth noting that it is not exempt from complications. One of the major complications is ipsilateral upper extremity (UE) dysfunction [9]. The most commonly reported types of UE dysfunction are shoulder pain and shoulder joint limitation in range of motion (ROM). Studies that analyzed these UE dysfunctions have revealed the majority of patients still experienced shoulder joint dysfunction 12 months after CIED implantation [9].
The most common factors associated with shoulder dysfunction are the pectoral approach to implantation, immobilization practices, and the dimension of the CIED [9]. The pectoral approach of implantation may cause trigger points in the trapezius and deltoid muscles as well as pain in the pectoralis muscle, which negatively impact shoulder function [10, 11]. Furthermore, if significant injury to the pectoralis muscle occurs during the implantation procedure, the biomechanics of the shoulder may be compromised, leading to shoulder dysfunction [12, 13].
The implementation of shoulder immobilization or mobilization practices after CIED implantation is not consistent. Oftentimes, patients are advised to immobilize the ipsilateral shoulder, using either a sling or an elastic bandage wrap, to restrain arm and shoulder in order to prevent lead displacement [14, 15]. If this immobilization or restriction of arm movement is prolonged, it may lead to the degeneration of the surrounding connective tissues of the shoulder joint, resulting in restricted joint ROM and shoulder dysfunction [16, 17].
Appropriate active ROM is essential to perform all types of Activities of Daily Living (ADL) [18, 19]. Multiple studies show that if UE dysfunctions are left untreated they may lead to considerable disability and poor HRQOL. This may lead to increased absences from work and negatively impact the psychological state of the patient [2, 20]. It is therefore critical to preserve or restore the UE function after the implantation of CIED.
Shoulder exercise programs have proven to be effective to prevent UE dysfunctions [21‒23]. However, the safety and effectiveness of an active shoulder exercise program to restore joint function in patients with recent CIED implantation is not well-defined. There are a wide range of unanswered research questions with regard to the effectiveness, safety, and appropriate initiation time of an exercise program to prevent UE dysfunction after CIED implantation.
We conducted a systematic scoping review to comprehensively summarize the available evidence for UE exercise interventions in patients with recent CIED implantation. To be able to provide directions for further research, we aimed to determine the following:
- 1.
The safety and effectiveness of exercise in preventing UE dysfunction in patients with a CIED.
- 2.
Types of UE exercises prescribed for patients with a CIED.
- 3.
The appropriate time to initiate exercise after CIED implantation.
Methodology
The protocol has been registered with the Research Registry (review registry 1006). We conducted this review according to the framework recommended by Arksey and O′ Malley [24] and Levac [25], and we have reported it in accordance with PRISM extension for scoping reviews (PRISMA-ScR) [26]. The PRISMA-ScR checklist is included as online supplementary material (for all online suppl. material, see https://doi.org/10.1159/000538793). The PCC (Population, Concept, and Context) approach was used to formulate the research questions:
P = Patients with CIED
C = Upper Extremity Exercise
C = Male and female patients in acute care settings
Research Questions
- 1.
What type of UE exercise interventions are prescribed for patients with a CIED?
- 2.
What is the appropriate time to initiate UE exercise interventions for patients with a CIED?
- 3.
How effective are UE exercise interventions in preventing UE dysfunctions in patients with recent CIED implantation?
- 4.
What are the reported adverse events associated with UE intervention for patients with recent CIED implantation?
Search Strategy
A literature search was conducted in the following electronic databases for original research published in English: OVID MEDLINE, OVID Emcare, PubMed, Embase and Cochrane Central Register of Controlled Trials (CENTRAL). The complete search strategy used is presented as online supplementary material 1. Additionally, a manual search was performed on the references to the included studies, which is reported on the PRISMA Flow Diagram as references from other sources in online supplementary material 2.
Study Selection Criteria
Inclusion Criteria
Study designs included randomized control trials (RCTs), clinical trials, cohort studies, cross-sectional studies, case series, and case studies. The studies had to have among their objectives to assess the safety and/or effectiveness of UE exercise in preventing UE dysfunction in patients with recent CIED implantation, and/or the appropriate time to initiate exercise. Only studies published up to October 27, 2023, were included.
Exclusion Criteria
Studies not published in English were excluded.
Study Selection and Data Extraction
The results of the search were imported to Rayyan web application [27]. After removing duplicates, the study selection was conducted in a 2-stage screening process. For stage 1, three reviewers (P.J.S., G.M., and D.K.S.) independently screened all studies (title and abstract) using the predetermined criteria. Studies that analyzed the safety and effectiveness of UE exercises in preventing UE dysfunction in patients with a CIED, and/or studies reporting the appropriate time to initiate exercises in patients with a CIED, were included. For stage 2, three reviewers (P.J., P.J.S., and J.L.D.) independently conducted the full text screening. Disagreements in both stages of screening were resolved by consensus and the involvement of a fourth reviewer (N.S.). The PRISMA flow diagram of this study is presented in online supplementary material 2.
A blinded data extraction and verification process was conducted. Initial data extraction of the included studies was conducted by D.K.S. and G,M. Verification of the initially extracted data was conducted by P.J. and J.L.D. The discrepancies were resolved by the involvement of a fifth reviewer (P.J.S.). The data extraction form included study design, country, the number of participants, type of CIED, type of UE exercises (control group and interventions), time of initiation of UE exercises, outcomes measures, adverse events, and follow-up period. When required, the corresponding author was contacted for clarification.
Analysis of Risk of Bias
This review included four RCTs [11, 28‒30] for which quality assessments were conducted independently by two reviewers (P.J. and P.J.S.). The RCTs were appraised using the Cochrane Risk of Bias (RoB2) Assessment Tool [31] (online suppl. material 3). The case control retrospective study [32] and the prospective cohort study [14] were assessed using the appropriate Joanna Briggs Institute (J.B.I.) critical appraisal checklist by two reviewers (P.J. and P.J.S.) (online suppl. material 4, 5). Disagreements were resolved by a third reviewer (N.S.) and by consensus.
Results
Of the 546 studies retrieved, six studies [11, 14, 28‒30, 32] (four RCTs, one prospective study, and 1 case control retrospective study) met the eligibility criteria and were included in this review. One study [29] examined the effect of UE exercise on prevention of adhesive capsulitis of the ipsilateral shoulder following CIED implantation. Three studies [11, 28, 30] analyzed the impact of various UE exercises on shoulder dysfunction after CIED implantation. Another two studies [14, 32] investigated the safety of early UE exercise following CIED implantation (Tables 1, 2, 3).
Types of exercise interventions used
| Author/year (country) | Type of study | Number of participants | Type of device | Implantation pocket | Exercise interventions reported control versus interventions |
|---|---|---|---|---|---|
| Wongcharoen et al. [28] (2019) (Thailand) | RCT | N = 200, control group (CG) = 99, exercise group (EG) = 101 | Single-chamber PPM, dual-chamber PPM, ICD | Prepectoral pocket, subpectoral pocket | CG: standard care instructions which included ipsilateral arm activity restrictions with no pushing, pulling or movements above the level of the shoulder for 2 weeks after implantation |
| EG: 2 sets of 10 repetitions of pendulum ipsilateral arm movement in a clockwise rotation followed by 10 repetitions in a counterclockwise rotation, twice daily. Arm activity after implantation of device was not restricted | |||||
| Daniels et al. [11] (2011) (USA) | RCT | N = 44, control group (CG) = 21, exercise group (EG) = 23 | PPM, ICD, bi-ventricular ICD | Sub clavicular pocket | CG: standard instruction including no lifting objects heavier than 5–8 pounds and avoidance of raising the ipsilateral elbow above the shoulder level for 6 weeks post-implant, no exercises given |
| EG: exercise included chest stretch clasping hands behind the back. Punches, band pull: elbows bent to 90°, arms against their sides, and palms up. Arm raise: 90 degree shoulder lateral abduction with thumbs pointing the ceiling. Program was completed 3 days per week for 6 weeks. Telephone calls for compliance to exercise program and monitoring the adverse events at weeks 2, 3, 5, and 6 | |||||
| Jorat et al. [29] (2020) (Iran) | RCT | N = 62, group A: 28, group B: 34 | PPM, ICD | Infra-clavicular area, subcutaneous pocket | Group A: passive glenohumeral joint stretch followed by scapular exercise, Codman’s pendular exercises, finger wall climbing exercise, back shoulder circling exercise, and standard home exercise program, 3 times per day |
| Group B: standard home exercise program | |||||
| Cosgun et al. [30] (2022) (Turkey) | RCT | N = 89, control group (CG) = 30, pendular exercise group (PEG) = 31, stretching and strengthening group (SSEG) = 28 | PPM, ICD, CRT-D | Prepectoral subfascial area subcutaneous pocket | CG: no exercise regime, only standard care instructions |
| PEG: 10 repetitions of the ipsilateral arm, first clockwise and then counterclockwise, twice daily | |||||
| SSEG: chest stretch, arm raise, punches, and band pull every other day for 6 weeks | |||||
| Takeda et al. [32] (2023) (Japan) | Single-center case-control retrospective study | N = 591, limitation protocol group (LPG) = 155, stepwise protocol group (SWPG) = 251, early protocol group (EPG) = 185 | PPM, ICD, CRT-D | Subcutaneous implantable | LPG: the range of motion of the shoulder joint adjacent to the CIED should not be more than 90 degrees in flexion and abduction, and to restrict upper extremity usage on the side of the CIED immediately after the implantation until discharge |
| SWPG: on the first postoperative day, shoulder joint on the side of CIED flexion and abduction to 45 degrees. On the second postoperative day, allowed to move shoulder joint of the upper extremity on the side of CIED flexion and abduction within 90 degrees. On the third day, allowed to move the shoulder joint of the upper extremity on the side of the CIED flexion and abduction of 120 degrees. On fourth day, this was increased to 180 degrees On the fifth postoperative day, the patients were told that a protocol of no restrictions on using the upper extremity on the adjacent side of CIED in daily life | |||||
| EPG: the patients were allowed to move intentionally the range of motion of the shoulder joint on the side of the CIED flexion and abduction to 180 degrees from the day after surgery if there was no pain, shoulder joint exercises, daily living exercises, and upper extremity functional exercises on the side of the CIED according to pain from the day after surgery | |||||
| Naffe et al. [14] (2009) (USA) | Single-center prospective study | N = 10 | PPM, ICD | Subcutaneous pocket in the pectoral area | The subjects were asked to sit on their hospital bed, put their feet flat on the floor, and perform four resistive range-of-motion exercises using the arm of the affected shoulder. The subjects were coached on proper technique then led through a warm-up/educational range-of-motion set of 10 repetitions using the following exercises: military press, diagonal raise, overhead triceps extension, and frontal raise. Subjects then performed two sets of 10 repetitions of the same resistive exercises while holding either a 1 or 2 pounds hand weight. The subjects’ ability to tolerate the exercise load determined which weight was used. Exercises were performed to the cadence of 2 s up and 2 s down and were completed within 15 min |
| Author/year (country) | Type of study | Number of participants | Type of device | Implantation pocket | Exercise interventions reported control versus interventions |
|---|---|---|---|---|---|
| Wongcharoen et al. [28] (2019) (Thailand) | RCT | N = 200, control group (CG) = 99, exercise group (EG) = 101 | Single-chamber PPM, dual-chamber PPM, ICD | Prepectoral pocket, subpectoral pocket | CG: standard care instructions which included ipsilateral arm activity restrictions with no pushing, pulling or movements above the level of the shoulder for 2 weeks after implantation |
| EG: 2 sets of 10 repetitions of pendulum ipsilateral arm movement in a clockwise rotation followed by 10 repetitions in a counterclockwise rotation, twice daily. Arm activity after implantation of device was not restricted | |||||
| Daniels et al. [11] (2011) (USA) | RCT | N = 44, control group (CG) = 21, exercise group (EG) = 23 | PPM, ICD, bi-ventricular ICD | Sub clavicular pocket | CG: standard instruction including no lifting objects heavier than 5–8 pounds and avoidance of raising the ipsilateral elbow above the shoulder level for 6 weeks post-implant, no exercises given |
| EG: exercise included chest stretch clasping hands behind the back. Punches, band pull: elbows bent to 90°, arms against their sides, and palms up. Arm raise: 90 degree shoulder lateral abduction with thumbs pointing the ceiling. Program was completed 3 days per week for 6 weeks. Telephone calls for compliance to exercise program and monitoring the adverse events at weeks 2, 3, 5, and 6 | |||||
| Jorat et al. [29] (2020) (Iran) | RCT | N = 62, group A: 28, group B: 34 | PPM, ICD | Infra-clavicular area, subcutaneous pocket | Group A: passive glenohumeral joint stretch followed by scapular exercise, Codman’s pendular exercises, finger wall climbing exercise, back shoulder circling exercise, and standard home exercise program, 3 times per day |
| Group B: standard home exercise program | |||||
| Cosgun et al. [30] (2022) (Turkey) | RCT | N = 89, control group (CG) = 30, pendular exercise group (PEG) = 31, stretching and strengthening group (SSEG) = 28 | PPM, ICD, CRT-D | Prepectoral subfascial area subcutaneous pocket | CG: no exercise regime, only standard care instructions |
| PEG: 10 repetitions of the ipsilateral arm, first clockwise and then counterclockwise, twice daily | |||||
| SSEG: chest stretch, arm raise, punches, and band pull every other day for 6 weeks | |||||
| Takeda et al. [32] (2023) (Japan) | Single-center case-control retrospective study | N = 591, limitation protocol group (LPG) = 155, stepwise protocol group (SWPG) = 251, early protocol group (EPG) = 185 | PPM, ICD, CRT-D | Subcutaneous implantable | LPG: the range of motion of the shoulder joint adjacent to the CIED should not be more than 90 degrees in flexion and abduction, and to restrict upper extremity usage on the side of the CIED immediately after the implantation until discharge |
| SWPG: on the first postoperative day, shoulder joint on the side of CIED flexion and abduction to 45 degrees. On the second postoperative day, allowed to move shoulder joint of the upper extremity on the side of CIED flexion and abduction within 90 degrees. On the third day, allowed to move the shoulder joint of the upper extremity on the side of the CIED flexion and abduction of 120 degrees. On fourth day, this was increased to 180 degrees On the fifth postoperative day, the patients were told that a protocol of no restrictions on using the upper extremity on the adjacent side of CIED in daily life | |||||
| EPG: the patients were allowed to move intentionally the range of motion of the shoulder joint on the side of the CIED flexion and abduction to 180 degrees from the day after surgery if there was no pain, shoulder joint exercises, daily living exercises, and upper extremity functional exercises on the side of the CIED according to pain from the day after surgery | |||||
| Naffe et al. [14] (2009) (USA) | Single-center prospective study | N = 10 | PPM, ICD | Subcutaneous pocket in the pectoral area | The subjects were asked to sit on their hospital bed, put their feet flat on the floor, and perform four resistive range-of-motion exercises using the arm of the affected shoulder. The subjects were coached on proper technique then led through a warm-up/educational range-of-motion set of 10 repetitions using the following exercises: military press, diagonal raise, overhead triceps extension, and frontal raise. Subjects then performed two sets of 10 repetitions of the same resistive exercises while holding either a 1 or 2 pounds hand weight. The subjects’ ability to tolerate the exercise load determined which weight was used. Exercises were performed to the cadence of 2 s up and 2 s down and were completed within 15 min |
CG, control group; CRT-D, cardiac resynchronization therapy defibrillator; EG, exercise group; EPG, early protocol group; ICD, implantable cardioverter-defibrillator; LPG, limitation protocol group; PEG, pendular exercise group; PPM, pacemaker; RCT, randomized control trial; SSEG, stretching and strengthening group; SWPG, stepwise protocol group.
Results of RCTs
| Author/year (country) | Outcome measures | Effectiveness of exercises (including p values/RR/CI) | Safety of exercises reported | Initiation of exercises | Adverse events with exercise | Reported limitations | Follow-ups |
|---|---|---|---|---|---|---|---|
| Wongcharoen et al. [28] (2019) | Shoulder ROM, QuickDASH-TH | Shoulder ROM: <30 degrees ROM reduction: lower incidence on the exercise group compared to the control group for both flexion (16.8% vs. 40.4%, RR 0.30 (95% CI 0.16–0.58), p < 0.001) and abduction (9.9% vs. 32.3%, RR 0.23 (95% CI 0.11–0.50), p < 0.001); >30 degrees ROM reduction: loss of shoulder ROM in the exercise group compared to the control group was significantly lower for flexion (2.0% vs. 10.1%, RR 0.18 (95% CI 0.04–0.84), p = 0.018 but not significant for abduction (3.0% vs. 7.1%, RR 0.40 (95% CI 0.10–1.60), p = 0.211) | Pendulum exercise with ipsilateral arm was safe from 1st POD | 1st POD | CG: Nil, EG: Nil | Short follow-up duration: it is unknown whether the beneficial effect of early shoulder exercise on shoulder function would be attenuated or more prominent after longer follow-up; downstream effects of the shoulder ROM reductions and incidence of frozen shoulder, in terms of costs or longer-term disability, are not known | 1 month in-hospital visit for both groups, telephone call 1 week after hospital discharge |
| QuickDASH-TH score: lower disability of shoulder function in the exercise group compared to control (15.2±16.4 vs. 23.4±18.1, p = 0.001) | |||||||
| Daniels et al. [11] (2011) | Shoulder Symptoms, VAS pain scale, QuickDASH, Impingement Test | Shoulder symptoms: 1 month: 7 of 21 control patients reported shoulder symptoms (increased pain) compared to 1 of 23 in the exercise group (p = 0.02); 6 months: 4 of 23 control patients reported worsening shoulder symptoms, compared to none in the exercise group (p = 0.11) | No complications related to exercise reported | During the first postoperative week visit | CG: nil, EG: Nil | Small number of participants, lack of blinded exercise intervention, young population, protocol may not be possible for elderly and/or debilitated patients | In-hospital follow-up visits at 1 month, 3 months, and 6 months for both groups, telephone calls for compliance verification with the exercise group at 2, 3, 5, and 6 postoperative weeks |
| VAS pain scale: change in mean VAS scores over time were significantly different for the two groups (p < 0.012); 1-month: control group on average reported significantly higher levels of pain compared to their baseline levels (mean±SD); VAS at baseline = 0.069±0.2 versus at 1-month follow-up = 1.73±0.4 (p < 0.001). For the exercise group, there was no such increase in the mean VAS scores | |||||||
| Impingement test: 1 month: 5 of 19 patients developed a positive impingement test versus none in the exercise group (p = 0.01); 6 months: 1 patient in the control and 2 in the exercise group tested positive for impingement (P= NS) | |||||||
| QuickDASH: change in mean scores over time was significantly different for the two groups (p < 0.03); | |||||||
| specifically, control group reported significantly higher mean DASH score compared to their baseline levels (mean±SD) (7.74±2.0) versus at 1-month follow-up = 14.78±2.9 (p < 0.005), while the exercise group did not have a significant change in mean DASH score over time | |||||||
| Jorat et al. [29] (2020) | Incidence of adhesive capsulitis | 11 patients had adhesive capsulitis 16 weeks after the initial visit; 7% (2) in group A and 27% (9) in group B (p = 0.004) | Not reported | No specific timeline reported | Not reported | Single-center study | 2nd week, 16th week |
| Cosgun et al. [34] (2022) | Grip strength, ROM, VAS pain scale, QuickDASH, SF36 | Grip strength: 2 weeks: three groups did not differ significantly; 2 months: PEG and SSEG did not differ significantly (40.2±9.6 and 43.6±11.2, respectively; p = 0.078); PEG and SSEG had significantly greater grip strength than the control group (35.4±10.1; p = 0.012 and p = 0.002, respectively) | Both stretching and strengthening group as well as pendular group are reported safe 2 weeks after implantation | At 2-week post-implantation | No adverse events in SSEG and PEG | Insufficient data on the long-term effects of upper arm exercises, small number of participants, no in-person follow-up visits between the 2-week and 2-month visits | 2 weeks, 2 months |
| ROM: 2 weeks: shoulder flexion and abduction were significantly impaired compared to baseline in 3 groups (p < 0.001, for each); 2 months: shoulder flexion and abduction ROM showed significant and similar improvement in the PEG (p = 0.002 and p = 0.001, respectively) and SSEG (p = 0.003 and p = 0.002, respectively) but not in the control group (p = 0.053 and p = 0.071, respectively) | |||||||
| VAS and QuickDASH: 2 weeks: three groups did not differ significantly; 2 months: mean VAS and QuickDASH scores of the PEG (0.9±0.4) and SSEG (0.8±0.3) were similar (p = 0.542) and significantly lower than the CG (1.6±0.6; p = 0.003 and p = 0.00, respectively) | |||||||
| SF36: 2 weeks: three groups did not differ significantly; 2 months: PEG and SSEG were similar (66.2±8.8 and 66.8±9.2, respectively; p = 0.412) and significantly greater than the CG (54.5±7.9; p = 0.007 and p = 0.003, respectively) |
| Author/year (country) | Outcome measures | Effectiveness of exercises (including p values/RR/CI) | Safety of exercises reported | Initiation of exercises | Adverse events with exercise | Reported limitations | Follow-ups |
|---|---|---|---|---|---|---|---|
| Wongcharoen et al. [28] (2019) | Shoulder ROM, QuickDASH-TH | Shoulder ROM: <30 degrees ROM reduction: lower incidence on the exercise group compared to the control group for both flexion (16.8% vs. 40.4%, RR 0.30 (95% CI 0.16–0.58), p < 0.001) and abduction (9.9% vs. 32.3%, RR 0.23 (95% CI 0.11–0.50), p < 0.001); >30 degrees ROM reduction: loss of shoulder ROM in the exercise group compared to the control group was significantly lower for flexion (2.0% vs. 10.1%, RR 0.18 (95% CI 0.04–0.84), p = 0.018 but not significant for abduction (3.0% vs. 7.1%, RR 0.40 (95% CI 0.10–1.60), p = 0.211) | Pendulum exercise with ipsilateral arm was safe from 1st POD | 1st POD | CG: Nil, EG: Nil | Short follow-up duration: it is unknown whether the beneficial effect of early shoulder exercise on shoulder function would be attenuated or more prominent after longer follow-up; downstream effects of the shoulder ROM reductions and incidence of frozen shoulder, in terms of costs or longer-term disability, are not known | 1 month in-hospital visit for both groups, telephone call 1 week after hospital discharge |
| QuickDASH-TH score: lower disability of shoulder function in the exercise group compared to control (15.2±16.4 vs. 23.4±18.1, p = 0.001) | |||||||
| Daniels et al. [11] (2011) | Shoulder Symptoms, VAS pain scale, QuickDASH, Impingement Test | Shoulder symptoms: 1 month: 7 of 21 control patients reported shoulder symptoms (increased pain) compared to 1 of 23 in the exercise group (p = 0.02); 6 months: 4 of 23 control patients reported worsening shoulder symptoms, compared to none in the exercise group (p = 0.11) | No complications related to exercise reported | During the first postoperative week visit | CG: nil, EG: Nil | Small number of participants, lack of blinded exercise intervention, young population, protocol may not be possible for elderly and/or debilitated patients | In-hospital follow-up visits at 1 month, 3 months, and 6 months for both groups, telephone calls for compliance verification with the exercise group at 2, 3, 5, and 6 postoperative weeks |
| VAS pain scale: change in mean VAS scores over time were significantly different for the two groups (p < 0.012); 1-month: control group on average reported significantly higher levels of pain compared to their baseline levels (mean±SD); VAS at baseline = 0.069±0.2 versus at 1-month follow-up = 1.73±0.4 (p < 0.001). For the exercise group, there was no such increase in the mean VAS scores | |||||||
| Impingement test: 1 month: 5 of 19 patients developed a positive impingement test versus none in the exercise group (p = 0.01); 6 months: 1 patient in the control and 2 in the exercise group tested positive for impingement (P= NS) | |||||||
| QuickDASH: change in mean scores over time was significantly different for the two groups (p < 0.03); | |||||||
| specifically, control group reported significantly higher mean DASH score compared to their baseline levels (mean±SD) (7.74±2.0) versus at 1-month follow-up = 14.78±2.9 (p < 0.005), while the exercise group did not have a significant change in mean DASH score over time | |||||||
| Jorat et al. [29] (2020) | Incidence of adhesive capsulitis | 11 patients had adhesive capsulitis 16 weeks after the initial visit; 7% (2) in group A and 27% (9) in group B (p = 0.004) | Not reported | No specific timeline reported | Not reported | Single-center study | 2nd week, 16th week |
| Cosgun et al. [34] (2022) | Grip strength, ROM, VAS pain scale, QuickDASH, SF36 | Grip strength: 2 weeks: three groups did not differ significantly; 2 months: PEG and SSEG did not differ significantly (40.2±9.6 and 43.6±11.2, respectively; p = 0.078); PEG and SSEG had significantly greater grip strength than the control group (35.4±10.1; p = 0.012 and p = 0.002, respectively) | Both stretching and strengthening group as well as pendular group are reported safe 2 weeks after implantation | At 2-week post-implantation | No adverse events in SSEG and PEG | Insufficient data on the long-term effects of upper arm exercises, small number of participants, no in-person follow-up visits between the 2-week and 2-month visits | 2 weeks, 2 months |
| ROM: 2 weeks: shoulder flexion and abduction were significantly impaired compared to baseline in 3 groups (p < 0.001, for each); 2 months: shoulder flexion and abduction ROM showed significant and similar improvement in the PEG (p = 0.002 and p = 0.001, respectively) and SSEG (p = 0.003 and p = 0.002, respectively) but not in the control group (p = 0.053 and p = 0.071, respectively) | |||||||
| VAS and QuickDASH: 2 weeks: three groups did not differ significantly; 2 months: mean VAS and QuickDASH scores of the PEG (0.9±0.4) and SSEG (0.8±0.3) were similar (p = 0.542) and significantly lower than the CG (1.6±0.6; p = 0.003 and p = 0.00, respectively) | |||||||
| SF36: 2 weeks: three groups did not differ significantly; 2 months: PEG and SSEG were similar (66.2±8.8 and 66.8±9.2, respectively; p = 0.412) and significantly greater than the CG (54.5±7.9; p = 0.007 and p = 0.003, respectively) |
CI, confidence intervals; CG, control group; EG, exercise group; NS, non-significant; PEG, pendular exercise group; POD, postoperative day; ROM, range of motion; RR, relative risk ratio; SD, standard deviation; SSEG, stretching and strengthening group; VAS, visual analog scale.
Results of non-RCTs
| Author/year (country) | Outcome measures | Safety of exercises reported | Initiation of exercises | Adverse events with exercise | Reported limitations | Follow-ups |
|---|---|---|---|---|---|---|
| Takeda et al. 2023 [32] (Japan) | Limitation in shoulder joint ROM, rate of complications, rate of complication with and without anticoagulation therapy | Results of this study indicate that raising the UE on the side of the CIED was safe and the use of rib belt may not have enough clinical advantage. There were no significant differences in either the rates of shoulder exercise-related complications (hematoma, lead dislodgement, and rising pacing threshold) and general complications (wound infection, pneumothorax, tamponade, and deep venous thrombosis) between the three groups | 1st postoperative day | Limitation protocol: | Insufficient details on frequency, intensity, and duration of exercises; all data collected from a single center; the degree of improvement in ROM being not clear | 1 month |
| hematoma = 3, | ||||||
| lead dislodgement = 3, | ||||||
| right ventricular lead = 3; | ||||||
| stepwise protocol: | ||||||
| hematoma = 6, | ||||||
| lead dislodgement = 10, | ||||||
| right ventricular lead = 7, | ||||||
| right atrial lead = 3; | ||||||
| early protocol: | ||||||
| hematoma = 5, | ||||||
| lead dislodgement = 2 | ||||||
| Naffe et al. 2009 [14] (USA) | Lead displacement confirmed by use of a noninvasive device programmer (Medtronic model 2090, Medtronic, Inc., Minneapolis, MN) | Patients can safely perform resistive ROM exercises soon after pacemaker/ICD | Between 2 and 24 h after the procedure | No adverse events reported | Small sample size | No follow-up |
| Author/year (country) | Outcome measures | Safety of exercises reported | Initiation of exercises | Adverse events with exercise | Reported limitations | Follow-ups |
|---|---|---|---|---|---|---|
| Takeda et al. 2023 [32] (Japan) | Limitation in shoulder joint ROM, rate of complications, rate of complication with and without anticoagulation therapy | Results of this study indicate that raising the UE on the side of the CIED was safe and the use of rib belt may not have enough clinical advantage. There were no significant differences in either the rates of shoulder exercise-related complications (hematoma, lead dislodgement, and rising pacing threshold) and general complications (wound infection, pneumothorax, tamponade, and deep venous thrombosis) between the three groups | 1st postoperative day | Limitation protocol: | Insufficient details on frequency, intensity, and duration of exercises; all data collected from a single center; the degree of improvement in ROM being not clear | 1 month |
| hematoma = 3, | ||||||
| lead dislodgement = 3, | ||||||
| right ventricular lead = 3; | ||||||
| stepwise protocol: | ||||||
| hematoma = 6, | ||||||
| lead dislodgement = 10, | ||||||
| right ventricular lead = 7, | ||||||
| right atrial lead = 3; | ||||||
| early protocol: | ||||||
| hematoma = 5, | ||||||
| lead dislodgement = 2 | ||||||
| Naffe et al. 2009 [14] (USA) | Lead displacement confirmed by use of a noninvasive device programmer (Medtronic model 2090, Medtronic, Inc., Minneapolis, MN) | Patients can safely perform resistive ROM exercises soon after pacemaker/ICD | Between 2 and 24 h after the procedure | No adverse events reported | Small sample size | No follow-up |
ROM, range of motion; CIED, cardiac implantable electronic device; ICD, implantable cardioverter-defibrillator.
Safety of UE Exercise after CIED Implantation
Two of the included studies [14, 32] focused only on the safety of exercises after CIED implantation. One of these studies [32] investigated the safety of raising the UE above the head on the ipsilateral side of the CIED implantation postoperatively. This study defined the following as complications: hematoma, swelling, wound dehiscence, lead dislodge, pacing threshold, or lead impedance values requiring re-treatment, wound infection, pneumothorax, tamponade, and venous obstruction. The participants were divided into two experimental groups, based on shoulder ROM progression, and a control group. One experimental group progressed gradually to achieve 180 degrees of ipsilateral shoulder flexion and abduction by the fourth postoperative day (POD) while the other experimental group was allowed to rise up to 180 degrees from the first POD. The study concluded there was no significant difference in complication rates among the control and experimental groups. The other study [14] initiated resisted exercises between 2 and 24 h after the implantation and also demonstrated the safety of exercise. Similarly, other studies [11, 14, 28, 30] whose primary outcome was the effectiveness of shoulder exercises or UE exercises, did not report any adverse events, indicating the safety of performing UE exercises after CIED implantation (Tables 2, 3).
Effectiveness of UE Exercise after CIED Implantation
Four of the studies [11, 28‒30] examined the effect of various shoulder ROM exercises, and/or strengthening and/or stretching exercises on shoulder dysfunction and subsequent disability. The studies analyzed the impact of an exercise program after CIED implantation on pain, ROM, strength and quality of life (QOL). The outcomes were reported using Short Form 36 (SF36), Quick DASH-TH [28], Quick DASH [11, 30], VAS for pain [11, 29, 30], ROM [28‒30], impingement test [11], and grip strength [30].
All the studies demonstrated a significant association between UE exercise and reduced incidence of UE dysfunction and disability after CIED implantation (Table 1). One of the studies compared the effect of pendulum exercise versus stretching and strengthening exercises, both types demonstrating being equally effective in reducing UE dysfunction [30]. This study reported a significant impairment of shoulder function at 2 weeks post CIED implantation. Also, at 2 weeks, exercises were initiated, which resulted in a significant improvement in shoulder function at the 2-month follow-up (Tables 2, 3) [30].
Type and Initiation Timing for UE Exercise after CIED Implantation
The exercises used in the reported intervention were shoulder pendular exercises [28, 29], shoulder ROM exercises [32], and various shoulder stretching [11, 30] and strengthening exercises [11, 14, 29, 30] to prevent UE dysfunction after CIED implantation. Table 1 describes the details of each exercise intervention.
Five [11, 14, 28, 30, 32] of the 6 studies reported the initiation time of the exercise program after CIED implantation (Fig. 1): one study [14] reported initiation at less than 24-h post-CIED implantation; two studies [28, 32] initiated exercise at the first POD, one study [11] at the first postoperative week, and finally another one study [30] at 2-week post-implantation (Tables 2, 3).
Methodological Quality
The four RCTs [11, 28‒30] were appraised using the Cochrane Risk of Bias (RoB2) Assessment Tool. Out of the four RCTs, two were average [28, 30] quality RCTs while the other two [11, 29] were low-quality RCTs. Daniel et al. 2011 was rated as a low-quality RCT due to high risk for performance, detection, and reporting bias. Jorat et al. 2020 was rated as a low-quality RCT due to high risk for selection bias, performance bias, detection bias, attrition bias and moderate risk for reporting bias. Wongcharoen et al. 2019 was rated as an average-quality RCT due to moderate risk for performance bias and high risk for reporting bias. Cosgun et al. 2022 study was rated as an average-quality RCT due to moderate risk for selection bias and moderate risk for reporting bias. Naffe et al. 2009 was assessed as an average-quality study using JBI critical appraisal checklist for cohort studies [33]. Finally, Takeda et al. 2023 was assessed using JBI critical appraisal checklist for case control studies [33], which showed that it is a high-quality study.
Discussion
This systematic scoping review explored the current available evidence pertaining to safety, effectiveness, types of exercise, and appropriate time for initiation of an exercise program after CIED implantation. To the best of our knowledge, no current reviews have investigated the safety and effectiveness of UE exercise, and both the appropriate type of exercise and time for initiation after CIED implantation.
In this review, most studies have indicated certain levels of evidence for the efficacy of UE exercise in terms of improvements in ROM, HRQOL, and muscle strength after CIED implantation (Tables 2, 3). The two studies [14, 32] that initiated UE exercise on the ipsilateral side of the CIED, including overhead ROM, from the first POD, did not compromise postoperative safety. These studies also indicated the safety of avoiding the chest belt from the first postoperative day. The chest belt and sling immobilization practices following CIED implantation are commonly used to immobilize the ipsilateral arm and reduce the risk of lead displacement. However, these overly restrictive practices may lead to muscle atrophy and weakness, promote fear, and potentially hinder early recovery.
Recent studies have reported that the majority of patients experience UE dysfunction after CIED implantation [9, 34]. A recent systematic review [9] of 8 studies, including three cross-sectional studies, three prospective observational studies, and two case reports, concluded that the majority of patients experienced UE dysfunction shortly after CIED implantation. Among the 696 participants in the review, the most prevalent UE dysfunctions were shoulder joint pain and ROM limitation in the shoulder joint. Three of the studies also reported the rate of UE dysfunction at 12 months or more post CIED implantation to be 50% [35], 41% [2], and 10% [10]. Another independent single-center, cross-sectional study [34] with 60 participants (30 in the CG and 30 in the SG), has also recently reported a significant loss in shoulder joint ROM and grip strength among the study group after CIED implantation. The most common contributing factors of UE dysfunctions were the dimension of the implanted device, pectoral implantation pocket, and the UE immobilization practices after implantation [9].
Considering the importance of upper extremity (UE) function in daily activities, dysfunction in UE significantly impact quality of life [18, 36]. Overhead activities, such as dressing, grooming, and personal hygiene, require shoulder flexion, abduction exceeding 130°, and extension exceeding 60° [18, 19]. Therefore, restricted shoulder range of motion (ROM) can substantially hinder an individual’s capacity for performing ADL. Furthermore, compensatory movements resulting from limited ROM during various daily tasks may increase the risk of soft tissue injuries and degenerative diseases [37, 38]. Hence, it is crucial to preserve or restore shoulder joint ROM, especially after the implantation of a CIED [19].
This scoping review demonstrates insufficient evidence to guide the clinician about the type of exercises to use, and the appropriate time to initiate the exercise program after CIED implantation. Studies varied in regards to the exercise protocol with respect to the type of exercise and its initiation time. This variation in practice highlights the lack of consistency in practice and intervention type. Due to the quality and variability of these studies, it is advisable to adopt caution when generalizing these results. Further high-quality studies will be required to understand the effectiveness of various exercise protocols in reducing UE dysfunctions.
Strength and Limitations of This Review
This systematic scoping review was done in line with current recommendations [24, 25]. Rigorous and systematic methods were used throughout the entire process. Comprehensive search in 5 databases ensured a broad search of the literature and several different study designs were included. Five reviewers were independently involved in the data extraction and verification process. Methodological quality assessment for each individual study was performed by three reviewers using a validated Risk of Bias Assessment tool [31, 39, 40]. All disagreements regarding data extraction and quality analysis were resolved by consensus.
Studies not published in English were excluded from this review. Additionally, gray literature was not searched. The data gathered was highly heterogeneous, therefore statistical pooling would not have been appropriate.
Conclusions
This scoping review maps out the available literature exploring the safety, effectiveness, type, and initiation timing for UE rehabilitative exercise shortly after CIED implantation. A limited number of low-to-average quality RCTs and other lower quality study designs are available. This review provides evidence for the safety and benefits of UE exercise on reducing UE dysfunction (ROM, pain, and muscle strength), and improving HRQOL after CIED implantation. However, further higher-quality research needs to confirm the observed safety and positive effects. The limitations identified in the existing literature provide insight for the design of future adequately powered research studies. Focus should be on developing a safe and effective exercise program, and understanding the appropriate time for initiating UE exercises after CIED implantation.
Acknowledgments
We would like to acknowledge and thank Mrs. Whitney Jo Timp, for her esteemed and invaluable help with manuscript reviewing and language editing.
Statement of Ethics
A Statement of Ethics is not applicable because this study is based exclusively on published literature.
Conflict of Interest Statement
The authors have no conflicts of interest to declare.
Funding Sources
Open Access funding provided by Qatar National Library.
Author Contributions
All authors were involved in the drafting the article or revising it critically for important intellectual content, and all authors approved the final version to be published. P.J.S. and P.J. were responsible for the concept and design of this review. P.J.S., P.J., J.L.D., G.M., D.K.S. performed data extraction and collection. Methodological quality appraisal was conducted by P.J.S., P.J., and N.S. Manuscript writing and all tables, figures and online supplementary material were done by P.J.S., P.J. and J.L.D.
Data Availability Statement
All data relevant to the study are included in the article. Further inquiries can be directed to the corresponding author.
References
