Abstract
Background: Increasing physical activity (PA) and improving diet quality are opportunities to improve secondary stroke prevention, but access to appropriate services is limited. Interventions co-designed with stroke survivors and delivered by telehealth are a potential solution. Aim: The aim of this study is to test the feasibility, safety, and potential efficacy of a 6-month, telehealth-delivered PA and/or dietary (DIET) intervention. Methods: Pilot randomized trial. 80 adults with previous stroke who are living at home with Internet access and able to exercise will be randomized in a 2 × 2 factorial (4-arm) pilot randomized, open-label, blinded outcome assessment trial to receive PA, DIET, PA + DIET, or control interventions via telehealth. The PA intervention aims to support participants to meet the minimum recommended levels of PA (150 min/week moderate exercise), and the DIET intervention aims to support participants to follow the AusMed (Mediterranean-style) diet. The control group receives usual care plus education about PA and healthy eating. The co-primary outcomes are feasibility (proportion and characteristics of eligible participants enrolled and proportion of scheduled intervention sessions attended) and safety (adverse events) at 6 months. The secondary outcomes include recurrent stroke risk factors (blood pressure, physical activity levels, and diet quality), fatigue, mood, and quality of life. Outcomes are measured at 3, 6, and 12 months. Conclusion: This trial will produce evidence for the feasibility, safety, and potential effect of telehealth-delivered PA and DIET interventions for people with stroke. Results will inform development of an appropriately powered trial to test effectiveness to reduce major risk factors for recurrent stroke. Trial registration: ACTRN12620000189921.
References
1.
Rothwell
PM
, Coull
AJ
, Giles
MF
, Howard
SC
, Silver
LE
, Bull
LM
, Change in stroke incidence, mortality, case-fatality, severity, and risk factors in Oxfordshire, UK from 1981 to 2004 (Oxford Vascular Study)
. Lancet
. 2004
;363
(9425
):1925
–33
. .2.
Hankey
GJ
. Secondary stroke prevention
. Lancet Neurol
. 2014
;13
(2
):178
–94
. .3.
Amarenco
P
; Steering Committee and Investigators of the TIAregistry.org Project
. Five-year risk of stroke after TIA or minor ischemic stroke
. N Engl J Med
. 2018
;379
(16
):1580
–1
.4.
Johnston
SC
, Easton
JD
, Farrant
M
, Barsan
W
, Conwit
RA
, Elm
JJ
, Clopidogrel and aspirin in acute ischemic stroke and high-risk TIA
. N Engl J Med
. 2018
;379
(3
):215
–25
. .5.
NoPostcode2017_web.pdf.
6.
Garcia
RM
, Yoon
S
, Cage
T
, Potts
MB
, Lawton
MT
. Ethnicity, race, and post-operative stroke risk among 53,593 patients with asymptomatic carotid stenosis undergoing revascularization
. World Neurosurg
. 2017
;108
:246
–53
. .7.
O’Donnell
MJ
, Chin
SL
, Rangarajan
S
, Xavier
D
, Liu
L
, Zhang
H
, Global and regional effects of potentially modifiable risk factors associated with acute stroke in 32 countries (INTERSTROKE): a case-control study
. Lancet
. 2016
;388
(10046
):761
–75
. .8.
D’Isabella
NT
, Shkredova
DA
, Richardson
JA
, Tang
A
. Effects of exercise on cardiovascular risk factors following stroke or transient ischemic attack: a systematic review and meta-analysis
. Clin Rehabil
. 2017
;31
(12
):1561
–72
. .9.
Estruch
R
, Ros
E
, Salas-Salvadó
J
, Covas
MI
, Corella
D
, Arós
F
, Primary prevention of cardiovascular disease with a mediterranean diet supplemented with extra-virgin olive oil or nuts
. N Engl J Med
. 2018
;378
(25
):e34
. .10.
Becerra-Tomas
N
, Blanco Mejia
S
, Viguiliouk
E
, Khan
T
, Kendall
CWC
, Kahleova
H
, Mediterranean diet, cardiovascular disease and mortality in diabetes: a systematic review and meta-analysis of prospective cohort studies and randomized clinical trials
. Crit Rev Food Sci Nutr
. 2020
;60
(7
):1207
–27
.11.
Boyne
P
, Billinger
S
, MacKay-Lyons
M
, Barney
B
, Khoury
J
, Dunning
K
. Aerobic exercise prescription in stroke rehabilitation: a web-based survey of US physical therapists
. J Neurol Phys Ther
. 2017
;41
(2
):119
–28
. .12.
Ahmadi
M
, Laumeier
I
, Ihl
T
, Steinicke
M
, Ferse
C
, Endres
M
, A support programme for secondary prevention in patients with transient ischaemic attack and minor stroke (INSPiRE-TMS): an open-label, randomised controlled trial
. Lancet Neurol
. 2020
;19
(1
):49
–60
. .13.
Olaiya
MT
, Cadilhac
DA
, Kim
J
, Nelson
MR
, Srikanth
VK
, Gerraty
RP
, Community-based intervention to improve cardiometabolic targets in patients with stroke: a randomized controlled trial
. Stroke
. 2017
;48
(9
):2504
–10
. .14.
Deijle
IA
, Van Schaik
SM
, Van Wegen
EE
, Weinstein
HC
, Kwakkel
G
, Van den Berg-Vos
RM
. Lifestyle interventions to prevent cardiovascular events after stroke and transient ischemic attack: systematic review and meta-analysis
. Stroke
. 2017
;48
(1
):174
–9
. .15.
Moller
G
, Andersen
HK
, Snorgaard
O
. A systematic review and meta-analysis of nutrition therapy compared with dietary advice in patients with type 2 diabetes
. Am J Clin Nutr
. 2017
;106
(6
):1394
–400
.16.
Galloway
M
, Marsden
DL
, Callister
R
, Nilsson
M
, Erickson
KI
, English
C
. The feasibility of a telehealth exercise program aimed at increasing cardiorespiratory fitness for people after stroke
. Int J Telerehab
. 2019
;11
(2
):9
–28
. .17.
Zacharia
K
, Patterson
AJ
, English
C
, MacDonald-Wicks
L
. Feasibility of the AusMed diet program: translating the mediterranean diet for older Australians
. Nutrients
. 2020
;12
(4
):1044
. .18.
Eldridge
SM
, Chan
CL
, Campbell
MJ
, Bond
CM
, Hopewell
S
, Thabane
L
, CONSORT 2010 statement: extension to randomised pilot and feasibility trials
. Pilot Feasibility Stud
. 2016
;2
:64
. .19.
Cleland
C
, Ferguson
S
, Ellis
G
, Hunter
RF
. Validity of the international physical activity questionnaire (IPAQ) for assessing moderate-to-vigorous physical activity and sedentary behaviour of older adults in the United Kingdom
. BMC Med Res Methodol
. 2018
;18
(1
):176
. .20.
Estruch
R
, Ros
E
, Salas-Salvadó
J
, Covas
MI
, Corella
D
, Arós
F
, Primary prevention of cardiovascular disease with a mediterranean diet
. N Engl J Med
. 2013
;368
(14
):1279
–90
. .21.
Norton
K
, Norton
L
, Sadgrove
D
. Position statement on physical activity and exercise intensity terminology
. J Sci Med Sport
. 2010
;13
(5
):496
–502
. .22.
Michie
S
, Ashford
S
, Sniehotta
FF
, Dombrowski
SU
, Bishop
A
, French
DP
. A refined taxonomy of behaviour change techniques to help people change their physical activity and healthy eating behaviours: the CALO-RE taxonomy
. Psychol Health
. 2011
;26
(11
):1479
–98
. .23.
Consortium
T
. Recommended standards for assessing blood pressure in human research where blood pressure or hypertension is a major focus
. Clin Exp Hypertens
. 2018
;40
(6
):509
–13
. .24.
Winkler
EA
, Bodicoat
DH
, Healy
GN
, Bakrania
K
, Yates
T
, Owen
N
, Identifying adults’ valid waking wear time by automated estimation in activPAL data collected with a 24 h wear protocol
. Physiol Meas
. 2016
;37
(10
):1653
–68
. .25.
Powell
C
, Carson
BP
, Dowd
KP
, Donnelly
AE
. Simultaneous validation of five activity monitors for use in adult populations
. Scand J Med Sci Sports
. 2017
;27
(12
):1881
–92
. .26.
Collins
CE
, Boggess
MM
, Watson
JF
, Guest
M
, Duncanson
K
, Pezdirc
K
, Reproducibility and comparative validity of a food frequency questionnaire for Australian adults
. Clin Nutr
. 2014
;33
(5
):906
–14
. .27.
Glasgow
RE
, Harden
SM
, Gaglio
B
, Rabin
B
, Smith
ML
, Porter
GC
, RE-AIM planning and evaluation framework: adapting to new science and practice with a 20-year review
. Front Public Health
. 2019
;7
:64
. .28.
Michie
S
, van Stralen
MM
, West
R
. The behaviour change wheel: a new method for characterising and designing behaviour change interventions
. Implement Sci
. 2011
;6
:42
. .29.
Braun
V
, Clarke
V
. Using thematic analysis in psychology
. Qual Res Psychol
. 2006
;3
(2
):77
–101
. .30.
Walker
MF
, Hoffmann
TC
, Brady
MC
, Dean
CM
, Eng
JJ
, Farrin
AJ
, Improving the development, monitoring and reporting of stroke rehabilitation research: consensus-based core recommendations from the stroke recovery and rehabilitation roundtable
. Int J Stroke
. 2017
;12
(5
):472
–9
. .31.
Kwakkel
G
, Lannin
NA
, Borschmann
K
, English
C
, Ali
M
, Churilov
L
, Standardized measurement of sensorimotor recovery in stroke trials: consensus-based core recommendations from the stroke recovery and rehabilitation roundtable
. Int J Stroke
. 2017
;12
(5
):451
–61
. .32.
Bernhardt
J
, Hayward
KS
, Dancause
N
, Lannin
NA
, Ward
NS
, Nudo
RJ
, A stroke recovery trial development framework: consensus-based core recommendations from the second stroke recovery and rehabilitation roundtable
. Neurorehabil Neural Repair
. 2019
;33
(11
):959
–69
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