TY - JOUR
T1 - Secondary prevention of stroke. A telehealth-delivered physical activity and diet pilot randomized trial (ENAbLE-pilot)
AU - English, Coralie
AU - Ramage, Emily R.
AU - Attia, John
AU - Bernhardt, Julie
AU - Bonevski, Billie
AU - Burke, Meredith
AU - Galloway, Margaret
AU - Hankey, Graeme J.
AU - Janssen, Heidi
AU - Lindley, Richard
AU - Lynch, Elizabeth
AU - Oldmeadow, Chris
AU - Said, Catherine M.
AU - Spratt, Neil J.
AU - Zacharia, Karly
AU - MacDonald-Wicks, Lesley
AU - Patterson, Amanda
PY - 2024/2
Y1 - 2024/2
N2 - Background: Improving physical activity levels and diet quality are important for secondary stroke prevention. Aim: To test the feasibility and safety of 6-month, co-designed telehealth-delivered interventions to increase physical activity and improve diet quality. Methods: A 2 × 2 factorial trial (physical activity (PA); diet (DIET); PA + DIET; control) randomized, open-label, blinded endpoint trial. Primary outcomes were feasibility and safety. Secondary outcomes included stroke risk factors (blood pressure, self-report PA (International Physical Activity Questionnaire (IPAQ)) and diet quality (Australian Recommended Food Score (ARFS)), and quality of life. Between-group differences were analyzed using linear-mixed models. Results: Over 23 months, 99 people were screened for participation and 40 (40%) randomized (3 months to 10 years post-stroke, mean age 59 (16) years). Six participants withdrew, and an additional five were lost to follow-up. Fifteen serious adverse events were reported, but none were deemed definitely or probably related to the intervention. Median attendance was 32 (of 36) PA sessions and 9 (of 10) DIET sessions. The proportion of missing primary outcome data (blood pressure) was 3% at 3 months, 11% at 6 months, and 14% at 12 months. Between-group 95% confidence intervals showed promising, clinically relevant differences in support of the interventions across the range of PA, diet quality, and blood pressure outcomes. Conclusion: Our telehealth PA and diet interventions were safe and feasible and may have led to significant behavior change. Trial Registration: ACTRN12620000189921.
AB - Background: Improving physical activity levels and diet quality are important for secondary stroke prevention. Aim: To test the feasibility and safety of 6-month, co-designed telehealth-delivered interventions to increase physical activity and improve diet quality. Methods: A 2 × 2 factorial trial (physical activity (PA); diet (DIET); PA + DIET; control) randomized, open-label, blinded endpoint trial. Primary outcomes were feasibility and safety. Secondary outcomes included stroke risk factors (blood pressure, self-report PA (International Physical Activity Questionnaire (IPAQ)) and diet quality (Australian Recommended Food Score (ARFS)), and quality of life. Between-group differences were analyzed using linear-mixed models. Results: Over 23 months, 99 people were screened for participation and 40 (40%) randomized (3 months to 10 years post-stroke, mean age 59 (16) years). Six participants withdrew, and an additional five were lost to follow-up. Fifteen serious adverse events were reported, but none were deemed definitely or probably related to the intervention. Median attendance was 32 (of 36) PA sessions and 9 (of 10) DIET sessions. The proportion of missing primary outcome data (blood pressure) was 3% at 3 months, 11% at 6 months, and 14% at 12 months. Between-group 95% confidence intervals showed promising, clinically relevant differences in support of the interventions across the range of PA, diet quality, and blood pressure outcomes. Conclusion: Our telehealth PA and diet interventions were safe and feasible and may have led to significant behavior change. Trial Registration: ACTRN12620000189921.
KW - blood pressure
KW - diet
KW - Physical activity
KW - pilot trial
KW - quality of life
KW - telehealth
UR - http://www.scopus.com/inward/record.url?scp=85173521627&partnerID=8YFLogxK
UR - http://purl.org/au-research/grants/NHMRC/1149987
UR - http://purl.org/au-research/grants/NHMRC/1138515
U2 - 10.1177/17474930231201360
DO - 10.1177/17474930231201360
M3 - Article
C2 - 37658738
AN - SCOPUS:85173521627
SN - 1747-4930
VL - 19
SP - 199
EP - 208
JO - International Journal of Stroke
JF - International Journal of Stroke
IS - 2
ER -