Assessing a Telehealth Seated Exercise Program on Post-stroke Balance and Mobility: A Mixed-method Design
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 100
- Locations
- 5
- Primary Endpoint
- 30 Second Sit-to-Stand
Study Overview
Brief Summary
This study will determine the acceptability of delivering seated exercises online and if seated exercises can improve balance, mobility, quality of life, and cardiometabolic health in those living with a stroke related mobility impairment.
Participants will be allocated to either a 10-week seated exercise program or a delayed 2-week Boot Camp program. All seated exercises sessions and assessments will be conducted virtually.
Detailed Description
The study will be a virtual 10-week multi-site, assessor-blinded, randomized controlled trial with an embedded qualitative component. The study will be conducted in real time using secure videoconferencing software (Zoom). Participants will be randomized 1:1 to a 10-week Seated Exercise group or a delayed 2-week Seated Exercise Group (Boot Camp). Seated exercise sessions will be delivered and supervised by a trained instructor.
Participants will use their own computer, laptop, or tablet for the zoom sessions. No Zoom sessions will be recorded. Caregivers will be invited to attend each exercise session to provide support and assistance but are not obliged to attend. A caregiver, friend, or family member will be required for each assessment to participate in the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants must meet the following inclusion criteria:
- •Adult (as defined by Province)
- •Chronic stroke (more than 6 months post-stroke)
- •Ability to stand up from a chair
- •Mobility impairment of lower extremity (requires a walking aid, with or without close supervision)
- •Able to safely engage in exercise and tolerate 60 minutes of exercises
- •Able to communicate in English
- •Have access to a tablet, computer, or laptop with internet and email access
Exclusion Criteria
- •Participants will be excluded if they meet any of the following criteria:
- •Participating in formal exercise or rehabilitation activities
- •Participating in > 30 minutes/day of physical activity (moderate intensity)
- •Participating in another study that may affect outcomes to this study
- •Severe loss of vision, hearing, speech (including aphasia) or cognition that would preclude use of a computer/tablet and communication over videoconference software
- •A serious comorbid condition (eg., amputation, Parkinson's disease, active cancer)
- •Clinically diagnosed with acute/chronic illness or other condition which has known physical activity contraindications or limits their ability to complete each experimental condition (i.e., chronic low back pain aggravated by prolonged sitting)
Arms & Interventions
10-week group
Will receive a 10-week seated exercise program, occurring 3 times per week. Sessions will be 60 minutes in duration.
Intervention: Virtual Physical Activity Seated Exercises (V-PASE) (Other)
Delayed 2-week group (Boot Camp)
The Boot Camp group will complete a 2-week seated exercise program following the 10-week active trial period.
Outcomes
Primary Outcomes
30 Second Sit-to-Stand
Time Frame: Immediately post-intervention (following 10-week trial)
Assessment of balance and lower extremity strength.
Secondary Outcomes
- Stroke Impact Scale(Immediately post-intervention, and retention (2-months post-intervention))
- Fatigue Severity Scale(Immediately post-intervention, and retention (2-months post-intervention))
- Montreal Cognitive Assessment scale (MoCA-BLIND)(Immediately post-intervention, and retention (2-months post-intervention))
- Glucose (HbA1c)(Immediately post-intervention, and retention (2-months post-intervention))
- Timed Up and Go(Immediately post-intervention, and retention (2-months post-intervention))
- Tandem Stance(Immediately post-intervention, and retention (2-months post-intervention))
- Modified Telehealth Fugl-Meyer(Immediately post-intervention, and retention (2-months post-intervention))
- Activities-Specific Balance Confidence (ABC)(Immediately post-intervention, and retention (2-months post-intervention))
- Quality of Life (EQ-5D-5L)(Immediately post-intervention, and retention (2-months post-intervention))
- Patient Health Questionnaire-4 (PHQ-4)(Immediately post-intervention, and retention (2-months post-intervention))
- Lipid Profiles(Immediately post-intervention, and retention (2-months post-intervention))
- Fasting Glucose(Immediately post-intervention, and retention (2-months post-intervention))
- 30 Second Sit-to-Stand(Retention (2-months post-intervention))
Investigators
Janice Eng
Professor
University of British Columbia