Virtual Physical Activity Seated Exercise - Phase 2
- Conditions
- Stroke HemorrhagicStroke, IschemicStrokeChronic Stroke
- Interventions
- Other: Virtual Physical Activity Seated Exercises (V-PASE)
- Registration Number
- NCT05724823
- Lead Sponsor
- University of British Columbia
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10-week group Virtual Physical Activity Seated Exercises (V-PASE) Will receive a 10-week seated exercise program, occurring 3 times per week. Sessions will be 60 minutes in duration.
- Primary Outcome Measures
Name Time Method 30 Second Sit-to-Stand Immediately post-intervention (following 10-week trial) Assessment of balance and lower extremity strength.
- Secondary Outcome Measures
Name Time Method Glucose (HbA1c) Immediately post-intervention, and retention (2-months post-intervention) Blood samples will be collected following a 12-hour over-night fast
Stroke Impact Scale Immediately post-intervention, and retention (2-months post-intervention) A self-reported measure of stroke-related disability. There are 8 domains with each item rated using a 5-point Likert scale, where lower scores mean greater difficulty to complete the item.
Fatigue Severity Scale Immediately post-intervention, and retention (2-months post-intervention) Questionnaire assessing the impact of fatigue on daily tasks and activities. There are 9 questions, each scored from 1 to 7 (1 = strongly disagree; 7 = strong agreement).
Montreal Cognitive Assessment scale (MoCA-BLIND) Immediately post-intervention, and retention (2-months post-intervention) The MoCA-BLIND assess six different cognitive domains (excludes visual stimulus) over the phone: memory, attention, language, abstraction, delayed recall, and orientation. The MoCA-BLIND is scored from 0-22 (22 = no cognitive impairments).
Activities-Specific Balance Confidence (ABC) Immediately post-intervention, and retention (2-months post-intervention) The ABC scale is a 16-item questionnaire where a participant rates their confidence in performing activities from 0% to 100% (higher percentages indicate greater self-efficacy).
Timed Up and Go Immediately post-intervention, and retention (2-months post-intervention) Participants stand up from a chair, walk 3 metres, turn around and then sit back down. The TUG assesses balance, mobility and turning ability
Tandem Stance Immediately post-intervention, and retention (2-months post-intervention) Measures balance in standing as reported in the Short Physical Performance Battery Protocol
Modified Telehealth Fugl-Meyer Immediately post-intervention, and retention (2-months post-intervention) The modified virtual Fugl-Meyer assess lower extremity impairments in those with stroke
Quality of Life (EQ-5D-5L) Immediately post-intervention, and retention (2-months post-intervention) The EQ-5D-5L assess self-care, mobility, depression/anxiety, pain, and usual activities. Each is scored with 5 levels (1=no problems, 5=major problems). Overall health on the day is scored from 0% (worst health) to 100% (best health).
Patient Health Questionnaire-4 (PHQ-4) Immediately post-intervention, and retention (2-months post-intervention) The PHQ-4 focuses on depression and anxiety. Questions are scored from 0 to 3 (0=not at all; 3 = Nearly every day).
Lipid Profiles Immediately post-intervention, and retention (2-months post-intervention) Blood samples will be collected following a 12-hour over-night fast
Fasting Glucose Immediately post-intervention, and retention (2-months post-intervention) Blood samples will be collected following a 12-hour over-night fast
30 Second Sit-to-Stand Retention (2-months post-intervention) Assessment of balance and lower extremity strength.
Trial Locations
- Locations (5)
University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
GF Strong Rehabilitation Centre
🇨🇦Vancouver, British Columbia, Canada
Nova Scotia Health
🇨🇦Halifax, Nova Scotia, Canada
Western University
🇨🇦London, Ontario, Canada
University of Saskatchewan
🇨🇦Saskatoon, Saskatchewan, Canada