Virtual Physical Activity Seated Exercise - Phase 2

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessing a Telehealth Seated Exercise Program on Post-stroke Balance and Mobility: A Mixed-method Design

Conditions
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Stroke, Chronic Stroke, Stroke, Ischemic, Stroke Hemorrhagic

Intervention / Treatment
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* Other: Virtual Physical Activity Seated Exercises (V-PASE)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10-week group<br>Will receive a 10-week seated exercise program, occurring 3 times per week. Sessions will be 60 minutes in duration. | Other: Virtual Physical Activity Seated Exercises (V-PASE)<br>* The seated exercise program includes a variety of upper and lower limb strengthening, core strengthening, agility (fast arm and leg movements), and flexibility exercises. Participants will be supervised during each session thru videoconferencing by a trained instructor.<br>|
| No Intervention: Delayed 2-week group (Boot Camp)<br>The Boot Camp group will complete a 2-week seated exercise program following the 10-week active trial period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 Second Sit-to-Stand | Assessment of balance and lower extremity strength. | Immediately post-intervention (following 10-week trial) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go | Participants stand up from a chair, walk 3 metres, turn around and then sit back down. The TUG assesses balance, mobility and turning ability | Immediately post-intervention, and retention (2-months post-intervention) | 
| Tandem Stance | Measures balance in standing as reported in the Short Physical Performance Battery Protocol | Immediately post-intervention, and retention (2-months post-intervention) | 
| Modified Telehealth Fugl-Meyer | The modified virtual Fugl-Meyer assess lower extremity impairments in those with stroke | Immediately post-intervention, and retention (2-months post-intervention) | 
| Stroke Impact Scale | 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. | Immediately post-intervention, and retention (2-months post-intervention) | 
| Activities-Specific Balance Confidence (ABC) | 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). | Immediately post-intervention, and retention (2-months post-intervention) | 
| Fatigue Severity Scale | 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). | Immediately post-intervention, and retention (2-months post-intervention) | 
| Quality of Life (EQ-5D-5L) | 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). | Immediately post-intervention, and retention (2-months post-intervention) | 
| Patient Health Questionnaire-4 (PHQ-4) | The PHQ-4 focuses on depression and anxiety. Questions are scored from 0 to 3 (0=not at all; 3 = Nearly every day). | Immediately post-intervention, and retention (2-months post-intervention) | 
| Montreal Cognitive Assessment scale (MoCA-BLIND) | 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). | Immediately post-intervention, and retention (2-months post-intervention) | 
| Lipid Profiles | Blood samples will be collected following a 12-hour over-night fast | Immediately post-intervention, and retention (2-months post-intervention) | 
| Fasting Glucose | Blood samples will be collected following a 12-hour over-night fast | Immediately post-intervention, and retention (2-months post-intervention) | 
| Glucose (HbA1c) | Blood samples will be collected following a 12-hour over-night fast | Immediately post-intervention, and retention (2-months post-intervention) | 
| 30 Second Sit-to-Stand | Assessment of balance and lower extremity strength. | Retention (2-months post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Seated Exercise, Balance, Mobility, Cardiometabolic health, Randomized Controlled Trial