Chronic Stroke, Stroke, Stroke Hemorrhagic, Stroke, Ischemic
Conditions
Keywords
Stroke, Seated Exercise, Balance, Mobility, Cardiometabolic health, Randomized Controlled Trial
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.
Interventions
OTHERVirtual Physical Activity Seated Exercises (V-PASE)
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.
Sponsors
Canadian Institutes of Health Research (CIHR)
Michael Smith Foundation for Health Research
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30 Second Sit-to-Stand | Immediately post-intervention (following 10-week trial) | Assessment of balance and lower extremity strength. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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). |
| 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). |
| 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). |
| Glucose (HbA1c) | 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. |
| 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). |
| 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). |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Indicator: Compliance | Through study completion (approximately 10 weeks) | Percentage of participants that attend exercise sessions. |
| Feasibility Indicator: Safety | Through study completion (approximately 10 weeks) | Number of adverse events that occur during assessments or exercise sessions. |
Countries
Canada
Contacts
Primary ContactChihya Hung, MScPT
Outcome results
None listed