Assessing a Telehealth Seated Exercise Program on Post-stroke Balance and Mobility: a Mixed-method Design
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- 30 Second Sit-to-Stand
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
30 Second Sit-to-Stand
时间窗: Immediately post-intervention (following 10-week trial)
Assessment of balance and lower extremity strength.
次要结局
- 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))
- 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))
- 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))
- 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))
研究者
Janice Eng
Professor
University of British Columbia