Clinical trial NCT05724823: Virtual Physical Activity Seated Exercise - Phase 2
Official title: Assessing a Telehealth Seated Exercise Program on Post-stroke Balance and Mobility: a Mixed-method Design
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Chronic Stroke
Stroke, Ischemic
Stroke Hemorrhagic
Keywords: Stroke
Seated Exercise
Balance
Mobility
Cardiometabolic health
Randomized Controlled Trial
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Michael Smith Foundation for Health Research
First posted: 2023-02-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 30 Second Sit-to-Stand
timeFrame: Immediately post-intervention (following 10-week trial)
Secondary outcomes:
measure: Timed Up and Go
timeFrame: Immediately post-intervention, and retention (2-months post-intervention)
measure: Tandem Stance
timeFrame: Immediately post-intervention, and retention (2-months post-intervention)
measure: Modified Telehealth Fugl-Meyer
timeFrame: Immediately post-intervention, and retention (2-months post-intervention)
measure: Stroke Impact Scale
timeFrame: Immediately post-intervention, and retention (2-months post-intervention)
measure: Activities-Specific Balance Confidence (ABC)
timeFrame: Immediately post-intervention, and retention (2-months post-intervention)
measure: Fatigue Severity Scale
timeFrame: Immediately post-intervention, and retention (2-months post-intervention)
measure: Quality of Life (EQ-5D-5L)
timeFrame: Immediately post-intervention, and retention (2-months post-intervention)
measure: Patient Health Questionnaire-4 (PHQ-4)
timeFrame: Immediately post-intervention, and retention (2-months post-intervention)
measure: Montreal Cognitive Assessment scale (MoCA-BLIND)
timeFrame: Immediately post-intervention, and retention (2-months post-intervention)
measure: Lipid Profiles
timeFrame: Immediately post-intervention, and retention (2-months post-intervention)
measure: Fasting Glucose
timeFrame: Immediately post-intervention, and retention (2-months post-intervention)
measure: Glucose (HbA1c)
timeFrame: Immediately post-intervention, and retention (2-months post-intervention)
measure: 30 Second Sit-to-Stand
timeFrame: Retention (2-months post-intervention)
Other outcomes:
measure: Feasibility Indicator: Compliance
timeFrame: Through study completion (approximately 10 weeks)
measure: Feasibility Indicator: Safety
timeFrame: Through study completion (approximately 10 weeks)
Locations:
city: Vancouver
country: Canada
facility: GF Strong Rehabilitation Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Nova Scotia Health
state: Nova Scotia
city: London
country: Canada
facility: Western University
state: Ontario
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
References: