Virtual Physical Activity Seated Exercise - Phase 2

Stroke Clinical Trial

— V-PASE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05724823
• Other study ID #: H22-02549
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2023
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: University of British Columbia
• Contact: Chihya Hung, MScPT
• Phone: 1-604-714-4117
• Email: chihya.hung[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Stroke
• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic

Intervention

Other:
• Virtual 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.

Locations

Country	Name	City	State
Canada	GF Strong Rehabilitation Centre	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR), Michael Smith Foundation for Health Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility Indicator: Compliance	Percentage of participants that attend exercise sessions.	Through study completion (approximately 10 weeks)
Other	Feasibility Indicator: Safety	Number of adverse events that occur during assessments or exercise sessions.	Through study completion (approximately 10 weeks)
Primary	30 Second Sit-to-Stand	Assessment of balance and lower extremity strength.	Immediately post-intervention (following 10-week trial)
Secondary	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)
Secondary	Tandem Stance	Measures balance in standing as reported in the Short Physical Performance Battery Protocol	Immediately post-intervention, and retention (2-months post-intervention)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Lipid Profiles	Blood samples will be collected following a 12-hour over-night fast	Immediately post-intervention, and retention (2-months post-intervention)
Secondary	Fasting Glucose	Blood samples will be collected following a 12-hour over-night fast	Immediately post-intervention, and retention (2-months post-intervention)
Secondary	Glucose (HbA1c)	Blood samples will be collected following a 12-hour over-night fast	Immediately post-intervention, and retention (2-months post-intervention)
Secondary	30 Second Sit-to-Stand	Assessment of balance and lower extremity strength.	Retention (2-months post-intervention)