Virtual Physical Activity Seated Exercise - Phase 2 (V-PASE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Stroke, Ischemic; Stroke Hemorrhagic; Chronic Stroke
• Intervention / Treatment: Other: Virtual Physical Activity Seated Exercises (V-PASE)

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chihya Hung, MScPT; Phone Number: 1-604-714-4117; Email: chihya.hung@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 2G9
      • Recruiting
      • GF Strong Rehabilitation Centre
      • Contact: Chihya Hung, MSc; Phone Number: 604-714-4117; Email: chihya.hung@ubc.ca
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Recruiting
      • University of Manitoba
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Recruiting
      • Nova Scotia Health
  • Ontario
    • London, Ontario, Canada
      • Recruiting
      • Western University
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada
      • Recruiting
      • University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10-week group; 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); 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.
No Intervention: Delayed 2-week group (Boot Camp); The Boot Camp group will complete a 2-week seated exercise program following the 10-week active trial period.

What is the study measuring?

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)
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)
30 Second Sit-to-Stand	Assessment of balance and lower extremity strength.	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)
Glucose (HbA1c)	Blood samples will be collected following a 12-hour over-night fast	Immediately post-intervention, and retention (2-months post-intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility Indicator: Compliance	Percentage of participants that attend exercise sessions.	Through study completion (approximately 10 weeks)
Feasibility Indicator: Safety	Number of adverse events that occur during assessments or exercise sessions.	Through study completion (approximately 10 weeks)

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Canadian Institutes of Health Research (CIHR); Michael Smith Foundation for Health Research

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Balance; Stroke; Randomized Controlled Trial; Mobility; Cardiometabolic health; Seated Exercise
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Hemorrhagic Stroke; Stroke
• Other Study ID Numbers: H22-02549

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No