Virtual Physical Activity Seated Exercise - Phase 2

NCT05724823 | Recruiting

• 1 other identifier: H22-02549
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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.

Conditions

Stroke; Chronic Stroke; Stroke, Ischemic; Stroke Hemorrhagic

Keywords

Stroke; Seated Exercise; Balance; Mobility; Cardiometabolic health; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 30 Second Sit-to-Stand

  Assessment of balance and lower extremity strength.

  Immediately post-intervention (following 10-week trial)

Secondary Outcomes (13)

• 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)

• Stroke Impact Scale

  Immediately post-intervention, and retention (2-months post-intervention)

• Activities-Specific Balance Confidence (ABC)

  Immediately post-intervention, and retention (2-months post-intervention)

Other Outcomes (2)

• Feasibility Indicator: Compliance

  Through study completion (approximately 10 weeks)

• Feasibility Indicator: Safety

  Through study completion (approximately 10 weeks)

Study Arms (2)

10-week group

EXPERIMENTAL

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)

Delayed 2-week group (Boot Camp)

NO INTERVENTION

The Boot Camp group will complete a 2-week seated exercise program following the 10-week active trial period.

Interventions

Virtual Physical Activity Seated Exercises (V-PASE) OTHER

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.

10-week group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Michael Smith Foundation for Health Research: collaborator

Study Sites (5)

GF Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

RECRUITING

University of Manitoba

Winnipeg, Manitoba, Canada

RECRUITING

Nova Scotia Health

Halifax, Nova Scotia, Canada

RECRUITING

Western University

London, Ontario, Canada

RECRUITING

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Chihya Hung, MScPT

CONTACT

1-604-714-4117; chihya.hung@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 13, 2023
• Study Start: October 11, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)