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NCT Number: NCT05724823

Virtual Physical Activity Seated Exercise - Phase 2

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Stroke Hemorrhagic Stroke Ischemic Stroke Nervous System Diseases Stroke Hemorrhagic Stroke, Ischemic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GF Strong Rehabilitation Centre, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 30 Second Sit-to-Stand

    Time frame: Immediately post-intervention (following 10-week trial)

    Assessment of balance and lower extremity strength.

Secondary outcomes

  1. Timed Up and Go

    Time frame: Immediately post-intervention, and retention (2-months post-intervention)

    Participants stand up from a chair, walk 3 metres, turn around and then sit back down. The TUG assesses balance, mobility and turning ability

  2. Tandem Stance

    Time frame: Immediately post-intervention, and retention (2-months post-intervention)

    Measures balance in standing as reported in the Short Physical Performance Battery Protocol

  3. Modified Telehealth Fugl-Meyer

    Time frame: Immediately post-intervention, and retention (2-months post-intervention)

    The modified virtual Fugl-Meyer assess lower extremity impairments in those with stroke

  4. Stroke Impact Scale

    Time frame: Immediately post-intervention, and retention (2-months post-intervention)

    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.

  5. Activities-Specific Balance Confidence (ABC)

    Time frame: Immediately post-intervention, and retention (2-months post-intervention)

    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).

  6. Fatigue Severity Scale

    Time frame: Immediately post-intervention, and retention (2-months post-intervention)

    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).

  7. Quality of Life (EQ-5D-5L)

    Time frame: Immediately post-intervention, and retention (2-months post-intervention)

    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).

  8. Patient Health Questionnaire-4 (PHQ-4)

    Time frame: Immediately post-intervention, and retention (2-months post-intervention)

    The PHQ-4 focuses on depression and anxiety. Questions are scored from 0 to 3 (0=not at all; 3 = Nearly every day).

  9. Montreal Cognitive Assessment scale (MoCA-BLIND)

    Time frame: Immediately post-intervention, and retention (2-months post-intervention)

    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).

  10. Lipid Profiles

    Time frame: Immediately post-intervention, and retention (2-months post-intervention)

    Blood samples will be collected following a 12-hour over-night fast

  11. Fasting Glucose

    Time frame: Immediately post-intervention, and retention (2-months post-intervention)

    Blood samples will be collected following a 12-hour over-night fast

  12. Glucose (HbA1c)

    Time frame: Immediately post-intervention, and retention (2-months post-intervention)

    Blood samples will be collected following a 12-hour over-night fast

  13. 30 Second Sit-to-Stand

    Time frame: Retention (2-months post-intervention)

    Assessment of balance and lower extremity strength.

Other outcomes

  1. Feasibility Indicator: Compliance

    Time frame: Through study completion (approximately 10 weeks)

    Percentage of participants that attend exercise sessions.

  2. Feasibility Indicator: Safety

    Time frame: Through study completion (approximately 10 weeks)

    Number of adverse events that occur during assessments or exercise sessions.

Study contacts

Contact information is provided by the study sponsor or research team.

Chihya Hung, MScPT

CONTACT

[email protected]

1-604-714-4117

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Michael Smith Foundation for Health Research

Registry information

Official study title

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

Acronym: V-PASE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2023
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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