Virtual Physical Activity Seated Exercise - Phase 2 - Clinical Trial for Stroke | NCT05724823

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Virtual Physical Activity Seated Exercises (V-PASE)

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Seated Exercise, Balance, Mobility, Cardiometabolic health, Randomized Controlled Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

GF Strong Rehabilitation Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

10-week group

Delayed 2-week group (Boot Camp)

Arm Description

Will receive a 10-week seated exercise program, occurring 3 times per week. Sessions will be 60 minutes in duration.

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

Outcomes

Primary Outcome Measures

30 Second Sit-to-Stand

Assessment of balance and lower extremity strength.

Secondary Outcome Measures

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

Tandem Stance

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

Modified Telehealth Fugl-Meyer

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

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.

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).

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).

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).

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).

Lipid Profiles

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

Fasting Glucose

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

30 Second Sit-to-Stand

Assessment of balance and lower extremity strength.

Full Information

NCT ID

NCT05724823

First Posted

January 17, 2023

Last Updated

July 21, 2023

Sponsor

University of British Columbia

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05724823

Brief Title

Virtual Physical Activity Seated Exercise - Phase 2

Acronym

V-PASE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 2023 (Anticipated)

Primary Completion Date

December 2026 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Chronic Stroke, Stroke, Ischemic, Stroke Hemorrhagic

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

10-week group

Arm Type

Experimental

Arm Description

Will receive a 10-week seated exercise program, occurring 3 times per week. Sessions will be 60 minutes in duration.

Arm Title

Delayed 2-week group (Boot Camp)

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Virtual Physical Activity Seated Exercises (V-PASE)

Intervention Description

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 Outcome Measure Information:

Title

30 Second Sit-to-Stand

Description

Assessment of balance and lower extremity strength.

Time Frame

Immediately post-intervention (following 10-week trial)

Secondary Outcome Measure Information:

Title

Timed Up and Go

Description

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

Time Frame