Virtuele fysieke activiteit Zittende oefening - Fase 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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 2G9
- GF Strong Rehabilitation Centre
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Manitoba
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Winnipeg, Manitoba, Canada
- University of Manitoba
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Nova Scotia
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Halifax, Nova Scotia, Canada
- Nova Scotia Health
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Ontario
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London, Ontario, Canada
- Western University
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Saskatchewan
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Saskatoon, Saskatchewan, Canada
- University of Saskatchewan
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 10-week group
Will receive a 10-week seated exercise program, occurring 3 times per week. Sessions will be 60 minutes in duration. |
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. |
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Geen tussenkomst: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
30 Second Sit-to-Stand
Tijdsspanne: Immediately post-intervention (following 10-week trial)
|
Assessment of balance and lower extremity strength. |
Immediately post-intervention (following 10-week trial)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Timed Up and Go
Tijdsspanne: 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 |
Immediately post-intervention, and retention (2-months post-intervention)
|
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Tandem Stance
Tijdsspanne: Immediately post-intervention, and retention (2-months post-intervention)
|
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
Tijdsspanne: Immediately post-intervention, and retention (2-months post-intervention)
|
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
Tijdsspanne: 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. |
Immediately post-intervention, and retention (2-months post-intervention)
|
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Activities-Specific Balance Confidence (ABC)
Tijdsspanne: 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). |
Immediately post-intervention, and retention (2-months post-intervention)
|
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Fatigue Severity Scale
Tijdsspanne: 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). |
Immediately post-intervention, and retention (2-months post-intervention)
|
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Quality of Life (EQ-5D-5L)
Tijdsspanne: 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). |
Immediately post-intervention, and retention (2-months post-intervention)
|
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Patient Health Questionnaire-4 (PHQ-4)
Tijdsspanne: 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). |
Immediately post-intervention, and retention (2-months post-intervention)
|
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Montreal Cognitive Assessment scale (MoCA-BLIND)
Tijdsspanne: 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). |
Immediately post-intervention, and retention (2-months post-intervention)
|
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Lipid Profiles
Tijdsspanne: Immediately post-intervention, and retention (2-months post-intervention)
|
Blood samples will be collected following a 12-hour over-night fast |
Immediately post-intervention, and retention (2-months post-intervention)
|
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Fasting Glucose
Tijdsspanne: Immediately post-intervention, and retention (2-months post-intervention)
|
Blood samples will be collected following a 12-hour over-night fast |
Immediately post-intervention, and retention (2-months post-intervention)
|
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Glucose (HbA1c)
Tijdsspanne: Immediately post-intervention, and retention (2-months post-intervention)
|
Blood samples will be collected following a 12-hour over-night fast |
Immediately post-intervention, and retention (2-months post-intervention)
|
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30 Second Sit-to-Stand
Tijdsspanne: Retention (2-months post-intervention)
|
Assessment of balance and lower extremity strength. |
Retention (2-months post-intervention)
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Feasibility Indicator: Compliance
Tijdsspanne: Through study completion (approximately 10 weeks)
|
Percentage of participants that attend exercise sessions. |
Through study completion (approximately 10 weeks)
|
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Feasibility Indicator: Safety
Tijdsspanne: Through study completion (approximately 10 weeks)
|
Number of adverse events that occur during assessments or exercise sessions. |
Through study completion (approximately 10 weeks)
|
Medewerkers en onderzoekers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- H22-02549
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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