Wirtualna aktywność fizyczna Ćwiczenia na siedząco — faza 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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
British Columbia
-
Vancouver, British Columbia, Kanada, V5Z 2G9
- GF Strong Rehabilitation Centre
-
-
Manitoba
-
Winnipeg, Manitoba, Kanada
- University of Manitoba
-
-
Nova Scotia
-
Halifax, Nova Scotia, Kanada
- Nova Scotia Health
-
-
Ontario
-
London, Ontario, Kanada
- Western University
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Kanada
- University of Saskatchewan
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
|
Brak interwencji: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
30 Second Sit-to-Stand
Ramy czasowe: Immediately post-intervention (following 10-week trial)
|
Assessment of balance and lower extremity strength. |
Immediately post-intervention (following 10-week trial)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Timed Up and Go
Ramy czasowe: 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)
|
|
Tandem Stance
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
|
|
Activities-Specific Balance Confidence (ABC)
Ramy czasowe: 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)
|
|
Fatigue Severity Scale
Ramy czasowe: 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)
|
|
Quality of Life (EQ-5D-5L)
Ramy czasowe: 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)
|
|
Patient Health Questionnaire-4 (PHQ-4)
Ramy czasowe: 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)
|
|
Montreal Cognitive Assessment scale (MoCA-BLIND)
Ramy czasowe: 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)
|
|
Lipid Profiles
Ramy czasowe: 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)
|
|
Fasting Glucose
Ramy czasowe: 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)
|
|
Glucose (HbA1c)
Ramy czasowe: 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)
|
|
30 Second Sit-to-Stand
Ramy czasowe: Retention (2-months post-intervention)
|
Assessment of balance and lower extremity strength. |
Retention (2-months post-intervention)
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Feasibility Indicator: Compliance
Ramy czasowe: Through study completion (approximately 10 weeks)
|
Percentage of participants that attend exercise sessions. |
Through study completion (approximately 10 weeks)
|
|
Feasibility Indicator: Safety
Ramy czasowe: Through study completion (approximately 10 weeks)
|
Number of adverse events that occur during assessments or exercise sessions. |
Through study completion (approximately 10 weeks)
|
Współpracownicy i badacze
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- H22-02549
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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