Virtual Physical Activity Seated Exercise - Phase 2

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Virtual Physical Activity Seated Exercises (V-PASE)
  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.

Первичные конечные точки

• 30 Second Sit-to-Stand [Срок оценки: Immediately post-intervention (following 10-week trial)]

Вторичные конечные точки (12)

• Timed Up and Go [Срок оценки: Immediately post-intervention, and retention (2-months post-intervention)]
• Tandem Stance [Срок оценки: Immediately post-intervention, and retention (2-months post-intervention)]
• Modified Telehealth Fugl-Meyer [Срок оценки: Immediately post-intervention, and retention (2-months post-intervention)]
• Stroke Impact Scale [Срок оценки: Immediately post-intervention, and retention (2-months post-intervention)]
• Activities-Specific Balance Confidence (ABC) [Срок оценки: Immediately post-intervention, and retention (2-months post-intervention)]
• Fatigue Severity Scale [Срок оценки: Immediately post-intervention, and retention (2-months post-intervention)]
• Quality of Life (EQ-5D-5L) [Срок оценки: Immediately post-intervention, and retention (2-months post-intervention)]
• Patient Health Questionnaire-4 (PHQ-4) [Срок оценки: Immediately post-intervention, and retention (2-months post-intervention)]
• Montreal Cognitive Assessment scale (MoCA-BLIND) [Срок оценки: Immediately post-intervention, and retention (2-months post-intervention)]
• Lipid Profiles [Срок оценки: Immediately post-intervention, and retention (2-months post-intervention)]
• Fasting Glucose [Срок оценки: Immediately post-intervention, and retention (2-months post-intervention)]
• Glucose (HbA1c) [Срок оценки: Immediately post-intervention, and retention (2-months post-intervention)]

Критерии участия

Критерии включения

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

Критерии исключения

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 5 центров

• GF Strong Rehabilitation Centre — Vancouver
• University of Manitoba — Winnipeg
• Nova Scotia Health — Halifax
• Western University — London
• University of Saskatchewan — Saskatoon

Публикации

• Mackie P, Ashe MC, Barclay R, Bayley MT, Donkers SJ, Fleet JL, Mortenson WB, Peters S, Pollock CL, Pooyania S, Quigley A, Sakakibara BM, Schneeberg A, Sheehy L, Stelling S, Yao J, Eng JJ. Transferability of a 10-week remotely delivered Virtual Physical Activity Seated Exercise (V-PASE) program on post-stroke functional mobility: study protocol for a multisite randomized controlled trial. Trials. 2 PMID 41645237

Идентификаторы

NCT: NCT05724823 · H22-02549

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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