YOGA-FIT: Protocol for a Crossover Trial Investigating the Feasibility and Impact of Yoga for People With Stroke

Обзор

The primary objective of this mixed-methods pilot crossover study is to determine the feasibility (participant satisfaction, recruitment rate, participant and assessor burden, adherence, equipment and technology issues, and safety) of virtual and in-person LYB yoga for adult people with lived experience of stroke in Nova Scotia who are at least three months post stroke. The secondary objective is to estimate the efficacy of virtual and in-person yoga for improving balance, walking, mobility, mental health (anxiety and depression), and other health outcomes (pain, sleep, health perception, and falls). The tertiary objective is to estimate the extent to which cognitive function, fatigue, and health-related quality of life co-evolve with our secondary outcomes. Participants will engage in LYB Yoga virtual and in-person classes for 90 minutes each, twice per week, as well as one 60-minute recorded class completed on their own time.

Подробное описание

LoveYourBrain (LYB) is a six-week manualized Yoga program that was originally developed for traumatic brain injury (TBI) patients. The sessions involve meditation, breathing, a variety of Yoga postures, and psychoeducation and discussion components. The program contains key aspects of neuroplasticity and motor learning, which are essential for promoting stroke recovery.

This program can be adapted to suit the needs of the subacute and chronic stroke survivor population: adjusting postures to allow for people with stroke to participate, as well as a variety of seated and standing options will be made available in the LYB Yoga program. This program will also involve group discussion, educational activities, and coping strategies to help with stroke recovery, while creating a sense of community and mutual understanding.

The program has not yet been offered in the stroke context, nor is it available across Nova Scotia. Therefore, the main aim of this study is to test the feasibility of adapting LYB for the stroke context and making it widely available across Nova Scotia in a virtual and in-person format.

Вмешательства

• Поведенческое LoveYourBrain Yoga
  The LoveYourBrain Yoga program consists of various techniques, including: breathing, Yoga postures, meditation, and psychoeducation as well as a group discussion.

Первичные конечные точки

• Recruitment rate [Срок оценки: Baseline]
• Participant satisfaction [Срок оценки: Weekly satisfaction questionnaire (weeks 1-24) via smartphone app]
• Participant and assessor burden [Срок оценки: During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)]
• Adherence [Срок оценки: Weeks 1-24]
• Equipment [Срок оценки: Weeks 1-24 and interviews at the end of 24 weeks]
• Smartphone application [Срок оценки: Weeks 1-24 and interviews at the end of 24 weeks]
• Safety -Serious Adverse Events [Срок оценки: Monitoring during each class (weeks 1-24) and at all 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)]

Вторичные конечные точки (6)

• Balance [Срок оценки: During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)]
• Walking [Срок оценки: During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)]
• Mobility [Срок оценки: During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)]
• Mental health [Срок оценки: During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)]
• Mental health [Срок оценки: During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)]
• Health outcomes [Срок оценки: Weekly surveys via smartphone app]

Критерии участия

Критерии включения

Participants will be eligible if they are an adult (aged 18 or older), living with late subacute or chronic stroke (minimum of three months post stroke), residing in Nova Scotia, capable of walking at least 10-metres independently, with supervision, or with the use of an aid or orthotic, and medically stable for eight weeks prior to the baseline visit. Participants must also be able to follow a three-step command for the purpose of yoga class instruction as recommended by our lead yoga instructor.

Критерии исключения

Participants with severe neglect or other issues affecting their safety and participation will be excluded. Participants with cardiovascular, orthopedic, or neurological diseases other than stroke, impacting walking, balance, and mobility will be excluded. Participants who do not have a stable and reliable internet connection will be excluded.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• NeuroCommons — Halifax

Идентификаторы

NCT: NCT07143162 · YOGA-FIT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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