YOGA-FIT: Protocol for a Crossover Trial Investigating the Feasibility and Impact of Yoga for People With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Safety -Serious Adverse Events
研究概览
简要总结
The primary objective of this mixed-methods pilot crossover study is to determine the feasibility (participant satisfaction, recruitment rate, retention, 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 cognition, fatigue, and health-related quality of life change following the LYB program.
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
In-person LoveYourBrain Yoga
Participants will engage in a 90-minute in-person class that will consist of 10 minutes of breathing, 45 minutes of Yoga postures, 15 minutes of meditation, and 20 minutes of psychoeducation and discussion. Additionally, participants will complete a 45- to 60-minute recorded class on their own time.
干预措施: LoveYourBrain Yoga (Behavioral)
Virtual LoveYourBrain Yoga
Participants will engage in a 90-minute virtual class that will consist of 10 minutes of breathing, 45 minutes of Yoga postures, 15 minutes of meditation, and 20 minutes of psychoeducation and discussion. Additionally, participants will complete a 45- to 60-minute recorded class on their own time.
干预措施: LoveYourBrain Yoga (Behavioral)
结局指标
主要结局
Safety -Serious Adverse Events
时间窗: Monitoring during each class (weeks 1-24) and at all 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)
Serious adverse events related to the study
Recruitment rate
时间窗: Baseline
Percentage of eligible stroke survivors approached and agree to participate.
Participant satisfaction
时间窗: Weekly satisfaction questionnaire (weeks 1-24) via smartphone app
Satisfaction questionnaire
Participant and assessor burden
时间窗: During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)
Assessment time
Adherence
时间窗: Weeks 1-24
Class attendance- Weekly surveys via smartphone app and yoga instructor tracking
Equipment
时间窗: Weeks 1-24 and interviews at the end of 24 weeks
Technical issues during virtual classes- Yoga instructor tracking during each class and interviews at the end of the study
Smartphone application
时间窗: Weeks 1-24 and interviews at the end of 24 weeks
Issues with smartphone application-Weekly smartphone surveys and interviews at the end of the study
Participant retention
时间窗: Weeks 1-24
Percentage of of participants who complete the LYB program
Recruitment rate
时间窗: Baseline
Percentage of eligible stroke survivors approached and agree to participate.
Participant satisfaction
时间窗: Weekly satisfaction questionnaire (weeks 1-24) via smartphone app
Satisfaction questionnaire
Adherence
时间窗: Weeks 1-24
Class attendance- Weekly surveys via smartphone app and yoga instructor tracking
Participant and assessor burden
时间窗: During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)
Assessment time
Smartphone application
时间窗: Weeks 1-24 and interviews at the end of 24 weeks
Issues with smartphone application-Weekly smartphone surveys and interviews at the end of the study
Equipment
时间窗: Weeks 1-24 and interviews at the end of 24 weeks
Technical issues during virtual classes- Yoga instructor tracking during each class and interviews at the end of the study
Safety -Serious Adverse Events
时间窗: Monitoring during each class (weeks 1-24) and at all 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)
Serious adverse events related to the study
次要结局
- Balance(During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks))
- Walking(During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks))
- Mobility(During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks))
- Health outcomes(Weekly surveys via smartphone app)
- Mental health(During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks))
- Balance(During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks))
- Walking(During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks))
- Mobility(During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks))
- Mental health(During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks))
- Health outcomes(Weekly surveys via smartphone app)
研究者
Adria Quigley
Assistant Professor
Dalhousie University