Effects of Yoga in the Rehabilitation of Stroke Patients With Chronic Sequelea: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Functional Balance
研究概览
简要总结
Stroke is a major health problem and can cause long-term disability. Among these sequelae, there are balance and mobility disorders, but also a higher rate of anxiety or depression disorders. This impairments impact activity of daily living, and social reintegration. That why the investigators need to explore options for long-term sustainable interventions that which takes into account the patient as a whole. In particular, regular physical activity is recommended, but it must be adaptable to the patient's impairments. Teaching yoga may be an interesting option. Indeed, yoga is a mind-body practice which become increasingly widespread in the world. Recent studies highlight positive effect of yoga for this population. However, the levels of evidence are limited, and new studies are needed.
Primary objective of the study is to demonstrate the non-inferiority of a therapeutic yoga program, compared to a conventional physical activity program, to improve balance of patients with chronic stroke sequelae.
Secondary objectives are to demonstrate the non-inferiority of the therapeutic yoga program in improving muscle strength and functional mobility, as well as its superiority in improving anxiety, depression, social reintegration and adherence to treatment.
详细描述
The investigators will conduct a single-blind randomised controlled trial to study the effectiveness of a yoga programme compared to a conventional adapted physical activity programme in improving balance in chronic post-stroke subjects. The primary hypothesis is that yoga is non-inferior to conventional physical activity in improving balance in chronic post-stroke patients. The secondary hypothesis is that yoga is non-inferior to conventional physical activity in improving muscle strength and functional mobility, but superior in improving anxiety, depression, social reintegration and treatment adherence.
The experiment will take place in Normandy (France), at several sites in order to maximise recruitment and minimise travel for participants. The statistical power study indicates that 42 patients per group would be required. Subjects will be randomly assigned to one of the following programmes: the YOG'AVC programme or the FAME programme. The first will involve yoga sessions with postural, respiratory, and meditative work. The second will involve more conventional exercise sessions, based on a Fitness and Mobility Exercise Program (FAME) designed for stroke survivors. Both programmes included two 60-minute group sessions per week, for 12 weeks, plus one weekly home-based session (with video or paper support). Patients will be assessed at three points in the study: before the experiment (T0), after the 12-week experiment (T1), and 3 months later (T2). The assessments will be carried out blind, using a protocol built around the International Classification of Functioning and Disability (ICF). The main criterion is balance, assessed by the Berg balance scale (0-56 point scale). The secondary outcomes will be assessed by: Timed Up and Go Test (timed task in seconds), 6-minute walk test (distance covered in meters), maximum isometric knee extension force with a manual dynamometer (newton), the activities-specific Balance Confidence Scale - Simplified (questionnaire in %), State-Trait Anxiety Inventory (2 questionnaires out of 80), Beck Depression Inventory (score out of 63), Reintegration to Normal Living Index (score out of 100). Adherence to the programme will be assessed by a logbook, between T0 and T1 by the number of group and individual sessions completed, and between T1 and T2 by the number of self-reported sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •a minimum of six month elapsed time since stroke incidence
- •present balance disorders (score between 21 and 51 on the Berg Balance Scale)
- •ability to stand and walk at least 10 metres (with or without an assistance device)
- •be affiliated to a social security system
排除标准
- •under 18 years of age
- •cognitive impairment assessed by a score of less than 4 on the 6-items Mini-Mental State Examination
- •inability to understand the French language (to the point of not being able to answer questionnaires, or understand instruction)
- •medical contraindication to the practice of a sport activity
- •current and regular participation in a physical activity program
- •Being deprived of liberty by a judicial or administrative decision,
- •Receive psychiatric care,
- •Be subject to a legal protection measure (guardianship, curatorship and safeguarding of justice),
- •Being a pregnant, parturient or breastfeeding woman
结局指标
主要结局
Functional Balance
时间窗: 3 months follow-up
Berg Balance Scale : This test is used to quantitatively assess balance in older adults. In this 14-item scale, patients are asked to maintain positions and perform movement tasks of varying degrees of difficulty. Patients receive a score between 0 and 4 on their ability to respond to dimensions of balance. An overall score can be calculated from a total of 56. The higher the score, the better the balance. This scale has been found to be reliable, valid, and is the most commonly used clinical and research scale for assessing balance in stroke patients.
次要结局
- Compliance during the program(During the intervention)
- Gait performance(3 months follow-up)
- Activities-specific Balance Confidence Scale - Simplified(3 months follow-up)
- Functional mobility(3 months follow-up)
- State Trait Anxiety Inventory(3 months follow-up)
- Beck Depression Inventory(3 months follow-up)
- Reintegration to Normal Living Index(3 months follow-up)
- Maximum isometric muscle strength of the knee extensors(3 months follow-up)
- Compliance after the program(3 months follow-up)