Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-27 @ 11:57 AM
Study NCT ID:
NCT04947293
Status:
COMPLETED
Last Update Posted:
2023-03-09
First Post:
2021-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yoga Among Stroke Patients With Chronic Sequelae
Sponsor:
Hopital La Musse
Organization:
Study Overview
Official Title:
Effects of Yoga in the Rehabilitation of Stroke Patients With Chronic Sequelea: A Randomized Controlled Trial.
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: