Yoga Among Stroke Patients With Chronic Sequelae

NCT ID: NCT04947293

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-21
• Study Completion Date: 2022-09-30

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.

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.

Conditions

Chronic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Yoga Exercise

Subjects in the experimental group will be invited to participate in 60-minute yoga sessions twice a week for 12 weeks. Each session will include postural (asanas), breathing (pranayama), and meditative exercises. They will be adapted to the physical possibilities of the patients with the help of accessories such as chairs, straps, blankets, blocks. One additional session (60 minutes) per week, in autonomy, at home, will be recommended and accompanied by a video support.

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: OTHER

Both groups will practice a physical activity adapted to their motor skills. They will have two group sessions (maximum 5 people per group) in a face-to-face setting, and one independent session at home supported by a video, each week. These programs last 12 weeks, and will be supervised by the same person, a physiotherapist.

Fitness and mobility exercise

Subjects in the control group will be invited to participate in more conventional exercise sessions, based on a fitness and mobility exercise (FAME) program, 60-minute per sessions twice a week for 12 weeks. One additional session (60 minutes) per week, in autonomy, at home, will be recommended and accompanied by a video support. The effectiveness of this program has already been demonstrated in previous studies.

Group Type: ACTIVE_COMPARATOR

Physical activity

Intervention Type: OTHER

Both groups will practice a physical activity adapted to their motor skills. They will have two group sessions (maximum 5 people per group) in a face-to-face setting, and one independent session at home supported by a video, each week. These programs last 12 weeks, and will be supervised by the same person, a physiotherapist.

Interventions

Physical activity

Both groups will practice a physical activity adapted to their motor skills. They will have two group sessions (maximum 5 people per group) in a face-to-face setting, and one independent session at home supported by a video, each week. These programs last 12 weeks, and will be supervised by the same person, a physiotherapist.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital La Musse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maxime Gilliaux, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital La Musse

Locations

City hall of Broglie

Broglie, Eure, France

City Hall of Corneville sur Risle

Corneville-sur-Risle, , France

Hopital La Musse

Saint-Sébastien-de-Morsent, , France

Countries

France

References

Green E, Huynh A, Broussard L, Zunker B, Matthews J, Hilton CL, Aranha K. Systematic Review of Yoga and Balance: Effect on Adults With Neuromuscular Impairment. Am J Occup Ther. 2019 Jan/Feb;73(1):7301205150p1-7301205150p11. doi: 10.5014/ajot.2019.028944.

Reference Type: BACKGROUND

PMID: 30839270 (View on PubMed)

Thayabaranathan T, Andrew NE, Immink MA, Hillier S, Stevens P, Stolwyk R, Kilkenny M, Cadilhac DA. Determining the potential benefits of yoga in chronic stroke care: a systematic review and meta-analysis. Top Stroke Rehabil. 2017 May;24(4):279-287. doi: 10.1080/10749357.2016.1277481. Epub 2017 Jan 19.

Reference Type: BACKGROUND

PMID: 28100160 (View on PubMed)

Edwards MK, Loprinzi PD. Comparative effects of meditation and exercise on physical and psychosocial health outcomes: a review of randomized controlled trials. Postgrad Med. 2018 Mar;130(2):222-228. doi: 10.1080/00325481.2018.1409049. Epub 2017 Nov 27.

Reference Type: BACKGROUND

PMID: 29164993 (View on PubMed)

Other Identifiers

2020-A03408-31

Identifier Type: -

Identifier Source: org_study_id