Clinical trial NCT04947293: Yoga Among Stroke Patients With Chronic Sequelae
Official title: Effects of Yoga in the Rehabilitation of Stroke Patients With Chronic Sequelea: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Lead sponsor: Hopital La Musse
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional Balance
timeFrame: Baseline
measure: Functional Balance
timeFrame: Immediately after the intervention
measure: Functional Balance
timeFrame: 3 months follow-up
Secondary outcomes:
measure: Functional mobility
timeFrame: Baseline
measure: Functional mobility
timeFrame: Immediately after the intervention
measure: Functional mobility
timeFrame: 3 months follow-up
measure: Gait performance
timeFrame: Baseline
measure: Gait performance
timeFrame: Immediately after the intervention
measure: Gait performance
timeFrame: 3 months follow-up
measure: Maximum isometric muscle strength of the knee extensors
timeFrame: Baseline
measure: Maximum isometric muscle strength of the knee extensors
timeFrame: Immediately after the intervention
measure: Maximum isometric muscle strength of the knee extensors
timeFrame: 3 months follow-up
measure: Activities-specific Balance Confidence Scale - Simplified
timeFrame: Baseline
measure: Activities-specific Balance Confidence Scale - Simplified
timeFrame: Immediately after the intervention
measure: Activities-specific Balance Confidence Scale - Simplified
timeFrame: 3 months follow-up
measure: State Trait Anxiety Inventory
timeFrame: Baseline
measure: State Trait Anxiety Inventory
timeFrame: Immediately after the intervention
measure: State Trait Anxiety Inventory
timeFrame: 3 months follow-up
measure: Beck Depression Inventory
timeFrame: Baseline
measure: Beck Depression Inventory
timeFrame: Immediately after the intervention
measure: Beck Depression Inventory
timeFrame: 3 months follow-up
measure: Reintegration to Normal Living Index
timeFrame: Baseline
measure: Reintegration to Normal Living Index
timeFrame: Immediately after the intervention
measure: Reintegration to Normal Living Index
timeFrame: 3 months follow-up
measure: Compliance during the program
timeFrame: During the intervention
measure: Compliance after the program
timeFrame: 3 months follow-up
Other outcomes:
Locations:
city: Broglie
country: France
facility: City hall of Broglie
state: Eure
city: Corneville sur Risle
country: France
facility: City Hall of Corneville sur Risle
city: Saint-Sébastien-de-Morsent
country: France
facility: Hopital La Musse
Study officials:
affiliation: Hôpital La Musse
name: Maxime Gilliaux, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.