- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04947293
Yoga Among Stroke Patients With Chronic Sequelae
Effects of Yoga in the Rehabilitation of Stroke Patients With Chronic Sequelea: A Randomized Controlled Trial.
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rita Lenoir dit caron, PhD Student
- Phone Number: +33 786917877
- Email: rita.lenoir@hotmail.fr
Study Locations
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Corneville sur Risle, France, 27500
- City Hall of Corneville sur Risle
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Saint-Sébastien-de-Morsent, France, 27180
- Hôpital La Musse
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Eure
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Broglie, Eure, France, 27270
- City hall of Broglie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
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Active Comparator: 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Balance
Time Frame: Baseline
|
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.
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Baseline
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Functional Balance
Time Frame: Immediately after the intervention
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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.
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Immediately after the intervention
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Functional Balance
Time Frame: 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.
|
3 months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional mobility
Time Frame: Baseline
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Timed Up and Go Test : It is a test based on the performance of a functional task, where the subject must get up from a chair, walk 3 meters, turn around and return to a seat.
The subject is timed during the execution and a score in seconds is established.
The reliability and validity of this test was established in a chronic stroke population.
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Baseline
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Functional mobility
Time Frame: Immediately after the intervention
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Timed Up and Go Test : It is a test based on the performance of a functional task, where the subject must get up from a chair, walk 3 meters, turn around and return to a seat.
The subject is timed during the execution and a score in seconds is established.
The reliability and validity of this test was established in a chronic stroke population.
|
Immediately after the intervention
|
Functional mobility
Time Frame: 3 months follow-up
|
Timed Up and Go Test : It is a test based on the performance of a functional task, where the subject must get up from a chair, walk 3 meters, turn around and return to a seat.
The subject is timed during the execution and a score in seconds is established.
The reliability and validity of this test was established in a chronic stroke population.
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3 months follow-up
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Gait performance
Time Frame: Baseline
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The 6-minute walk test (TDM6) : an endurance test where the subject must walk for 6 minutes over the longest possible distance (score in meters).
This test is reliable and valid for a chronic stroke population.
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Baseline
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Gait performance
Time Frame: Immediately after the intervention
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The 6-minute walk test (TDM6) : an endurance test where the subject must walk for 6 minutes over the longest possible distance (score in meters).
This test is reliable and valid for a chronic stroke population.
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Immediately after the intervention
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Gait performance
Time Frame: 3 months follow-up
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The 6-minute walk test (TDM6) : an endurance test where the subject must walk for 6 minutes over the longest possible distance (score in meters).
This test is reliable and valid for a chronic stroke population.
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3 months follow-up
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Maximum isometric muscle strength of the knee extensors
Time Frame: Baseline
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Manual dynamometer (Microfet2®).
Subject is seated, knees and hips bent at 90°.
The dynamometer is placed on the anterior surface of the tibia, 5 cm from the malleoli, with a tip adapted to the surface being tested.
The subject is invited to push against the resistance, as if stretching the leg, with all the force he or she can muster.
The measurement is repeated 3 times, and the score (in Newton) is established by averaging the 3 trials.
Hand-held dynamometry is a reliable and valid method for assessing muscle strength in a stroke population.
|
Baseline
|
Maximum isometric muscle strength of the knee extensors
Time Frame: Immediately after the intervention
|
Manual dynamometer (Microfet2®).
Subject is seated, knees and hips bent at 90°.
The dynamometer is placed on the anterior surface of the tibia, 5 cm from the malleoli, with a tip adapted to the surface being tested.
The subject is invited to push against the resistance, as if stretching the leg, with all the force he or she can muster.
The measurement is repeated 3 times, and the score (in Newton) is established by averaging the 3 trials.
Hand-held dynamometry is a reliable and valid method for assessing muscle strength in a stroke population.
|
Immediately after the intervention
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Maximum isometric muscle strength of the knee extensors
Time Frame: 3 months follow-up
|
Manual dynamometer (Microfet2®).
Subject is seated, knees and hips bent at 90°.
The dynamometer is placed on the anterior surface of the tibia, 5 cm from the malleoli, with a tip adapted to the surface being tested.
The subject is invited to push against the resistance, as if stretching the leg, with all the force he or she can muster.
The measurement is repeated 3 times, and the score (in Newton) is established by averaging the 3 trials.
Hand-held dynamometry is a reliable and valid method for assessing muscle strength in a stroke population.
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3 months follow-up
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Activities-specific Balance Confidence Scale - Simplified
Time Frame: Baseline
|
This questionnaire consists of 16 questions that require the patient to assess his or her confidence that he or she will not lose balance while performing the cited activities.
For each of the 16 activities, the patient is asked to rate their confidence from 0 (not at all confident) to 3 (very confident).
The total score is given as a percentage.
The reliability and validity of the French version of this questionnaire has been established.
|
Baseline
|
Activities-specific Balance Confidence Scale - Simplified
Time Frame: Immediately after the intervention
|
This questionnaire consists of 16 questions that require the patient to assess his or her confidence that he or she will not lose balance while performing the cited activities.
For each of the 16 activities, the patient is asked to rate their confidence from 0 (not at all confident) to 3 (very confident).
The total score is given as a percentage.
The reliability and validity of the French version of this questionnaire has been established.
|
Immediately after the intervention
|
Activities-specific Balance Confidence Scale - Simplified
Time Frame: 3 months follow-up
|
This questionnaire consists of 16 questions that require the patient to assess his or her confidence that he or she will not lose balance while performing the cited activities.
For each of the 16 activities, the patient is asked to rate their confidence from 0 (not at all confident) to 3 (very confident).
The total score is given as a percentage.
The reliability and validity of the French version of this questionnaire has been established.
|
3 months follow-up
|
State Trait Anxiety Inventory
Time Frame: Baseline
|
The 2 forms of the State Trait Anxiety Inventory (STAI, Form Y) will use to measure state anxiety (STAI-Y1) and trait anxiety (STAI-Y2). The 2 forms consist of 20 items each, which are rated on a 4-point Likert-type scale depending on how the participant feels at the moment in time for STAI-Y1 or how the participant feels generally for STAI-Y2. Higher scores are associated with increased symptoms of state or trait anxiety. |
Baseline
|
State Trait Anxiety Inventory
Time Frame: Immediately after the intervention
|
The 2 forms of the State Trait Anxiety Inventory (STAI, Form Y) will use to measure state anxiety (STAI-Y1) and trait anxiety (STAI-Y2). The 2 forms consist of 20 items each, which are rated on a 4-point Likert-type scale depending on how the participant feels at the moment in time for STAI-Y1 or how the participant feels generally for STAI-Y2. Higher scores are associated with increased symptoms of state or trait anxiety. |
Immediately after the intervention
|
State Trait Anxiety Inventory
Time Frame: 3 months follow-up
|
The 2 forms of the State Trait Anxiety Inventory (STAI, Form Y) will use to measure state anxiety (STAI-Y1) and trait anxiety (STAI-Y2). The 2 forms consist of 20 items each, which are rated on a 4-point Likert-type scale depending on how the participant feels at the moment in time for STAI-Y1 or how the participant feels generally for STAI-Y2. Higher scores are associated with increased symptoms of state or trait anxiety. |
3 months follow-up
|
Beck Depression Inventory
Time Frame: Baseline
|
This self-questionnaire includes 21 items identifying symptoms and attitudes associated with depression.
Each item is assessed on a severity scale ranging from 0 to 3, with a total score ranging from 0 to 63.The higher the score, the more severe the depression.
The reliability and validity of the French version of this questionnaire has been established.
|
Baseline
|
Beck Depression Inventory
Time Frame: Immediately after the intervention
|
This self-questionnaire includes 21 items identifying symptoms and attitudes associated with depression.
Each item is assessed on a severity scale ranging from 0 to 3, with a total score ranging from 0 to 63.The higher the score, the more severe the depression.
The reliability and validity of the French version of this questionnaire has been established.
|
Immediately after the intervention
|
Beck Depression Inventory
Time Frame: 3 months follow-up
|
This self-questionnaire includes 21 items identifying symptoms and attitudes associated with depression.
Each item is assessed on a severity scale ranging from 0 to 3, with a total score ranging from 0 to 63.The higher the score, the more severe the depression.
The reliability and validity of the French version of this questionnaire has been established.
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3 months follow-up
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Reintegration to Normal Living Index
Time Frame: Baseline
|
This self-questionnaire was developed to quantitatively assess the degree to which individuals who have experienced a traumatic or disabling illness are able to reintegrate into normal social activities (e.g., recreational activities, movement in the community, and interactions with family and other relationships).
It is composed of 11 declarative statements (e.g.
I move around my home as much as I want), and the patient gives a score between 0 and 2 (yes, partially, no).
The total score is between 0 and 22 points, a high score indicates low reintegration.
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Baseline
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Reintegration to Normal Living Index
Time Frame: Immediately after the intervention
|
This self-questionnaire was developed to quantitatively assess the degree to which individuals who have experienced a traumatic or disabling illness are able to reintegrate into normal social activities (e.g., recreational activities, movement in the community, and interactions with family and other relationships).
It is composed of 11 declarative statements (e.g.
I move around my home as much as I want), and the patient gives a score between 0 and 2 (yes, partially, no).
The total score is between 0 and 22 points, a high score indicates low reintegration.
|
Immediately after the intervention
|
Reintegration to Normal Living Index
Time Frame: 3 months follow-up
|
This self-questionnaire was developed to quantitatively assess the degree to which individuals who have experienced a traumatic or disabling illness are able to reintegrate into normal social activities (e.g., recreational activities, movement in the community, and interactions with family and other relationships).
It is composed of 11 declarative statements (e.g.
I move around my home as much as I want), and the patient gives a score between 0 and 2 (yes, partially, no).
The total score is between 0 and 22 points, a high score indicates low reintegration.
|
3 months follow-up
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Compliance during the program
Time Frame: During the intervention
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A percentage will be established according to the number of sessions actually performed compared to the number of planned sessions.
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During the intervention
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Compliance after the program
Time Frame: 3 months follow-up
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A percentage will be established based on the number of sessions actually completed compared to the number of sessions recommended.
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3 months follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maxime Gilliaux, PhD, Hôpital La Musse
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-A03408-31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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