Yoga Among Stroke Patients With Chronic Sequelae

Chronic Stroke Clinical Trial

Official title:

Effects of Yoga in the Rehabilitation of Stroke Patients With Chronic Sequelea: A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04947293
• Other study ID #: 2020-A03408-31
• Status: Completed
• Phase: N/A
• Start date: August 21, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2023
• Source: Hopital La Musse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	City hall of Broglie	Broglie	Eure
France	City Hall of Corneville sur Risle	Corneville sur Risle
France	Hopital La Musse	Saint-Sébastien-de-Morsent

Sponsors (1)

Lead Sponsor	Collaborator
Hopital La Musse

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Balance	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.	Baseline
Primary	Functional Balance	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.	Immediately after the intervention
Primary	Functional Balance	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	Functional mobility	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.	Baseline
Secondary	Functional mobility	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
Secondary	Functional mobility	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.	3 months follow-up
Secondary	Gait performance	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.	Baseline
Secondary	Gait performance	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.	Immediately after the intervention
Secondary	Gait performance	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.	3 months follow-up
Secondary	Maximum isometric muscle strength of the knee extensors	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
Secondary	Maximum isometric muscle strength of the knee extensors	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
Secondary	Maximum isometric muscle strength of the knee extensors	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.	3 months follow-up
Secondary	Activities-specific Balance Confidence Scale - Simplified	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
Secondary	Activities-specific Balance Confidence Scale - Simplified	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
Secondary	Activities-specific Balance Confidence Scale - Simplified	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
Secondary	State Trait Anxiety Inventory	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
Secondary	State Trait Anxiety Inventory	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
Secondary	State Trait Anxiety Inventory	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
Secondary	Beck Depression Inventory	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
Secondary	Beck Depression Inventory	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
Secondary	Beck Depression Inventory	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.	3 months follow-up
Secondary	Reintegration to Normal Living Index	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.	Baseline
Secondary	Reintegration to Normal Living Index	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
Secondary	Reintegration to Normal Living Index	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
Secondary	Compliance during the program	A percentage will be established according to the number of sessions actually performed compared to the number of planned sessions.	During the intervention
Secondary	Compliance after the program	A percentage will be established based on the number of sessions actually completed compared to the number of sessions recommended.	3 months follow-up