Yoga Among Stroke Patients With Chronic Sequelae

NCT04947293 | Completed

• 1 other identifier: 2020-A03408-31
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (23)

• Functional mobility

  Baseline

• Functional mobility

  Immediately after the intervention

• Functional mobility

  3 months follow-up

• Gait performance

  Baseline

• Gait performance

  Immediately after the intervention

Study Arms (2)

Yoga Exercise

EXPERIMENTAL

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.

Other: Physical activity

Fitness and mobility exercise

ACTIVE COMPARATOR

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.

Other: Physical activity

Interventions

Physical activity 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; Yoga Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital La Musse: lead

Study Sites (3)

City hall of Broglie

Broglie, Eure, 27270, France

Location

City Hall of Corneville sur Risle

Corneville-sur-Risle, 27500, France

Location

Hopital La Musse

Saint-Sébastien-de-Morsent, 27180, France

Location

Related Publications (3)

• 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.

  PMID: 30839270 BACKGROUND

• 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.

  PMID: 28100160 BACKGROUND

• 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.

  PMID: 29164993 BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Maxime Gilliaux, PhD

  Hôpital La Musse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: July 1, 2021
• Study Start: August 21, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)