Tai Chi in Spondyloarthritis

NCT ID: NCT04700150

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-07
• Study Completion Date: 2021-07-22

Brief Summary

Our hypothesis is that tai chi sessions would increase physical activity of patients with Spondyloarthitis. The main objective is to study the effect of tai chi sessions (16 vs.0) on global physical activity of Spondyloarthitis patients, compared to a control group without tai chi.

Detailed Description

Selection and inclusion of patients will be done by principal investigator of Rheumatology Department. After verification of inclusion and non-inclusion criteria by principal investigator and signature of consent, patients will be randomized by 1: 1 randomization (centralized randomization by statistician into 2 groups at M0). They will participate in sessions in a deferred manner due to two per week for each group:

• Interventional "A" group: 32 sessions (on average 2/week) performed from M0 to M4 in 15 patients.
• Control "B" group: 16 sessions (on average 2/week) performed from M2 to M4 in 15 patients.

Patients of "B" group will be not performing sessions with "A" group patients. Sessions lasting about 45 minutes will be proposed from Monday to Friday in a room planned from this activity within the CHU. Exercises will be adapted and personalized according to each one. Evaluations will be carried out at M0, M2 and at the end of the protocol at M4.

Assessment of pain and stress will be done before and after each session. Final assessment will be done at 4 months after randomization. Fitness assessment and tai chi sessions will be conducted by APA student.

Conditions

Spondyloarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

interventional group A

2 tai chi session per week during 4 month (M0 to M4)

Group Type: EXPERIMENTAL

Tai Chi 4 month

Intervention Type: OTHER

Tai chi sessions will consist of repetition of simple and basic movements focusing mainly on breathing, relaxation and body diagram. This Chinese martial art also includes coordination exercises of body parts (legs, arms, pelvis and spine), looseness and limbering up of joints and muscles.

Control group B

2 tai chi session per week during 2 month (M2 to M4)

Group Type: PLACEBO_COMPARATOR

Tai Chi 2 month

Intervention Type: OTHER

Tai chi sessions will consist of repetition of simple and basic movements focusing mainly on breathing, relaxation and body diagram. This Chinese martial art also includes coordination exercises of body parts (legs, arms, pelvis and spine), looseness and limbering up of joints and muscles.

Interventions

Tai Chi 2 month

Tai chi sessions will consist of repetition of simple and basic movements focusing mainly on breathing, relaxation and body diagram. This Chinese martial art also includes coordination exercises of body parts (legs, arms, pelvis and spine), looseness and limbering up of joints and muscles.

Intervention Type: OTHER

Tai Chi 4 month

Tai chi sessions will consist of repetition of simple and basic movements focusing mainly on breathing, relaxation and body diagram. This Chinese martial art also includes coordination exercises of body parts (legs, arms, pelvis and spine), looseness and limbering up of joints and muscles.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient age > 18 years old with Spondyloarthitis (ASAS criteria), with activity deemed stable by rheumatologist.
• Patient able to walk without help
• Patient able to complete a questionnaire
• Patient giving informed consent.
• Patient covered by social security

Exclusion Criteria

• Patient with disorder of higher mental function or psychiatric disorders.
• Patient who has previously contribute to a tai chi program.
• Patient with an absolute contraindication to physical activity.
• Protected populations: pregnant women, breastfeeding women, tutorship, trusteeship, deprived of liberty, safeguard of justice

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Soubrier

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

Chu Clermont Ferrand

Clermont-Ferrand, , France

Countries

France

References

Fayet F, Fan A, Pereira B, Lambert C, Perron L, Rodere M, Duclos M, Soubrier M. Effects of face-to-face and remote Tai Chi in stable axial spondyloarthritis: a pilot randomised controlled trial. Rheumatol Int. 2025 Aug 1;45(8):178. doi: 10.1007/s00296-025-05912-5.

Reference Type: DERIVED

PMID: 40748484 (View on PubMed)

Other Identifiers

2018-A01275-50

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2018 SOUBRIER

Identifier Type: -

Identifier Source: org_study_id