Tai Chi in Spondyloarthritis

Not Applicable

Completed

• Conditions: Spondyloarthritis
• Interventions: Other: Tai Chi 4 month; Other: Tai Chi 2 month

• Registration Number: NCT04700150
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2019-01-07
• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-07
• Primary Completion: 2021-07-22
• Study Completion: 2021-07-22
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
interventional group A	Tai Chi 4 month	2 tai chi session per week during 4 month (M0 to M4)
Control group B	Tai Chi 2 month	2 tai chi session per week during 2 month (M2 to M4)

Primary Outcome Measures

Name	Time	Method
Change in global physical activity time per week, Global Physical Activity Questionnaire	Month 2	measured by modified Global Physical Activity Questionnaire (GPAQ) .
Change in global physical activity time per week, measured by an accelerometer	Month 2	measured by an accelerometer between M0 and M2 expressed in MET.min/week.

Secondary Outcome Measures

Name	Time	Method
Change in Physical activity time of light intensity, moderate intensity, high intensity	Month 4	measured by the modified Global Physical Activity Questionnaire
Change in Sedentary time	Month 4	measured by an accelerometer

Trial Locations

Locations (1)

Chu Clermont Ferrand; 🇫🇷 Clermont-Ferrand, France