Tai Chi in Spondyloarthritis (TaiChiSpA)

University Hospital, Clermont-Ferrand

Status: Completed

Conditions: Spondyloarthritis

Treatments: Other: Tai Chi 2 month; Other: Tai Chi 4 month

Study type: Interventional

Funder types: Other

Identifiers

NCT04700150

2018-A01275-50 (Other Identifier)

RBHP 2018 SOUBRIER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

interventional group A

Experimental group

Description:

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

Treatment:

Other: Tai Chi 4 month

Control group B

Placebo Comparator group

Description:

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

Treatment:

Other: Tai Chi 2 month