Tai Chi in Rheumatoid Arthritis (TaiChiRA)

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Rheumatoid Arthritis

Treatments: Other: Tai chi chuan

Study type: Interventional

Funder types: Other

Identifiers

NCT03678363

2017-A03294-49 (Other Identifier)

CHU-400

Details and patient eligibility

About

The investigator's hypothesis is that tai chi sessions would increase physical activity of patients with Rheumatoid Arthritis. The main objective is to study the effect of tai chi sessions (16 vs.0) on total physical activity of Rheumatoid Arthritis patients, compared to a control group without tai chi.

Full description

Detail protocol:

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 Month 0). 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 Month 0 to Month 4 in 15 patients.
• Control "B" group: 16 sessions (on average 2/week) performed from Month 2 to Month 4 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 for group 1 (interventional) before the first session of tai chi at Month 0, before the session at Month 2 and at the end of the protocol at Month 4. The same evaluations will be carried out for group B (control) at Month 0, before first session of tai chi at Month 2 and at the end of the protocol.

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. Clinical examination of patient, installation and removal of cardio frequency meter will be performed by nurse. Data entry will be done by Clinical Research Associate of the Rheumatology Department. Statistical analysis will be carried out by biostatistician affiliated to the study.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient age > 18 years old with RA (ACR/EULAR criteria) in remission (CDAI ≤2.8) or with low disease activity (CDAI ≤10).
• 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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30 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 chuan

Control group B

Placebo Comparator group

Description:

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

Treatment:

Other: Tai chi chuan