NCT03678363

Tai Chi in Rheumatoid Arthritis (TaiChiRA)

Effect of Tai Chi Protocol on Total Physical Activity in Patients With Rheumatoid Arthritis, in Comparison With a Control Group Without Tai Chi.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
OTHER	Tai chi chuan	Tai chi sessions will consist of repetition of simple and basic movements focusing mainly on breating, 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.

Timeline

• Start date: 2019-01-31
• Primary completion: 2020-01-31
• Completion: 2020-06-30
• First posted: 2018-09-19
• Last updated: 2019-01-30

Locations

1 site across 1 country: France