Clinical trial NCT03678363: Tai Chi in Rheumatoid Arthritis (TaiChiRA)
Official title: Effect of Tai Chi Protocol on Total Physical Activity in Patients With Rheumatoid Arthritis, in Comparison With a Control Group Without Tai Chi.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Tai chi chuan
Physical Activity
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in total physical activity time expressed in min/ day between M0 and M2 measured by eMouve smartphone application
timeFrame: At Month 0 before the first session of tai chi and Month 2 after 16 sessions of tai chi (intervention group), measured at Month 0 and Month 2 (control group without tai chi).
measure: Change in total physical activity time expressed in MET.min/week between M0 and M2 measured by Global physical activity questionnaire (GPAQ Questionnaire (Global Physical Activity Questionnaire)
timeFrame: At Month 0 before the first session of tai chi and Month 2 after 16 sessions of tai chi (intervention group), measured at Month 0 and Month 2 (control group without tai chi).
Secondary outcomes:
measure: Disease activity, evaluated by CDAI score (Clinical Disease Activity Index) at M0, at M2 after 16 sessions and at M4 after 32 sessions (interventional group) and evaluated at M0, M2 and M4 after 16 sessions (control group).
timeFrame: at M0, M2 and M4 after 16 sessions
measure: Sedentary time expressed in ME.min/week measured by modified Global Physical Activity Questionnaire.
timeFrame: At Month 0, Month 2 after 16 sessions and at Month 4 after 32 sessions (interventional group) and measured at Month 0, Month 2 and Month 4 after 16 sessions (control group).
measure: Physical activity time of light intensity, moderate intensity, high intensity measured by the modified GPAQ expressed in ME.minute/week
timeFrame: At Month 0, at Month 2 after 16 sessions and at Month 4 after 32 sessions (interventional group) and measured at Month 0, Month 2 and Month 4 after sessions (control group).
measure: Schober test
timeFrame: At Month 0, at Month 2 after 16 sessions and at Month 4 after 32 sessions (group interventional) and measured at Month 0, Month 2 and Month 4 after 16 sessions (control group).
measure: The single leg stance test
timeFrame: At Month 0, at Month 2 after 16 sessions and at Month 4 after 32 sessions (group interventional) and measured at Month 0, Month 2 and Month 4 after 16 sessions (control group).
measure: 6 minutes walk test
timeFrame: At Month 0, at Month 2 after 16 sessions and at Month 4 after 32 sessions (group interventional) and measured at Month 0, Month 2 and Month 4 after 16 sessions (control group).
measure: Handgrip strengh test
timeFrame: At Month 0, at Month 2 after 16 sessions and at Month 4 after 32 sessions (group interventional) and measured at Month 0, Month 2 and Month 4 after 16 sessions (control group).
measure: Sit-to-stand test
timeFrame: At Month 0, at Month 2 after 16 sessions and at Month 4 after 32 sessions (group interventional) and measured at Month 0, Month 2 and Month 4 after 16 sessions (control group).
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
state: Auvergne
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Martin SOUBRIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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