Tai Chi in Rheumatoid Arthritis (TaiChiRA)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: Tai chi chuan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional group A<br>2 tai chi session per week during 4 month (M0 to M4) | Other: Tai chi chuan<br>* 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.<br>|
| Placebo Comparator: Control group B<br>2 tai chi session per week during 2 month (M2 to M4) | Other: Tai chi chuan<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total physical activity time expressed in min/ day between M0 and M2 measured by eMouve smartphone application | Android application allows to estimate in usual conditions of life the energy expenditure and time spent in three intensities of physical activities: light, moderate and vigorous, as well as the time spent in sedentary behaviors. Android smartphone with application eMouve will be entrusted to patients to collect information from their physical activity (PA) for 4 days (2 days of the week and 2 days of weekend). | 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). | 
| 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) | Modified Global Physical Activity Questionnaire provides a longitudinal assessment of a typical week for physical activity and sedentary behaviors. It covers three areas of activities: work activity, utilitarian travel, leisure activities and home-based activities. This questionnaire provides information on time spent on different activities in each of three areas mentioned above. A specific energy expenditure is associated with each PA, which makes it possible to estimate the overall energy expenditure of the patients. It also provides information on sedentary time. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | CDAI score (Clinical Disease Activity Index) corresponds to the algebraic sum of the number of painful (N=28) and swollen (N=28) joints, of disease activity judged by patient on analogical visual scale (AVS) from 0 to 10 cm and disease activity on AVS from 0 to 10cm evaluated by the physician. Remission is defined by a score ≤ 2.8 and low activity by a score ≤ 10. | at M0, M2 and M4 after 16 sessions | 
| Sedentary time expressed in ME.min/week measured by modified Global Physical Activity Questionnaire. | Modified Global Physical Activity Questionnaire provides a longitudinal assessment of a typical week for physical activity and sedentary behaviors. It covers three areas of activities: work activity, utilitarian travel, leisure activities and home-based activities. This questionnaire provides information on time spent on different activities in each of three areas mentioned above. A specific energy expenditure is associated with each PA, which makes it possible to estimate the overall energy expenditure of the patients. It also provides information on sedentary time. | 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). | 
| Physical activity time of light intensity, moderate intensity, high intensity measured by the modified GPAQ expressed in ME.minute/week | Modified Global Physical Activity Questionnaire provides a longitudinal assessment of a typical physical activity and sedentary behaviors. It covers three areas of activity: work activity, utilitarian travel, leisure activities and home-based activities. This questionnaire provides information on time spent on different activities in each of three areas mentioned above. A specific energy expenditure is associated with each PA which allows to estimate the overall energy expenditure of the patients. It also provides information on sedentary time. | 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). | 
| Schober test | Schober test consists of evaluating flexion amplitude of lumbar spine: two marks are made at L5 vertebra and 10cm above this lumbar vertebra, in a standing patient. Patient is then asked to lean forward and measure the increase in gap between two marks previously practiced. A gap of less than 3cm is considered pathological, the expected normal is +5cm. | 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). | 
| The single leg stance test | Subject must stand unassited on one leg and is timed in seconds from the time one foot is flexed off the floor to the time when it touches the ground or the standing leg or an arm leaves the hip. Goal is to maintain a balance as long as possible. Test is performed on each leg with eyes open and eyes closed. | 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). | 
| 6 minutes walk test | The 6 minutes walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. | 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). | 
| Handgrip strengh test | Muscular strength of both hands will be measured by dynamometry. Dynamometer electronics interpret voltage to display it as a unit of force. Best of three tries on each side is retained and scored (one value for each slide). | 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). | 
| Sit-to-stand test | Muscle strength of lower limbs will be measured by sit-to-stand test. Participant sits in middle of a chair, his back straight, his feet flat on the floor. Arms are crossed and hands resting on the chest. At the signal, participant gets up completely before sitting down in the initial position. He is invited to realize the maximum of lifts during 30 seconds. | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, Tai chi chuan, Physical Activity