Clinical trial NCT04700150: Tai Chi in Spondyloarthritis
Official title: Effect of Tai Chi Protocol on Global Physical Activity in Patients With Spondyloarthitis in Comparison With a Control Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spondyloarthritis
Keywords: SPONDYLOARTHITIS
TAI CHI CHUAN
PHYSICAL ACTIVITY
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 40
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: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in global physical activity time per week, Global Physical Activity Questionnaire
timeFrame: Month 0
measure: Change in global physical activity time per week, Global Physical Activity Questionnaire
timeFrame: Month 2
measure: Change in global physical activity time per week, measured by an accelerometer
timeFrame: Month 0
measure: Change in global physical activity time per week, measured by an accelerometer
timeFrame: Month 2
Secondary outcomes:
measure: Change in Physical activity time of light intensity, moderate intensity, high intensity
timeFrame: Month 0
measure: Change in Physical activity time of light intensity, moderate intensity, high intensity
timeFrame: Month 2
measure: Change in Physical activity time of light intensity, moderate intensity, high intensity
timeFrame: Month 4
measure: Change in Physical activity time of light intensity, moderate intensity, high intensity
timeFrame: Month 0
measure: Change in Physical activity time of light intensity, moderate intensity, high intensity
timeFrame: Month 2
measure: Change in Physical activity time of light intensity, moderate intensity, high intensity
timeFrame: Month 4
measure: Change in Sedentary time
timeFrame: Month 2
measure: Change in Sedentary time
timeFrame: Month 4
measure: Change in Sedentary time
timeFrame: Month 2
measure: Change in Sedentary time
timeFrame: Month 4
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Martin Soubrier
role: PRINCIPAL_INVESTIGATOR
References: