Tai Chi in Spondyloarthritis

Spondyloarthritis Clinical Trial

— TaiChiSpA  

Official title:

Effect of Tai Chi Protocol on Global Physical Activity in Patients With Spondyloarthitis in Comparison With a Control Group

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04700150
• Other study ID #: RBHP 2018 SOUBRIER
• Secondary ID: 2018-A01275-50
• Status: Completed
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: July 22, 2021

Study information

• Verified date: June 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 22, 2021
• Est. primary completion date: July 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Spondylarthritis
• Spondyloarthritis

Intervention

Other:
• Tai Chi 2 month
Tai chi sessions will consist of repetition of simple and basic movements focusing mainly on breathing, 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.
• Tai Chi 4 month
Tai chi sessions will consist of repetition of simple and basic movements focusing mainly on breathing, 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.

Locations

Country	Name	City	State
France	Chu Clermont Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in global physical activity time per week, Global Physical Activity Questionnaire	measured by modified Global Physical Activity Questionnaire (GPAQ) .	Month 0
Primary	Change in global physical activity time per week, Global Physical Activity Questionnaire	measured by modified Global Physical Activity Questionnaire (GPAQ) .	Month 2
Primary	Change in global physical activity time per week, measured by an accelerometer	measured by an accelerometer between M0 and M2 expressed in MET.min/week.	Month 0
Primary	Change in global physical activity time per week, measured by an accelerometer	measured by an accelerometer between M0 and M2 expressed in MET.min/week.	Month 2
Secondary	Change in Physical activity time of light intensity, moderate intensity, high intensity	measured by an accelerometer	Month 0
Secondary	Change in Physical activity time of light intensity, moderate intensity, high intensity	measured by an accelerometer	Month 2
Secondary	Change in Physical activity time of light intensity, moderate intensity, high intensity	measured by an accelerometer	Month 4
Secondary	Change in Physical activity time of light intensity, moderate intensity, high intensity	measured by the modified Global Physical Activity Questionnaire	Month 0
Secondary	Change in Physical activity time of light intensity, moderate intensity, high intensity	measured by the modified Global Physical Activity Questionnaire	Month 2
Secondary	Change in Physical activity time of light intensity, moderate intensity, high intensity	measured by the modified Global Physical Activity Questionnaire	Month 4
Secondary	Change in Sedentary time	measured by modified Global Physical Activity Questionnaire	Month 2
Secondary	Change in Sedentary time	measured by modified Global Physical Activity Questionnaire	Month 4
Secondary	Change in Sedentary time	measured by an accelerometer	Month 2
Secondary	Change in Sedentary time	measured by an accelerometer	Month 4