Tai Chi in Spondyloarthritis (TaiChiSpA)

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

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.

Study Overview

• Status: Completed
• Conditions: Spondyloarthritis
• Intervention / Treatment: Other: Tai Chi 4 month; Other: Tai Chi 2 month

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Chu Clermont Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: interventional group A; 2 tai chi session per week during 4 month (M0 to M4)	Other: 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.
Placebo Comparator: Control group B; 2 tai chi session per week during 2 month (M2 to M4)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in global physical activity time per week, Global Physical Activity Questionnaire	measured by modified Global Physical Activity Questionnaire (GPAQ) .	Month 0
Change in global physical activity time per week, Global Physical Activity Questionnaire	measured by modified Global Physical Activity Questionnaire (GPAQ) .	Month 2
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical activity time of light intensity, moderate intensity, high intensity	measured by an accelerometer	Month 0
Change in Physical activity time of light intensity, moderate intensity, high intensity	measured by an accelerometer	Month 2
Change in Physical activity time of light intensity, moderate intensity, high intensity	measured by an accelerometer	Month 4
Change in Physical activity time of light intensity, moderate intensity, high intensity	measured by the modified Global Physical Activity Questionnaire	Month 0
Change in Physical activity time of light intensity, moderate intensity, high intensity	measured by the modified Global Physical Activity Questionnaire	Month 2
Change in Physical activity time of light intensity, moderate intensity, high intensity	measured by the modified Global Physical Activity Questionnaire	Month 4
Change in Sedentary time	measured by modified Global Physical Activity Questionnaire	Month 2
Change in Sedentary time	measured by modified Global Physical Activity Questionnaire	Month 4
Change in Sedentary time	measured by an accelerometer	Month 2
Change in Sedentary time	measured by an accelerometer	Month 4

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Martin SOUBRIER, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): July 22, 2021
• Study Completion (Actual): July 22, 2021

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: SPONDYLOARTHITIS; TAI CHI CHUAN; PHYSICAL ACTIVITY
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis
• Other Study ID Numbers: RBHP 2018 SOUBRIER; 2018-A01275-50 (Other Identifier: 2018-A01275-50)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No