TaiChiSpA: Tai Chi in Spondyloarthritis

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Completed
CT.gov ID
NCT04700150
Collaborator
(none)
40
1
2
30.5
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Tai Chi 2 month
  • Other: Tai Chi 4 month
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Tai Chi Protocol on Global Physical Activity in Patients With Spondyloarthitis in Comparison With a Control Group
Actual Study Start Date :
Jan 7, 2019
Actual Primary Completion Date :
Jul 22, 2021
Actual Study Completion Date :
Jul 22, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in global physical activity time per week, Global Physical Activity Questionnaire [Month 0]

    measured by modified Global Physical Activity Questionnaire (GPAQ) .

  2. Change in global physical activity time per week, Global Physical Activity Questionnaire [Month 2]

    measured by modified Global Physical Activity Questionnaire (GPAQ) .

  3. Change in global physical activity time per week, measured by an accelerometer [Month 0]

    measured by an accelerometer between M0 and M2 expressed in MET.min/week.

  4. Change in global physical activity time per week, measured by an accelerometer [Month 2]

    measured by an accelerometer between M0 and M2 expressed in MET.min/week.

Secondary Outcome Measures

  1. Change in Physical activity time of light intensity, moderate intensity, high intensity [Month 0]

    measured by an accelerometer

  2. Change in Physical activity time of light intensity, moderate intensity, high intensity [Month 2]

    measured by an accelerometer

  3. Change in Physical activity time of light intensity, moderate intensity, high intensity [Month 4]

    measured by an accelerometer

  4. Change in Physical activity time of light intensity, moderate intensity, high intensity [Month 0]

    measured by the modified Global Physical Activity Questionnaire

  5. Change in Physical activity time of light intensity, moderate intensity, high intensity [Month 2]

    measured by the modified Global Physical Activity Questionnaire

  6. Change in Physical activity time of light intensity, moderate intensity, high intensity [Month 4]

    measured by the modified Global Physical Activity Questionnaire

  7. Change in Sedentary time [Month 2]

    measured by modified Global Physical Activity Questionnaire

  8. Change in Sedentary time [Month 4]

    measured by modified Global Physical Activity Questionnaire

  9. Change in Sedentary time [Month 2]

    measured by an accelerometer

  10. Change in Sedentary time [Month 4]

    measured by an accelerometer

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Clermont Ferrand Clermont-Ferrand France 63003

Sponsors and Collaborators

  • University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Martin Soubrier, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT04700150
Other Study ID Numbers:
  • RBHP 2018 SOUBRIER
  • 2018-A01275-50
First Posted:
Jan 7, 2021
Last Update Posted:
Jun 6, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Clermont-Ferrand
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 6, 2022