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Completed

NCT Number: NCT04700150

Tai Chi in Spondyloarthritis

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tai Chi 2 month

Other

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

Other

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.

Primary outcomes

  1. Change in global physical activity time per week, Global Physical Activity Questionnaire

    Time frame: Month 0

    measured by modified Global Physical Activity Questionnaire (GPAQ) .

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

    Time frame: Month 2

    measured by modified Global Physical Activity Questionnaire (GPAQ) .

  3. Change in global physical activity time per week, measured by an accelerometer

    Time frame: 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

    Time frame: Month 2

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

Secondary outcomes

  1. Change in Physical activity time of light intensity, moderate intensity, high intensity

    Time frame: Month 0

    measured by an accelerometer

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

    Time frame: Month 2

    measured by an accelerometer

  3. Change in Physical activity time of light intensity, moderate intensity, high intensity

    Time frame: Month 4

    measured by an accelerometer

  4. Change in Physical activity time of light intensity, moderate intensity, high intensity

    Time frame: Month 0

    measured by the modified Global Physical Activity Questionnaire

  5. Change in Physical activity time of light intensity, moderate intensity, high intensity

    Time frame: Month 2

    measured by the modified Global Physical Activity Questionnaire

  6. Change in Physical activity time of light intensity, moderate intensity, high intensity

    Time frame: Month 4

    measured by the modified Global Physical Activity Questionnaire

  7. Change in Sedentary time

    Time frame: Month 2

    measured by modified Global Physical Activity Questionnaire

  8. Change in Sedentary time

    Time frame: Month 4

    measured by modified Global Physical Activity Questionnaire

  9. Change in Sedentary time

    Time frame: Month 2

    measured by an accelerometer

  10. Change in Sedentary time

    Time frame: Month 4

    measured by an accelerometer

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: TaiChiSpA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 7, 2021
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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