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Tai Chi in Spondyloarthritis (TaiChiSpA)

Primary Purpose

Spondyloarthritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tai Chi 2 month
Tai Chi 4 month
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondyloarthritis focused on measuring SPONDYLOARTHITIS, TAI CHI CHUAN, PHYSICAL ACTIVITY

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Clermont Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

interventional group A

Control group B

Arm Description

2 tai chi session per week during 4 month (M0 to M4)

2 tai chi session per week during 2 month (M2 to M4)

Outcomes

Primary Outcome Measures

Change in global physical activity time per week, Global Physical Activity Questionnaire
measured by modified Global Physical Activity Questionnaire (GPAQ) .
Change in global physical activity time per week, Global Physical Activity Questionnaire
measured by modified Global Physical Activity Questionnaire (GPAQ) .
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.
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.

Secondary Outcome Measures

Change in Physical activity time of light intensity, moderate intensity, high intensity
measured by an accelerometer
Change in Physical activity time of light intensity, moderate intensity, high intensity
measured by an accelerometer
Change in Physical activity time of light intensity, moderate intensity, high intensity
measured by an accelerometer
Change in Physical activity time of light intensity, moderate intensity, high intensity
measured by the modified Global Physical Activity Questionnaire
Change in Physical activity time of light intensity, moderate intensity, high intensity
measured by the modified Global Physical Activity Questionnaire
Change in Physical activity time of light intensity, moderate intensity, high intensity
measured by the modified Global Physical Activity Questionnaire
Change in Sedentary time
measured by modified Global Physical Activity Questionnaire
Change in Sedentary time
measured by modified Global Physical Activity Questionnaire
Change in Sedentary time
measured by an accelerometer
Change in Sedentary time
measured by an accelerometer

Full Information

First Posted
January 6, 2021
Last Updated
June 3, 2022
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT04700150
Brief Title
Tai Chi in Spondyloarthritis
Acronym
TaiChiSpA
Official Title
Effect of Tai Chi Protocol on Global Physical Activity in Patients With Spondyloarthitis in Comparison With a Control Group
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
July 22, 2021 (Actual)
Study Completion Date
July 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis
Keywords
SPONDYLOARTHITIS, TAI CHI CHUAN, PHYSICAL ACTIVITY

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
interventional group A
Arm Type
Experimental
Arm Description
2 tai chi session per week during 4 month (M0 to M4)
Arm Title
Control group B
Arm Type
Placebo Comparator
Arm Description
2 tai chi session per week during 2 month (M2 to M4)
Intervention Type
Other
Intervention Name(s)
Tai Chi 2 month
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tai Chi 4 month
Intervention Description
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 Outcome Measure Information:
Title
Change in global physical activity time per week, Global Physical Activity Questionnaire
Description
measured by modified Global Physical Activity Questionnaire (GPAQ) .
Time Frame
Month 0
Title
Change in global physical activity time per week, Global Physical Activity Questionnaire
Description
measured by modified Global Physical Activity Questionnaire (GPAQ) .
Time Frame
Month 2
Title
Change in global physical activity time per week, measured by an accelerometer
Description
measured by an accelerometer between M0 and M2 expressed in MET.min/week.
Time Frame
Month 0
Title
Change in global physical activity time per week, measured by an accelerometer
Description
measured by an accelerometer between M0 and M2 expressed in MET.min/week.
Time Frame
Month 2
Secondary Outcome Measure Information:
Title
Change in Physical activity time of light intensity, moderate intensity, high intensity
Description
measured by an accelerometer
Time Frame
Month 0
Title
Change in Physical activity time of light intensity, moderate intensity, high intensity
Description
measured by an accelerometer
Time Frame
Month 2
Title
Change in Physical activity time of light intensity, moderate intensity, high intensity
Description
measured by an accelerometer
Time Frame
Month 4
Title
Change in Physical activity time of light intensity, moderate intensity, high intensity
Description
measured by the modified Global Physical Activity Questionnaire
Time Frame
Month 0
Title
Change in Physical activity time of light intensity, moderate intensity, high intensity
Description
measured by the modified Global Physical Activity Questionnaire
Time Frame
Month 2
Title
Change in Physical activity time of light intensity, moderate intensity, high intensity
Description
measured by the modified Global Physical Activity Questionnaire
Time Frame
Month 4
Title
Change in Sedentary time
Description
measured by modified Global Physical Activity Questionnaire
Time Frame
Month 2
Title
Change in Sedentary time
Description
measured by modified Global Physical Activity Questionnaire
Time Frame
Month 4
Title
Change in Sedentary time
Description
measured by an accelerometer
Time Frame
Month 2
Title
Change in Sedentary time
Description
measured by an accelerometer
Time Frame
Month 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Soubrier
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

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Tai Chi in Spondyloarthritis

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