SpondyloarthritisTaiChiSpANCT04700150
Tai Chi in Spondyloarthritis
A study testing Tai Chi 2 month and Tai Chi 4 month in people with Spondyloarthritis, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spondyloarthritis
- What is being tested?
- Tai Chi 2 month and Tai Chi 4 month
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2019to 22 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Spondyloarthritis
- Being tested
- Tai Chi 2 month, Tai Chi 4 month
- Keywords
- SPONDYLOARTHITIS, TAI CHI CHUAN, PHYSICAL ACTIVITY
- Medical subject headings
- Spondylarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi 2 monthOther
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 monthOther
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.
| Study group | Role | What they receive |
|---|---|---|
| interventional group A | Experimental | 2 tai chi session per week during 4 month (M0 to M4) Receives: Other: Tai Chi 4 month |
| Control group B | Placebo comparator | 2 tai chi session per week during 2 month (M2 to M4) Receives: Other: Tai Chi 2 month |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global physical activity time per week, Global Physical Activity Questionnaire
measured by modified Global Physical Activity Questionnaire (GPAQ) .
Measured: Month 0
Change in global physical activity time per week, Global Physical Activity Questionnaire
measured by modified Global Physical Activity Questionnaire (GPAQ) .
Measured: 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.
Measured: 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.
Measured: Month 2
Secondary outcomes (10)
Change in Physical activity time of light intensity, moderate intensity, high intensity
measured by an accelerometer
Measured: Month 0
Change in Physical activity time of light intensity, moderate intensity, high intensity
measured by an accelerometer
Measured: Month 2
Change in Physical activity time of light intensity, moderate intensity, high intensity
measured by an accelerometer
Measured: Month 4
Change in Physical activity time of light intensity, moderate intensity, high intensity
measured by the modified Global Physical Activity Questionnaire
Measured: Month 0
Change in Physical activity time of light intensity, moderate intensity, high intensity
measured by the modified Global Physical Activity Questionnaire
Measured: Month 2
Change in Physical activity time of light intensity, moderate intensity, high intensity
measured by the modified Global Physical Activity Questionnaire
Measured: Month 4
Change in Sedentary time
measured by modified Global Physical Activity Questionnaire
Measured: Month 2
Change in Sedentary time
measured by modified Global Physical Activity Questionnaire
Measured: Month 4
Change in Sedentary time
measured by an accelerometer
Measured: Month 2
Change in Sedentary time
measured by an accelerometer
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start7 Jan 2019
- Primary completion22 Jul 2021
- Study completion22 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Soubrier, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700150
- Sponsor's protocol ID
- RBHP 2018 SOUBRIER
- Other IDs
- 2018-A01275-50
- Acronym
- TaiChiSpA
- Status last verified
- Aug 2026
- First submitted
- 6 Jan 2021
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fayet F, Fan A, Pereira B, Lambert C, Perron L, Rodere M, Duclos M, Soubrier M. Effects of face-to-face and remote Tai Chi in stable axial spondyloarthritis: a pilot randomised controlled trial. Rheumatol Int. 2025 Aug 1;45(8):178. doi: 10.1007/s00296-025-05912-5.
PubMed 40748484
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tai Chi Protocol on Global Physical Activity in Patients With Spondyloarthitis in Comparison With a Control Group
- ClinicalTrials.gov ID
- NCT04700150
- Acronym / sponsor ID
- TaiChiSpA / RBHP 2018 SOUBRIER
- Conditions
- Spondyloarthritis
- Keywords
- SPONDYLOARTHITIS, TAI CHI CHUAN, PHYSICAL ACTIVITY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 22 Jul 2021 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional group A | Experimental | Other: Tai Chi 4 month2 tai chi session per week during 4 month (M0 to M4) |
| Control group B | Placebo comparator | Other: Tai Chi 2 month2 tai chi session per week during 2 month (M2 to M4) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi 2 monthTai 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. | Other | Control group B |
| Tai Chi 4 monthTai 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. | Other | interventional group A |
Primary outcome
Change in global physical activity time per week, Global Physical Activity Questionnaire
Time frame: Month 0
measured by modified Global Physical Activity Questionnaire (GPAQ) .
Change in global physical activity time per week, Global Physical Activity Questionnaire
Time frame: Month 2
measured by modified Global Physical Activity Questionnaire (GPAQ) .
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.
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.
10 secondary outcomes
Change in Physical activity time of light intensity, moderate intensity, high intensity
Time frame: Month 0
Change in Physical activity time of light intensity, moderate intensity, high intensity
Time frame: Month 2
Change in Physical activity time of light intensity, moderate intensity, high intensity
Time frame: Month 4
Change in Physical activity time of light intensity, moderate intensity, high intensity
Time frame: Month 0
Change in Physical activity time of light intensity, moderate intensity, high intensity
Time frame: Month 2
Change in Physical activity time of light intensity, moderate intensity, high intensity
Time frame: Month 4
Change in Sedentary time
Time frame: Month 2
Change in Sedentary time
Time frame: Month 4
Change in Sedentary time
Time frame: Month 2
Change in Sedentary time
Time frame: Month 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Results publication: PubMed 40748484Fayet F, Fan A, Pereira B, Lambert C, Perron L, Rodere M, Duclos M, Soubrier M. Effects of face-to-face and remote Tai Chi in stable axial spondyloarthritis: a pilot randomised controlled trial. Rheumatol Int. 2025 Aug 1;45(8):178. doi: 10.1007/s00296-025-05912-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Soubrier principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi 2 month and Tai Chi 4 month in people with Spondyloarthritis, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global physical activity time per week, Global Physical Activity Questionnaire (time frame: Month 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04700150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.