NCT04700150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2021

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

2.5 years

First QC Date

January 6, 2021

Last Update Submit

June 3, 2022

Conditions

Spondyloarthritis

Keywords

SPONDYLOARTHITISTAI CHI CHUANPHYSICAL ACTIVITY

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (10)

  • Change in Physical activity time of light intensity, moderate intensity, high intensity

    Month 0

  • Change in Physical activity time of light intensity, moderate intensity, high intensity

    Month 2

  • Change in Physical activity time of light intensity, moderate intensity, high intensity

    Month 4

  • Change in Physical activity time of light intensity, moderate intensity, high intensity

    Month 0

  • Change in Physical activity time of light intensity, moderate intensity, high intensity

    Month 2

  • +5 more secondary outcomes

Study Arms (2)

interventional group A

EXPERIMENTAL

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

Other: Tai Chi 4 month

Control group B

PLACEBO COMPARATOR

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

Other: Tai Chi 2 month

Interventions

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.

Control group B
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.

interventional group A

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • 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.

    PMID: 40748484DERIVED

MeSH Terms

Conditions

SpondylarthritisMotor Activity

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Martin Soubrier

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 7, 2021

Study Start

January 7, 2019

Primary Completion

July 22, 2021

Study Completion

July 22, 2021

Last Updated

June 6, 2022

Record last verified: 2022-06

Locations

FR(1)