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Inflammatory Arthritis and Tango (IATANGO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03840785
Recruitment Status : Completed
First Posted : February 15, 2019
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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Brief Summary:
The hypothesis is that pleasure brought by argentine tango practice would increase total physical activity of patients with chronic inflammatory arthritis.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis (RA) Spondyloarthritis (SA) Other: Argentine tango Not Applicable

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: 48 sessions (on average 2/week) performed from M0 to M6 in 30 patients.
  • Control "B" group: 24 sessions (on average 2/week) performed from M3 to M6 in 30 patients.

Patients of "B" group will be not performing sessions with "A" group patients. Sessions lasting about 60 minutes will be proposed from Monday to Friday in a room planned from this activity within the CHU. They will be adapted and personalized according to each one. Evaluations will be carried out for group 1 (interventional) before the first session of tango at M0, before the session at M3 and at the end of the protocol at M6. The same evaluations will be carried out for group B (control) at M0, before first session of tango at M3 and at the end of the protocol.

Assessment of pain and stress will be done before and after each session. Final assessment will be done at 6 months after randomization. Fitness assessment and tango sessions will be conducted by an argentine tango teacher

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Masking Description: no masking
Primary Purpose: Treatment
Official Title: Effect of Argentine Tango Protocol on Total Physical Activity in Patients With Chronic Inflammatory Arthritis
Actual Study Start Date : January 8, 2019
Actual Primary Completion Date : March 12, 2020
Actual Study Completion Date : March 12, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: interventional group A
2 tango session per week during 6 month (M0 to M6)
 Other: Argentine tango

Argentine tango sessions will consist of:

  • Body perception and body control: sitting, standing then moving around four axes : space, time, energy, gravity.
  • Awareness of oneself, of other and music: listening, communication, touch, empathy, kinesthesia, letting go, feeling
Placebo Comparator: Control group B
2 tango session per week during 3 month (M3 to M6)
 Other: Argentine tango

Argentine tango sessions will consist of:

  • Body perception and body control: sitting, standing then moving around four axes : space, time, energy, gravity.
  • Awareness of oneself, of other and music: listening, communication, touch, empathy, kinesthesia, letting go, feeling


Outcome Measures
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Primary Outcome Measures :
  1. Change in total physical activity time [ Time Frame: between month 0 and month3 ]
    Total physical activity measured by Modified Global Physical Activity Questionnaire (GPAQ) between M0 and M3. Modified Global Physical Activity Questionnaire (GPAQ) questionnaire provides information on the time spent on different activities: work activity, utilitarian travel, hobbies and home-based activities. A specific energy expenditure is associated with each physical activity, which makes it possible to estimate the overall energy expenditure of the patients. It also provides information on sedentary time.


Secondary Outcome Measures :
  1. Change in total physical activity time [ Time Frame: at 3 months and 6 months ]
    Recording of total physical activity over a week by an accelerometer worn at the waist

  2. Physical activity time of light intensity [ Time Frame: at 3 months and 6 months ]
    measured by an accelerometer and measured by the modified GPAQ questionnaire (Global Physical Activity Questionnaire).Global Physical Activity Questionnaire (GPAQ) provides information on the time spent on different activities: work activity, utilitarian travel, hobbies and home-based activities.

  3. Physical activity time of moderate intensit [ Time Frame: at 3 months and 6 months ]
    measured by an accelerometer and measured by the modified GPAQ questionnaire (Global Physical Activity Questionnaire). Global Physical Activity Questionnaire (GPAQ) provides information on the time spent on different activities: work activity, utilitarian travel, hobbies and home-based activities.

  4. Physical activity time of high intensity [ Time Frame: at 3 months and 6 months ]
    : measured by an accelerometer and measured by the modified GPAQ. Global Physical Activity Questionnaire (GPAQ) provides information on the time spent on different activities: work activity, utilitarian travel, hobbies and home-based activities. questionnaire (Global Physical Activity Questionnaire)

  5. Sedentary time by the modified GPAQ questionnaire (Global Physical Activity)Questionnaire) [ Time Frame: at 3 months and 6 months ]
    Recording sedentary time over a week by an accelerometer worn at the waist


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient age > 18 years old with RA (ACR/EULAR criteria) in remission (CDAI ≤2.8) or with low disease activity (CDAI ≤10), or with SA (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 practicing argentine tango.
  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03840785


Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Martine DUCLOS University Hospital, Clermont-Ferrand
More Information
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Publications:

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03840785    
Other Study ID Numbers: CHU-422
2018-A01563-52 ( Other Identifier: 2018-A01563-52 )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021

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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:
Chronic inflammatory arthritis
argentine tango
physical activity
Additional relevant MeSH terms:
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Arthritis
Spondylarthritis
Joint Diseases
Musculoskeletal Diseases
 Spondylitis
Spinal Diseases
Bone Diseases