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Inflammatory Arthritis and Tango (IATANGO)

Primary Purpose

Rheumatoid Arthritis (RA), Spondyloarthritis (SA)

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Argentine tango
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis (RA) focused on measuring Chronic inflammatory arthritis, argentine tango, 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 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.

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 tango session per week during 6 month (M0 to M6)

2 tango session per week during 3 month (M3 to M6)

Outcomes

Primary Outcome Measures

Change in total physical activity time
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

Change in total physical activity time
Recording of total physical activity over a week by an accelerometer worn at the waist
Physical activity time of light intensity
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.
Physical activity time of moderate intensit
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.
Physical activity time of high intensity
: 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)
Sedentary time by the modified GPAQ questionnaire (Global Physical Activity)Questionnaire)
Recording sedentary time over a week by an accelerometer worn at the waist

Full Information

First Posted
January 28, 2019
Last Updated
March 4, 2021
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03840785
Brief Title
Inflammatory Arthritis and Tango
Acronym
IATANGO
Official Title
Effect of Argentine Tango Protocol on Total Physical Activity in Patients With Chronic Inflammatory Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 8, 2019 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis (RA), Spondyloarthritis (SA)
Keywords
Chronic inflammatory arthritis, argentine tango, physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Masking Description
no masking
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
interventional group A
Arm Type
Experimental
Arm Description
2 tango session per week during 6 month (M0 to M6)
Arm Title
Control group B
Arm Type
Placebo Comparator
Arm Description
2 tango session per week during 3 month (M3 to M6)
Intervention Type
Other
Intervention Name(s)
Argentine tango
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in total physical activity time
Description
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.
Time Frame
between month 0 and month3
Secondary Outcome Measure Information:
Title
Change in total physical activity time
Description
Recording of total physical activity over a week by an accelerometer worn at the waist
Time Frame
at 3 months and 6 months
Title
Physical activity time of light intensity
Description
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.
Time Frame
at 3 months and 6 months
Title
Physical activity time of moderate intensit
Description
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.
Time Frame
at 3 months and 6 months
Title
Physical activity time of high intensity
Description
: 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)
Time Frame
at 3 months and 6 months
Title
Sedentary time by the modified GPAQ questionnaire (Global Physical Activity)Questionnaire)
Description
Recording sedentary time over a week by an accelerometer worn at the waist
Time Frame
at 3 months and 6 months

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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine DUCLOS
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

Citations:
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25599350
Citation
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Inflammatory Arthritis and Tango

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