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
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
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
NCT ID
NCT03840785
First Posted
January 28, 2019
Last Updated
March 4, 2021
Sponsor
University Hospital, Clermont-Ferrand
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:
PubMed Identifier
25599350
Citation
Biswas A, Oh PI, Faulkner GE, Bajaj RR, Silver MA, Mitchell MS, Alter DA. Sedentary time and its association with risk for disease incidence, mortality, and hospitalization in adults: a systematic review and meta-analysis. Ann Intern Med. 2015 Jan 20;162(2):123-32. doi: 10.7326/M14-1651. Erratum In: Ann Intern Med. 2015 Sep 1;163(5):400.
Results Reference
background
PubMed Identifier
19026141
Citation
Sokka T, Hakkinen A. Poor physical fitness and performance as predictors of mortality in normal populations and patients with rheumatic and other diseases. Clin Exp Rheumatol. 2008 Sep-Oct;26(5 Suppl 51):S14-20.
Results Reference
background
PubMed Identifier
28967710
Citation
Garner S, Fenton T, Martin L, Creaser C, Johns C, Barnabe C. Personalized diet and exercise recommendations in early rheumatoid arthritis: A feasibility trial. Musculoskeletal Care. 2018 Mar;16(1):167-172. doi: 10.1002/msc.1214. Epub 2017 Oct 2.
Results Reference
background
PubMed Identifier
28087505
Citation
van der Heijde D, Ramiro S, Landewe R, Baraliakos X, Van den Bosch F, Sepriano A, Regel A, Ciurea A, Dagfinrud H, Dougados M, van Gaalen F, Geher P, van der Horst-Bruinsma I, Inman RD, Jongkees M, Kiltz U, Kvien TK, Machado PM, Marzo-Ortega H, Molto A, Navarro-Compan V, Ozgocmen S, Pimentel-Santos FM, Reveille J, Rudwaleit M, Sieper J, Sampaio-Barros P, Wiek D, Braun J. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017 Jun;76(6):978-991. doi: 10.1136/annrheumdis-2016-210770. Epub 2017 Jan 13.
Results Reference
background
PubMed Identifier
29407043
Citation
Wendling D, Lukas C, Prati C, Claudepierre P, Gossec L, Goupille P, Hudry C, Miceli-Richard C, Molto A, Pham T, Saraux A, Dougados M. 2018 update of French Society for Rheumatology (SFR) recommendations about the everyday management of patients with spondyloarthritis. Joint Bone Spine. 2018 May;85(3):275-284. doi: 10.1016/j.jbspin.2018.01.006. Epub 2018 Mar 8.
Results Reference
background
PubMed Identifier
26219268
Citation
Veldhuijzen van Zanten JJ, Rouse PC, Hale ED, Ntoumanis N, Metsios GS, Duda JL, Kitas GD. Perceived Barriers, Facilitators and Benefits for Regular Physical Activity and Exercise in Patients with Rheumatoid Arthritis: A Review of the Literature. Sports Med. 2015 Oct;45(10):1401-12. doi: 10.1007/s40279-015-0363-2.
Results Reference
background
PubMed Identifier
25370164
Citation
Fongen C, Sveaas SH, Dagfinrud H. Barriers and Facilitators for Being Physically Active in Patients with Ankylosing Spondylitis: A Cross-sectional Comparative Study. Musculoskeletal Care. 2015 Jun;13(2):76-83. doi: 10.1002/msc.1088. Epub 2014 Nov 5.
Results Reference
background
PubMed Identifier
29043493
Citation
Larkin L, Gallagher S, Fraser A, Kennedy N. Community-based intervention to promote physical activity in rheumatoid arthritis (CIPPA-RA): a study protocol for a pilot randomised control trial. Rheumatol Int. 2017 Dec;37(12):2095-2103. doi: 10.1007/s00296-017-3850-y. Epub 2017 Oct 17.
Results Reference
background
PubMed Identifier
26542475
Citation
Lotzke D, Ostermann T, Bussing A. Argentine tango in Parkinson disease--a systematic review and meta-analysis. BMC Neurol. 2015 Nov 5;15:226. doi: 10.1186/s12883-015-0484-0.
Results Reference
background
PubMed Identifier
25492375
Citation
Cleland CL, Hunter RF, Kee F, Cupples ME, Sallis JF, Tully MA. Validity of the global physical activity questionnaire (GPAQ) in assessing levels and change in moderate-vigorous physical activity and sedentary behaviour. BMC Public Health. 2014 Dec 10;14:1255. doi: 10.1186/1471-2458-14-1255.
Results Reference
background
Learn more about this trial
Inflammatory Arthritis and Tango
We'll reach out to this number within 24 hrs