NCT03840785

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2020

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

January 28, 2019

Last Update Submit

March 4, 2021

Conditions

Rheumatoid Arthritis (RA)Spondyloarthritis (SA)

Keywords

Chronic inflammatory arthritisargentine tangophysical activity

Outcome Measures

Primary Outcomes (1)

  • 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.

    between month 0 and month3

Secondary Outcomes (5)

  • Change in total physical activity time

    at 3 months and 6 months

  • Physical activity time of light intensity

    at 3 months and 6 months

  • Physical activity time of moderate intensit

    at 3 months and 6 months

  • Physical activity time of high intensity

    at 3 months and 6 months

  • Sedentary time by the modified GPAQ questionnaire (Global Physical Activity)Questionnaire)

    at 3 months and 6 months

Study Arms (2)

interventional group A

EXPERIMENTAL

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

Other: Argentine tango

Control group B

PLACEBO COMPARATOR

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

Other: Argentine tango

Interventions

Argentine tangoOTHER

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

Control group Binterventional 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 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (10)

  • 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.

    PMID: 25599350BACKGROUND

  • 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.

    PMID: 19026141BACKGROUND

  • 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.

    PMID: 28967710BACKGROUND

  • 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.

    PMID: 28087505BACKGROUND

  • 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.

    PMID: 29407043BACKGROUND

  • 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.

    PMID: 26219268BACKGROUND

  • 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.

    PMID: 25370164BACKGROUND

  • 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.

    PMID: 29043493BACKGROUND

  • 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.

    PMID: 26542475BACKGROUND

  • 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.

    PMID: 25492375BACKGROUND

MeSH Terms

Conditions

Arthritis, RheumatoidSpondylarthritisMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylitisSpinal DiseasesBone DiseasesBehavior

Study Officials

  • Martine DUCLOS

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
no masking
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

February 15, 2019

Study Start

January 8, 2019

Primary Completion

March 12, 2020

Study Completion

March 12, 2020

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations

FR(1)