<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03840785</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-422</org_study_id>
    <secondary_id>2018-A01563-52</secondary_id>
    <nct_id>NCT03840785</nct_id>
  </id_info>
  <brief_title>Inflammatory Arthritis and Tango</brief_title>
  <acronym>IATANGO</acronym>
  <official_title>Effect of Argentine Tango Protocol on Total Physical Activity in Patients With Chronic Inflammatory Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The hypothesis is that pleasure brought by argentine tango practice would increase total&#xD;
      physical activity of patients with chronic inflammatory arthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Selection and inclusion of patients will be done by principal investigator of Rheumatology&#xD;
      Department. After verification of inclusion and non-inclusion criteria by principal&#xD;
      investigator and signature of consent, patients will be randomized by 1: 1 randomization&#xD;
      (centralized randomization by statistician into 2 groups at M0). They will participate in&#xD;
      sessions in a deferred manner due to two per week for each group:&#xD;
&#xD;
        -  Interventional &quot;A&quot; group: 48 sessions (on average 2/week) performed from M0 to M6 in 30&#xD;
           patients.&#xD;
&#xD;
        -  Control &quot;B&quot; group: 24 sessions (on average 2/week) performed from M3 to M6 in 30&#xD;
           patients.&#xD;
&#xD;
      Patients of &quot;B&quot; group will be not performing sessions with &quot;A&quot; group patients. Sessions&#xD;
      lasting about 60 minutes will be proposed from Monday to Friday in a room planned from this&#xD;
      activity within the CHU. They will be adapted and personalized according to each one.&#xD;
      Evaluations will be carried out for group 1 (interventional) before the first session of&#xD;
      tango at M0, before the session at M3 and at the end of the protocol at M6. The same&#xD;
      evaluations will be carried out for group B (control) at M0, before first session of tango at&#xD;
      M3 and at the end of the protocol.&#xD;
&#xD;
      Assessment of pain and stress will be done before and after each session. Final assessment&#xD;
      will be done at 6 months after randomization. Fitness assessment and tango sessions will be&#xD;
      conducted by an argentine tango teacher&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Actual">March 12, 2020</completion_date>
  <primary_completion_date type="Actual">March 12, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>no masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in total physical activity time</measure>
    <time_frame>between month 0 and month3</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in total physical activity time</measure>
    <time_frame>at 3 months and 6 months</time_frame>
    <description>Recording of total physical activity over a week by an accelerometer worn at the waist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity time of light intensity</measure>
    <time_frame>at 3 months and 6 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity time of moderate intensit</measure>
    <time_frame>at 3 months and 6 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity time of high intensity</measure>
    <time_frame>at 3 months and 6 months</time_frame>
    <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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedentary time by the modified GPAQ questionnaire (Global Physical Activity)Questionnaire)</measure>
    <time_frame>at 3 months and 6 months</time_frame>
    <description>Recording sedentary time over a week by an accelerometer worn at the waist</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Rheumatoid Arthritis (RA)</condition>
  <condition>Spondyloarthritis (SA)</condition>
  <arm_group>
    <arm_group_label>interventional group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 tango session per week during 6 month (M0 to M6)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group B</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 tango session per week during 3 month (M3 to M6)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Argentine tango</intervention_name>
    <description>Argentine tango sessions will consist of:&#xD;
Body perception and body control: sitting, standing then moving around four axes : space, time, energy, gravity.&#xD;
Awareness of oneself, of other and music: listening, communication, touch, empathy, kinesthesia, letting go, feeling</description>
    <arm_group_label>Control group B</arm_group_label>
    <arm_group_label>interventional group A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient age &gt; 18 years old with RA (ACR/EULAR criteria) in remission (CDAI ≤2.8) or&#xD;
             with low disease activity (CDAI ≤10), or with SA (ASAS criteria) with activity deemed&#xD;
             stable by rheumatologist.&#xD;
&#xD;
          -  Patient able to walk without help&#xD;
&#xD;
          -  Patient able to complete a questionnaire&#xD;
&#xD;
          -  Patient giving informed consent.&#xD;
&#xD;
          -  Patient covered by social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with disorder of higher mental function or psychiatric disorders.&#xD;
&#xD;
          -  Patient practicing argentine tango.&#xD;
&#xD;
          -  Patient with an absolute contraindication to physical activity.&#xD;
&#xD;
          -  Protected populations: pregnant women, breastfeeding women, tutorship, trusteeship,&#xD;
             deprived of liberty, safeguard of justice.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martine DUCLOS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>25599350</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19026141</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28967710</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28087505</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>29407043</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26219268</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25370164</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>29043493</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26542475</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25492375</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>March 4, 2021</last_update_submitted>
  <last_update_submitted_qc>March 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic inflammatory arthritis</keyword>
  <keyword>argentine tango</keyword>
  <keyword>physical activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03840785
org study id: CHU-422
secondary id: 2018-A01563-52
nct id: NCT03840785
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The hypothesis is that pleasure brought by argentine tango practice would increase total
      physical activity of patients with chronic inflammatory arthritis.
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
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: no masking
measure: Change in total physical activity time
time frame: between month 0 and month3
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.
measure: Change in total physical activity time
time frame: at 3 months and 6 months
description: Recording of total physical activity over a week by an accelerometer worn at the waist
measure: Physical activity time of light intensity
time frame: at 3 months and 6 months
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.
measure: Physical activity time of moderate intensit
time frame: at 3 months and 6 months
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.
measure: Physical activity time of high intensity
time frame: at 3 months and 6 months
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)
measure: Sedentary time by the modified GPAQ questionnaire (Global Physical Activity)Questionnaire)
time frame: at 3 months and 6 months
description: Recording sedentary time over a week by an accelerometer worn at the waist
arm group label: interventional group A
arm group type: Experimental
description: 2 tango session per week during 6 month (M0 to M6)
arm group label: Control group B
arm group type: Placebo Comparator
description: 2 tango session per week during 3 month (M3 to M6)
intervention type: Other
intervention name: Argentine tango
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
arm group label: Control group B
arm group label: interventional group A
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Martine DUCLOS
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
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.
PMID: 25599350
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.
PMID: 19026141
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.
PMID: 28967710
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.
PMID: 28087505
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.
PMID: 29407043
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.
PMID: 26219268
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.
PMID: 25370164
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.
PMID: 29043493
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.
PMID: 26542475
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.
PMID: 25492375
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Arthritis
mesh term: Spondylarthritis