Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2019-01-31
2020-06-30
Brief Summary
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Detailed Description
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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 Month 0). They will participate in sessions in a deferred manner due to two per week for each group:
* Interventional "A" group: 32 sessions (on average 2/week) performed from Month 0 to Month 4 in 15 patients.
* Control "B" group: 16 sessions (on average 2/week) performed from Month 2 to Month 4 in 15 patients.
Patients of "B" group will be not performing sessions with "A" group patients. Sessions lasting about 45 minutes will be proposed from Monday to Friday in a room planned from this activity within the CHU. Exercises will be adapted and personalized according to each one. Evaluations will be carried out for group 1 (interventional) before the first session of tai chi at Month 0, before the session at Month 2 and at the end of the protocol at Month 4. The same evaluations will be carried out for group B (control) at Month 0, before first session of tai chi at Month 2 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 4 months after randomization. Fitness assessment and tai chi sessions will be conducted by APA student. Clinical examination of patient, installation and removal of cardio frequency meter will be performed by nurse. Data entry will be done by Clinical Research Associate of the Rheumatology Department. Statistical analysis will be carried out by biostatistician affiliated to the study.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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interventional group A
2 tai chi session per week during 4 month (M0 to M4)
Tai chi chuan
Tai chi sessions will consist of repetition of simple and basic movements focusing mainly on breating, relaxation and body diagram. This Chinese martial art also includes coordination exercises of body parts (legs, arms, pelvis and spine), looseness and limbering up of joints and muscles.
Control group B
2 tai chi session per week during 2 month (M2 to M4)
Tai chi chuan
Tai chi sessions will consist of repetition of simple and basic movements focusing mainly on breating, relaxation and body diagram. This Chinese martial art also includes coordination exercises of body parts (legs, arms, pelvis and spine), looseness and limbering up of joints and muscles.
Interventions
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Tai chi chuan
Tai chi sessions will consist of repetition of simple and basic movements focusing mainly on breating, relaxation and body diagram. This Chinese martial art also includes coordination exercises of body parts (legs, arms, pelvis and spine), looseness and limbering up of joints and muscles.
Eligibility Criteria
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Inclusion Criteria
* Patient able to walk without help
* Patient able to complete a questionnaire
* Patient giving informed consent.
* Patient covered by social security
Exclusion Criteria
* Patient who has previously contribute to a tai chi program.
* Patient with an absolute contraindication to physical activity.
* Protected populations: pregnant women, breastfeeding women, tutorship, trusteeship, deprived of liberty, safeguard of justice.
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Martin SOUBRIER, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Ekelund U, Steene-Johannessen J, Brown WJ, Fagerland MW, Owen N, Powell KE, Bauman A, Lee IM; Lancet Physical Activity Series 2 Executive Committe; Lancet Sedentary Behaviour Working Group. Does physical activity attenuate, or even eliminate, the detrimental association of sitting time with mortality? A harmonised meta-analysis of data from more than 1 million men and women. Lancet. 2016 Sep 24;388(10051):1302-10. doi: 10.1016/S0140-6736(16)30370-1. Epub 2016 Jul 28.
Gossec L, Paternotte S, Aanerud GJ, Balanescu A, Boumpas DT, Carmona L, de Wit M, Dijkmans BA, Dougados M, Englbrecht M, Gogus F, Heiberg T, Hernandez C, Kirwan JR, Mola EM, Cerinic MM, Otsa K, Schett G, Scholte-Voshaar M, Sokka T, von Krause G, Wells GA, Kvien TK. Finalisation and validation of the rheumatoid arthritis impact of disease score, a patient-derived composite measure of impact of rheumatoid arthritis: a EULAR initiative. Ann Rheum Dis. 2011 Jun;70(6):935-42. doi: 10.1136/ard.2010.142901.
Guidoux R, Duclos M, Fleury G, Lacomme P, Lamaudiere N, Manenq PH, Paris L, Ren L, Rousset S. A smartphone-driven methodology for estimating physical activities and energy expenditure in free living conditions. J Biomed Inform. 2014 Dec;52:271-8. doi: 10.1016/j.jbi.2014.07.009. Epub 2014 Jul 15.
Guidoux R, Duclos M, Fleury G, Lacomme P, Lamaudiere N, Saboul D, Ren L, Rousset S. The eMouveRecherche application competes with research devices to evaluate energy expenditure, physical activity and still time in free-living conditions. J Biomed Inform. 2017 May;69:128-134. doi: 10.1016/j.jbi.2017.04.005. Epub 2017 Apr 9.
Jones SD, Porter J, Garrett SL, Kennedy LG, Whitelock H, Calin A. A new scoring system for the Bath Ankylosing Spondylitis Metrology Index (BASMI). J Rheumatol. 1995 Aug;22(8):1609. No abstract available.
Uhlig T. Tai Chi and yoga as complementary therapies in rheumatologic conditions. Best Pract Res Clin Rheumatol. 2012 Jun;26(3):387-98. doi: 10.1016/j.berh.2012.05.006.
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.
Waite-Jones JM, Hale CA, Lee HY. Psychosocial effects of Tai Chi exercise on people with rheumatoid arthritis. J Clin Nurs. 2013 Nov;22(21-22):3053-61. doi: 10.1111/jocn.12327. Epub 2013 Sep 13.
Wang C. Role of Tai Chi in the treatment of rheumatologic diseases. Curr Rheumatol Rep. 2012 Dec;14(6):598-603. doi: 10.1007/s11926-012-0294-y.
Wang C. Tai Chi improves pain and functional status in adults with rheumatoid arthritis: results of a pilot single-blinded randomized controlled trial. Med Sport Sci. 2008;52:218-229. doi: 10.1159/000134302.
Other Identifiers
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2017-A03294-49
Identifier Type: OTHER
Identifier Source: secondary_id
CHU-400
Identifier Type: -
Identifier Source: org_study_id
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