Rheumatoid ArthritisTaiChiRANCT03678363
Tai Chi in Rheumatoid Arthritis (TaiChiRA)
A study testing Tai chi chuan in people with Rheumatoid Arthritis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The investigator's hypothesis is that tai chi sessions would increase physical activity of patients with Rheumatoid Arthritis. The main objective is to study the effect of tai chi sessions (16 vs.0) on total physical activity of Rheumatoid Arthritis patients, compared to a control group without tai chi. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tai chi chuan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age > 18 years old with RA (ACR/EULAR criteria) in remission (CDAI ≤2.8) or with low disease activity (CDAI ≤10).
- Patient able to walk without help
- Patient able to complete a questionnaire
- Patient giving informed consent.
- Patient covered by social security
Who cannot join
- Patient with disorder of higher mental function or psychiatric disorders.
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
Lise LACLAUTRE, 04 73 75 49 63, drci@chu-clermontferrand.fr
Martin SOUBRIER, MD, PhD
About this study
Official title: Effect of Tai Chi Protocol on Total Physical Activity in Patients With Rheumatoid Arthritis, in Comparison With a Control Group Without Tai Chi.
The investigator's hypothesis is that tai chi sessions would increase physical activity of patients with Rheumatoid Arthritis. The main objective is to study the effect of tai chi sessions (16 vs.0) on total physical activity of Rheumatoid Arthritis patients, compared to a control group without tai chi.
Read the detailed description
Detail protocol:
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
- Rheumatoid Arthritis
- Being tested
- Tai chi chuan
- Keywords
- Rheumatoid Arthritis, Tai chi chuan, Physical Activity
- Medical subject headings
- Arthritis, Rheumatoid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai chi chuanOther
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.
| Study group | Role | What they receive |
|---|---|---|
| interventional group A | Experimental | 2 tai chi session per week during 4 month (M0 to M4) Receives: Other: Tai chi chuan |
| Control group B | Placebo comparator | 2 tai chi session per week during 2 month (M2 to M4) Receives: Other: Tai chi chuan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total physical activity time expressed in min/ day between M0 and M2 measured by eMouve smartphone application
Android application allows to estimate in usual conditions of life the energy expenditure and time spent in three intensities of physical activities: light, moderate and vigorous, as well as the time spent in sedentary behaviors. Android smartphone with application eMouve will be entrusted to patients to collect information from their physical activity (PA) for 4 days (2 days of the week and 2 days of weekend).
Measured: At Month 0 before the first session of tai chi and Month 2 after 16 sessions of tai chi (intervention group), measured at Month 0 and Month 2 (control group without tai chi).
Change in total physical activity time expressed in MET.min/week between M0 and M2 measured by Global physical activity questionnaire (GPAQ Questionnaire (Global Physical Activity Questionnaire)
Modified Global Physical Activity Questionnaire provides a longitudinal assessment of a typical week for physical activity and sedentary behaviors. It covers three areas of activities: work activity, utilitarian travel, leisure activities and home-based activities. This questionnaire provides information on time spent on different activities in each of three areas mentioned above. A specific energy expenditure is associated with each PA, which makes it possible to estimate the overall energy expenditure of the patients. It also provides information on sedentary time.
Measured: At Month 0 before the first session of tai chi and Month 2 after 16 sessions of tai chi (intervention group), measured at Month 0 and Month 2 (control group without tai chi).
Secondary outcomes (8)
Disease activity, evaluated by CDAI score (Clinical Disease Activity Index) at M0, at M2 after 16 sessions and at M4 after 32 sessions (interventional group) and evaluated at M0, M2 and M4 after 16 sessions (control group).
CDAI score (Clinical Disease Activity Index) corresponds to the algebraic sum of the number of painful (N=28) and swollen (N=28) joints, of disease activity judged by patient on analogical visual scale (AVS) from 0 to 10 cm and disease activity on AVS from 0 to 10cm evaluated by the physician. Remission is defined by a score ≤ 2.8 and low activity by a score ≤ 10.
Measured: at M0, M2 and M4 after 16 sessions
Sedentary time expressed in ME.min/week measured by modified Global Physical Activity Questionnaire.
Modified Global Physical Activity Questionnaire provides a longitudinal assessment of a typical week for physical activity and sedentary behaviors. It covers three areas of activities: work activity, utilitarian travel, leisure activities and home-based activities. This questionnaire provides information on time spent on different activities in each of three areas mentioned above. A specific energy expenditure is associated with each PA, which makes it possible to estimate the overall energy expenditure of the patients. It also provides information on sedentary time.
Measured: At Month 0, Month 2 after 16 sessions and at Month 4 after 32 sessions (interventional group) and measured at Month 0, Month 2 and Month 4 after 16 sessions (control group).
Physical activity time of light intensity, moderate intensity, high intensity measured by the modified GPAQ expressed in ME.minute/week
Modified Global Physical Activity Questionnaire provides a longitudinal assessment of a typical physical activity and sedentary behaviors. It covers three areas of activity: work activity, utilitarian travel, leisure activities and home-based activities. This questionnaire provides information on time spent on different activities in each of three areas mentioned above. A specific energy expenditure is associated with each PA which allows to estimate the overall energy expenditure of the patients. It also provides information on sedentary time.
Measured: At Month 0, at Month 2 after 16 sessions and at Month 4 after 32 sessions (interventional group) and measured at Month 0, Month 2 and Month 4 after sessions (control group).
Schober test
Schober test consists of evaluating flexion amplitude of lumbar spine: two marks are made at L5 vertebra and 10cm above this lumbar vertebra, in a standing patient. Patient is then asked to lean forward and measure the increase in gap between two marks previously practiced. A gap of less than 3cm is considered pathological, the expected normal is +5cm.
Measured: At Month 0, at Month 2 after 16 sessions and at Month 4 after 32 sessions (group interventional) and measured at Month 0, Month 2 and Month 4 after 16 sessions (control group).
The single leg stance test
Subject must stand unassited on one leg and is timed in seconds from the time one foot is flexed off the floor to the time when it touches the ground or the standing leg or an arm leaves the hip. Goal is to maintain a balance as long as possible. Test is performed on each leg with eyes open and eyes closed.
Measured: At Month 0, at Month 2 after 16 sessions and at Month 4 after 32 sessions (group interventional) and measured at Month 0, Month 2 and Month 4 after 16 sessions (control group).
6 minutes walk test
The 6 minutes walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Measured: At Month 0, at Month 2 after 16 sessions and at Month 4 after 32 sessions (group interventional) and measured at Month 0, Month 2 and Month 4 after 16 sessions (control group).
Handgrip strengh test
Muscular strength of both hands will be measured by dynamometry. Dynamometer electronics interpret voltage to display it as a unit of force. Best of three tries on each side is retained and scored (one value for each slide).
Measured: At Month 0, at Month 2 after 16 sessions and at Month 4 after 32 sessions (group interventional) and measured at Month 0, Month 2 and Month 4 after 16 sessions (control group).
Sit-to-stand test
Muscle strength of lower limbs will be measured by sit-to-stand test. Participant sits in middle of a chair, his back straight, his feet flat on the floor. Arms are crossed and hands resting on the chest. At the signal, participant gets up completely before sitting down in the initial position. He is invited to realize the maximum of lifts during 30 seconds.
Measured: At Month 0, at Month 2 after 16 sessions and at Month 4 after 32 sessions (group interventional) and measured at Month 0, Month 2 and Month 4 after 16 sessions (control group).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start31 Jan 2019 (estimated)
- Primary completion31 Jan 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin SOUBRIER, MD, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678363
- Sponsor's protocol ID
- CHU-400
- Other IDs
- 2017-A03294-49
- Acronym
- TaiChiRA
- Status last verified
- Jan 2019
- First submitted
- 12 Jul 2018
- Last updated
- 30 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25599350Cleland 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.
PubMed 25492375Ekelund 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.
PubMed 27475271Gossec 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.
PubMed 21540201Guidoux 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.
PubMed 25048352Guidoux 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.
PubMed 28400313Jones 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.
PubMed 7473496Uhlig 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.
PubMed 22867933Veldhuijzen 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.
PubMed 26219268Waite-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.
PubMed 24033836Wang 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.
PubMed 23055009Wang 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.
PubMed 18487901
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tai Chi Protocol on Total Physical Activity in Patients With Rheumatoid Arthritis, in Comparison With a Control Group Without Tai Chi.
- ClinicalTrials.gov ID
- NCT03678363
- Acronym / sponsor ID
- TaiChiRA / CHU-400
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Tai chi chuan, Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 31 Jan 2019 (estimated)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator's hypothesis is that tai chi sessions would increase physical activity of patients with Rheumatoid Arthritis. The main objective is to study the effect of tai chi sessions (16 vs.0) on total physical activity of Rheumatoid Arthritis patients, compared to a control group without tai chi.
Detailed description
Detail protocol:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional group A | Experimental | Other: Tai chi chuan2 tai chi session per week during 4 month (M0 to M4) |
| Control group B | Placebo comparator | Other: Tai chi chuan2 tai chi session per week during 2 month (M2 to M4) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient age > 18 years old with RA (ACR/EULAR criteria) in remission (CDAI ≤2.8) or with low disease activity (CDAI ≤10).
- Patient able to walk without help
- Patient able to complete a questionnaire
- Patient giving informed consent.
- Patient covered by social security
Key exclusion criteria (4 listed)
- Patient with disorder of higher mental function or psychiatric disorders.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai chi chuanTai 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. | Other | Control group B, interventional group A |
Primary outcome
Change in total physical activity time expressed in min/ day between M0 and M2 measured by eMouve smartphone application
Time frame: At Month 0 before the first session of tai chi and Month 2 after 16 sessions of tai chi (intervention group), measured at Month 0 and Month 2 (control group without tai chi).
Android application allows to estimate in usual conditions of life the energy expenditure and time spent in three intensities of physical activities: light, moderate and vigorous, as well as the time spent in sedentary behaviors. Android smartphone with application eMouve will be entrusted to patients to collect information from their physical activity (PA) for 4 days (2 days of the week and 2 days of weekend).
Change in total physical activity time expressed in MET.min/week between M0 and M2 measured by Global physical activity questionnaire (GPAQ Questionnaire (Global Physical Activity Questionnaire)
Time frame: At Month 0 before the first session of tai chi and Month 2 after 16 sessions of tai chi (intervention group), measured at Month 0 and Month 2 (control group without tai chi).
Modified Global Physical Activity Questionnaire provides a longitudinal assessment of a typical week for physical activity and sedentary behaviors. It covers three areas of activities: work activity, utilitarian travel, leisure activities and home-based activities. This questionnaire provides information on time spent on different activities in each of three areas mentioned above. A specific energy expenditure is associated with each PA, which makes it possible to estimate the overall energy expenditure of the patients. It also provides information on sedentary time.
8 secondary outcomes
Disease activity, evaluated by CDAI score (Clinical Disease Activity Index) at M0, at M2 after 16 sessions and at M4 after 32 sessions (interventional group) and evaluated at M0, M2 and M4 after 16 sessions (control group).
Time frame: at M0, M2 and M4 after 16 sessions
Sedentary time expressed in ME.min/week measured by modified Global Physical Activity Questionnaire.
Time frame: At Month 0, Month 2 after 16 sessions and at Month 4 after 32 sessions (interventional group) and measured at Month 0, Month 2 and Month 4 after 16 sessions (control group).
Physical activity time of light intensity, moderate intensity, high intensity measured by the modified GPAQ expressed in ME.minute/week
Time frame: At Month 0, at Month 2 after 16 sessions and at Month 4 after 32 sessions (interventional group) and measured at Month 0, Month 2 and Month 4 after sessions (control group).
Schober test
Time frame: At Month 0, at Month 2 after 16 sessions and at Month 4 after 32 sessions (group interventional) and measured at Month 0, Month 2 and Month 4 after 16 sessions (control group).
The single leg stance test
Time frame: At Month 0, at Month 2 after 16 sessions and at Month 4 after 32 sessions (group interventional) and measured at Month 0, Month 2 and Month 4 after 16 sessions (control group).
6 minutes walk test
Time frame: At Month 0, at Month 2 after 16 sessions and at Month 4 after 32 sessions (group interventional) and measured at Month 0, Month 2 and Month 4 after 16 sessions (control group).
Handgrip strengh test
Time frame: At Month 0, at Month 2 after 16 sessions and at Month 4 after 32 sessions (group interventional) and measured at Month 0, Month 2 and Month 4 after 16 sessions (control group).
Sit-to-stand test
Time frame: At Month 0, at Month 2 after 16 sessions and at Month 4 after 32 sessions (group interventional) and measured at Month 0, Month 2 and Month 4 after 16 sessions (control group).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Background: PubMed 25599350Biswas 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.
- Background: PubMed 25492375Cleland 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.
- Background: PubMed 27475271Ekelund 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.
- Background: PubMed 21540201Gossec 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.
- Background: PubMed 25048352Guidoux 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.
- Background: PubMed 28400313Guidoux 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.
- Background: PubMed 7473496Jones 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.
- Background: PubMed 22867933Uhlig 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.
- Background: PubMed 26219268Veldhuijzen 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.
- Background: PubMed 24033836Waite-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.
- Background: PubMed 23055009Wang 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.
- Background: PubMed 18487901Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin SOUBRIER, MD, PhD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai chi chuan in people with Rheumatoid Arthritis, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (04 73 75 49 63, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total physical activity time expressed in min/ day between M0 and M2 measured by eMouve smartphone application (time frame: At Month 0 before the first session of tai chi and Month 2 after 16 sessions of tai chi (intervention group), measured at Month 0 and Month 2 (control group without tai chi).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03678363, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.