Effect of Argentine Tango Protocol on Total Physical Activity in Patients With Chronic Inflammatory Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change in total physical activity time
研究概览
简要总结
The hypothesis is that pleasure brought by argentine tango practice would increase total physical activity of patients with chronic inflammatory arthritis.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
no masking
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
interventional group A
2 tango session per week during 6 month (M0 to M6)
干预措施: Argentine tango (Other)
Control group B
2 tango session per week during 3 month (M3 to M6)
干预措施: Argentine tango (Other)
结局指标
主要结局
Change in total physical activity time
时间窗: between month 0 and month3
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.
次要结局
- 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)