Effect of Tai Chi Protocol on Global Physical Activity in Patients With Spondyloarthitis in Comparison With a Control Group
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in global physical activity time per week, Global Physical Activity Questionnaire
研究概览
简要总结
Our hypothesis is that tai chi sessions would increase physical activity of patients with Spondyloarthitis. The main objective is to study the effect of tai chi sessions (16 vs.0) on global physical activity of Spondyloarthitis patients, compared to a control group without tai chi.
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: 32 sessions (on average 2/week) performed from M0 to M4 in 15 patients.
- Control "B" group: 16 sessions (on average 2/week) performed from M2 to M4 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 at M0, M2 and at the end of the protocol at M4.
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.
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
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 Spondyloarthitis (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 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
研究组 & 干预措施
interventional group A
2 tai chi session per week during 4 month (M0 to M4)
干预措施: Tai Chi 4 month (Other)
Control group B
2 tai chi session per week during 2 month (M2 to M4)
干预措施: Tai Chi 2 month (Other)
结局指标
主要结局
Change in global physical activity time per week, Global Physical Activity Questionnaire
时间窗: Month 2
measured by modified Global Physical Activity Questionnaire (GPAQ) .
Change in global physical activity time per week, measured by an accelerometer
时间窗: Month 2
measured by an accelerometer between M0 and M2 expressed in MET.min/week.
次要结局
- Change in Physical activity time of light intensity, moderate intensity, high intensity(Month 4)
- Change in Sedentary time(Month 4)