NCT02855801终止不适用
Exercise Training in Patients With Rheumatoid Arthritis and Cryotherapy: Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- plasma concentration of C-reactive protein
研究概览
简要总结
The main objective of this project is to study, in patients with rheumatoid arthritis, the effects of an intermittent type exercise associated with cryotherapy on the level of inflammation during its recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Men and women >18 years old, < 80 years old
- •Signature of informed consent for participation
- •Affiliation to a social security scheme or French beneficiary of such a regime.
- •confirmed rheumatoid arthritis and monitoring by the rheumatology department of the University Hospital of Besancon.
- •If there is a corticosteroid therapy, it must be stable for at least 1 month and less than or equal to 10 mg of prednisone equivalent per day
- •Clinical and biological activity will be moderate (ie not in remission and not severe based on Disease Activity Score 28 joints - DAS 28 - to be between 2 and 6
- •Patients could be treated with DMARDs (Disease-Modifying Drugs).
排除标准
- •Patient under guardianship, curatorship, under judicial protection, major incapable
- •Patients whose body mass index (BMI) greater than 30,
- •Pathology incompatible with the completion of a cycle ergometer exercise (heart, vascular, respiratory, orthopedic ...)
- •Change in DAS28 greater than 1.2 in the previous 3 months Inclusion
- •A patient with a DAS28 > 6
- •about the cold: Raynaud's syndrome, cold known allergy, sickle cell anemia, cryoglobulinemia, uncontrolled hypertension
- •Patient unable to follow protocol because of cognitive, psychiatric or language difficulties.
- •Inability to follow protocol for causes related to health problems (unrelated Rheumatoid Arthritis) or socio-professional.
研究组 & 干预措施
constant exercise with cryotherapy
Experimental
constant exercise with cryotherapy
干预措施: cryotherapy (Other)
intermittent exercise, no cryotherapy
Experimental
intermittent exercise without cryotherapy
干预措施: intermittent exercise (Other)
intermittent exercise and cryotherapy
Experimental
intermittent exercise with cryotherapy
干预措施: cryotherapy (Other)
intermittent exercise and cryotherapy
Experimental
intermittent exercise with cryotherapy
干预措施: intermittent exercise (Other)
constant exercise without cryotherapy
Experimental
constant exercise without cryotherapy
干预措施: constant exercise (Other)
constant exercise with cryotherapy
Experimental
constant exercise with cryotherapy
干预措施: constant exercise (Other)
结局指标
主要结局
plasma concentration of C-reactive protein
时间窗: 48 hours after the end of the exercise
次要结局
未报告次要终点
研究者
研究点 (1)
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