Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. Interventional, Controlled, Randomized, Open Study of an Original Outpatient Management.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Assessment of the impact of a 3-month program
研究概览
简要总结
Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest.
The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest.
Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient lived in t Loire (42) or Haute-Loire (43)
- •Patient diagnosed with fibromyalgia according to ACR (American College of rheumatology) criteria (total score WPI (Widespread Pain Index) + SS (Severity Scale) ) ≥ 13
- •French writing and speaking
- •Sedentary or low level of activity (less than 2 hours of regular physical activity per week at the time of inclusion)
- •Signature of informed consent
排除标准
- •Cardiac or respiratory diseases that contraindicate the practice of physical activity
- •Significant co-morbidities that contraindicate the practice of physical activity: associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies (severe obstructive or severe respiratory insufficiency), disabling joint pathologies (knee osteoarthritis or osteoarthritis of the hip) training on a treadmill or on a high intensity bike).
- •Impossibility of submitting to the medical monitoring of the program for geographical, social or psychological reason
结局指标
主要结局
Assessment of the impact of a 3-month program
时间窗: at 3 months
Health status assessed by the PGIC = Patient Global Impression of Change. interpretation : 0= no change, 7= clear improvement, 5= better).
次要结局
- gas exchange measurement(at 3 months)
- time of physical activity(at 3 months)
- physical inactivity(at 3 months)
- muscular endurance(at 3 months)
- Direct medical costs(at 3, 6 and 12 months)
- sedentary times in hours/day(at 3 months)
- patient adherence(at 3, 6 and 12 months)
- Direct non-medical costs(at 3, 6 and 12 months)
- fatigue(at 3 months)
- Quality of sleep(at 3 months)
- pain evaluation(at 3 months)
- daily energy expenditure(at 3 months)
- muscle power(at 3 months)
- Anxiety and Depression(at 3 months)
- pain catastrophizing(at 3 months)
- quantification of physical activity in meter-h/week(at 3 months)
- Cost of lost productivity(at 3, 6 and 12 months)