Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. (FIMOUV 1)
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.
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Saint Etienne、法国、42055
- CHU Saint Etienne
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：纤维肌痛患者体力活动计划
在圣埃蒂安大学医院每周进行两次锻炼 1 个月，然后在卢瓦尔河 (42) 或上卢瓦尔河 (43) 的体育协会或俱乐部进行为期 2 个月的“运动健康”认证。
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Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified "Sports Health" in the Loire (42) or Haute-Loire (43) for 2 months.
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其他：纤维肌痛患者在家进行体力活动
在家进行体育锻炼的建议和建议（=当前的临床实践，每周自主进行 1 至 3 次）。
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在家进行体育锻炼的建议和建议（=当前的临床实践，每周自主进行 1 至 3 次）。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Assessment of the impact of a 3-month program
大体时间：at 3 months
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Health status assessed by the PGIC = Patient Global Impression of Change.
interpretation : 0= no change, 7= clear improvement, 5= better).
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at 3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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fatigue
大体时间：at 3 months
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assessed by Fatigue Severity Scale. This is a short questionnaire of 9 questions to which the patient answers on a scale from 1 to 7. Simply add the scores and divide by 9 - you get a result on 7 points. The higher the result, the greater the fatigue. Several studies speak of a threshold at 5.5 |
at 3 months
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Quality of sleep
大体时间：at 3 months
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assessed by the Pittsburgh. The questionnaire includes 19 self-assessment questions and 5 questions for the spouse or roommate (if any). Only self-assessment questions are included in the score. The 19 self-assessment questions combine to give 7 components" of the score with each component receiving a score of 0 to 3. In all cases, a score of 0 indicates that there is no difficulty while a score of 3 indicates the existence of severe difficulties. The 7 components of the score add up to give an overall score from 0 to 21 points, 0 meaning that there is no difficulty, and 21 indicating on the contrary major difficulties. |
at 3 months
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Anxiety and Depression
大体时间：at 3 months
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assessed by the Hospital Anxiety and Depression Scale (HADS) : An overall score of 19 or more indicates a major depressive episode.
An overall score of 13 corresponds to adjustment disorders and minor depression.
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at 3 months
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pain catastrophizing
大体时间：at 3 months
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assessed by the PCS (pain catastrophizing scale) assessing catastrophism : there are thirteen statements describing different thoughts and emotions that may be associated with pain. the person must indicate how painful these thoughts and emotions are.
From 0= not at all to 4 = all the time
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at 3 months
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pain evaluation
大体时间：at 3 months
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assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)
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at 3 months
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muscle power
大体时间：at 3 months
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evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.
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at 3 months
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muscular endurance
大体时间：at 3 months
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evaluated by dynamometry on a stress platform (arms and legs).
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at 3 months
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gas exchange measurement
大体时间：at 3 months
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evaluated during a stress test
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at 3 months
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quantification of physical activity in meter-h/week
大体时间：at 3 months
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evaluated by the APAQ : Adult Physical Activity Questionnaire
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at 3 months
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sedentary times in hours/day
大体时间：at 3 months
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evaluated by the APAQ : Adult Physical Activity Questionnaire
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at 3 months
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daily energy expenditure
大体时间：at 3 months
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evaluated by actimetry
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at 3 months
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time of physical activity
大体时间：at 3 months
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evaluated by actimetry
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at 3 months
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physical inactivity
大体时间：at 3 months
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evaluated by actimetry
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at 3 months
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patient adherence
大体时间：at 3, 6 and 12 months
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number of sessions performed
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at 3, 6 and 12 months
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Direct medical costs
大体时间：at 3, 6 and 12 months
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consultations, examinations, hospitalizations in euros
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at 3, 6 and 12 months
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Direct non-medical costs
大体时间：at 3, 6 and 12 months
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transport
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at 3, 6 and 12 months
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Cost of lost productivity
大体时间：at 3, 6 and 12 months
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time not worked
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at 3, 6 and 12 months
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合作者和调查者
调查人员
- 首席研究员：David HUPIN, MD、CHU de Saint Etienne
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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