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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Saint Etienne, 프랑스, 42055
- CHU Saint Etienne
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 신체 활동 프로그램이 있는 섬유근육통 환자
생테티엔 대학병원에서 1개월 동안 주 2회 운동한 다음 2개월 동안 Loire(42) 또는 Haute-Loire(43)에 있는 "Sports Health" 인증을 받은 스포츠 협회 또는 클럽 외부에서 릴레이합니다.
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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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다른: 집에서 신체활동을 하는 섬유근육통 환자
가정에서의 신체 활동에 대한 조언 및 권장 사항(= 현재 임상 실습, 자율적으로 주당 1~3회 세션).
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가정에서의 신체 활동에 대한 조언 및 권장 사항(= 현재 임상 실습, 자율적으로 주당 1~3회 세션).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Assessment of the impact of a 3-month program
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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fatigue
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: at 3 months
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evaluated by actimetry
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at 3 months
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physical inactivity
기간: at 3 months
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evaluated by actimetry
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at 3 months
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patient adherence
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: David HUPIN, MD, CHU de Saint Etienne
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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