라임 보렐리아증에 기인한 만성 증상을 가진 환자에서 적응된 신체 활동과 치료 교육을 결합한 중재의 효과. (LyMouv')
라임 보렐리아증에 기인한 만성 증상을 가진 환자에서 적응된 신체 활동과 치료 교육을 결합한 중재의 효과. 다기관 통제 무작위 파일럿 연구
Lyme borreliosis, commonly known as Lyme disease, has been clinically described for more than a century, but has been officially recognized for 40 years, with the detection of the Borrelia bacterium by W. Burgdorfer, in ticks of the Ixodes ricinus complex, identified a few years before.
연구 개요
상태
상세 설명
Apart from the early localized presentation, with a well established treatment, Lyme borreliosis is a complex infection. Indeed, its presentation can be late and very polymorphic, which can evoke functional somatic disorders and make its management difficult. In 2016, the French Ministry of Health decided to launch a national plan to fight Lyme borreliosis. One of the objectives of this national plan was to improve management based on a specific multidisciplinary care pathway.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: David HUPIN, MD
- 전화번호: +33 0477828413
- 이메일: David.Hupin@chu-st-etienne.fr
연구 연락처 백업
- 이름: Elisabeth BOTELHO-NEVERS, MD-PhD
- 전화번호: +33 0477120762
- 이메일: elisabeth.botelho-nevers@chu-st-etienne.fr
연구 장소
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-
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Clermont-Ferrand, 프랑스, 63000
- 아직 모집하지 않음
- CHU Clermont-Ferrand
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수석 연구원:
- Clémence RICHAUD, MD
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부수사관:
- Clément THEIS, MD
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Saint-Etienne, 프랑스, 42055
- 모병
- Chu Saint Etienne
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부수사관:
- BOTELHO-NEVERS Élisabeth, PhD
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부수사관:
- CAZORLA Céline, MD
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수석 연구원:
- David HUPIN, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient referred to the reference center for tick-borne diseases by his attending physician
- Duration of symptoms >6 months
- At the end of the initial assessment, the diagnosis of functional somatic disorders is retained after consensus between the physicians
- Patient practicing less than 150 minutes of regular physical activity per week (WHO recommendations)
Exclusion Criteria:
- Patients with cardiac or respiratory pathologies that contraindicate the practice of physical activity physical activity
- Important comorbidities contraindicating the practice of physical activity: associated cardiac pathologies associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies respiratory pathologies (obstructive or severe restrictive respiratory insufficiency), disabling joint pathologies joint pathologies (gonarthrosis or coxarthrosis limiting training on a treadmill or on a high-intensity bicycle). intensity cycling).
- Patients under guardianship or curatorship
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 |
|---|---|
|
실험적: Lyme Borreliosis with physical activity program
Referral of the patient to the sport-health center of his department by the investigating physician (in connection with the attending physician for the prescription of Adaptive Physical Activity): for 24 sessions of APA for 3 months at a rate of 2 sessions/week at the sport and health center + 9 sessions of Therapeutic Patient Education in telecare |
24 face-to-face APA sessions at the sport and health center for 3 months at a rate of 2 sessions per week near his home and 9 therapeutic patient education workshops for 3 months at a rate of 3 workshops per month (telecare). |
|
다른: Lyme Borreliosis patients with physical activity at home
routine clinical practice : encouragement by the attending physician to modify lifestyle habits with advice on resuming regular physical activity independently and combating sedentariness. At home, in autonomy for 3 months. |
Advice and recommendations of physical activity at home (= current clinical practice in autonomy for 3 months). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Average level of moderate to vigorous physical activity (PA) - MET-h/week
기간: 1 year after implementation of the PA program
|
MET = metabolic equivalent This is measured with actimetry (Actigraph GT3x, Pensacola, Florida, USA). |
1 year after implementation of the PA program
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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average level of sedentary lifestyle (h/day)
기간: at Month 3, Month 6 and Month 12 after implementation of the PA program
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This is measured with actimetry (Actigraph GT3x, Pensacola, Florida, USA). The average sedentary time measured in industrialized countries is about 4 hours per day (excluding time spent sitting at work and in transport) |
at Month 3, Month 6 and Month 12 after implementation of the PA program
|
|
Average level of moderate to vigorous physical activity (PA) - MET-h/week
기간: at Month 3, Month 6 and Month 12 after implementation of the PA program
|
This measured with Adult Physical Activity Questionnaire (APAQ) Score from 0 to 21 points, 0 = no difficulty, and 21= major difficulties. |
at Month 3, Month 6 and Month 12 after implementation of the PA program
|
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Average level of sedentary lifestyle (h/day)
기간: at Month 3, Month 6 and Month 12 after implementation of the PA program
|
This measured with Adult Physical Activity Questionnaire (APAQ) Score from 0 to 21 points, 0 = no difficulty, and 21= major difficulties. |
at Month 3, Month 6 and Month 12 after implementation of the PA program
|
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VO2max (in ml/min/kg)
기간: at Month 3, Month 6 and Month 12 after implementation of the PA program
|
This physical ability is measured with a cardiorespiratory test on a cycloergometer |
at Month 3, Month 6 and Month 12 after implementation of the PA program
|
|
Biceps muscular strength (kg)
기간: at Month 3, Month 6 and Month 12 after implementation of the PA program
|
Muscular strength will be assessed by biceps muscle strength (in kilograms) on the Handgrip (JAMAR Hand Dynamometer, UK) |
at Month 3, Month 6 and Month 12 after implementation of the PA program
|
|
Patient Global Impression of Change (PGIC)
기간: at Month 3, Month 6 and Month 12 after implementation of the PA program
|
Health status will be assessed by the Patient Global Impression of Change (PGIC) and measured on a 7-point Likert scale, rated from 1 for "much worse" to 7 for "much better". |
at Month 3, Month 6 and Month 12 after implementation of the PA program
|
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Hospital Anxiety and Depression Scale (HADS)
기간: at Month 3, Month 6 and Month 12 after implementation of the PA program
|
Psychological distress will be assessed using the Hospital Anxiety and Depression Scale (HADS) The HADS scale has 14 items scored from 0 to 3. 7 questions concern anxiety and 7 others the depressive dimension, which makes it possible to obtain two scores (maximum score for each score = 21). A score greater than or equal to 11 means that the anxiety or depression is anxiety or depression is certain. |
at Month 3, Month 6 and Month 12 after implementation of the PA program
|
|
Number of patients involved in the intervention
기간: at Month 6 after implementation of the PA program
|
Assessment of adherence as measured by the number of patients involved in the intervention |
at Month 6 after implementation of the PA program
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medico-economic impact of the care organization
기간: at Month 12 after implementation of the PA program
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Average cost saved per 100 patients treated in the "physical activity program group" compared to the "control group" |
at Month 12 after implementation of the PA program
|
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 (추정된)
연구 완료 (추정된)
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
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 22CH398
- 2022-A01120-43 (기타 식별자: ANSM)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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