ライムボレリア症に起因する慢性症状を有する患者における適応身体活動と治療教育を組み合わせた介入の有効性。 (LyMouv')
ライムボレリア症に起因する慢性症状を有する患者における適応身体活動と治療教育を組み合わせた介入の有効性。多施設共同無作為化パイロット研究
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：David HUPIN, MD
- 電話番号：+33 0477828413
- メール：David.Hupin@chu-st-etienne.fr
研究連絡先のバックアップ
- 名前：Elisabeth BOTELHO-NEVERS, MD-PhD
- 電話番号：+33 0477120762
- メール：elisabeth.botelho-nevers@chu-st-etienne.fr
研究場所
-
-
-
Clermont-Ferrand、フランス、63000
- まだ募集していません
- CHU Clermont-Ferrand
-
主任研究者：
- Clémence RICHAUD, MD
-
副調査官：
- Clément THEIS, MD
-
Saint-Etienne、フランス、42055
- 募集
- Chu Saint Etienne
-
副調査官：
- BOTELHO-NEVERS Élisabeth, PhD
-
副調査官：
- CAZORLA Céline, MD
-
主任研究者：
- David HUPIN, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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). |
|
他の：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). |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Average level of moderate to vigorous physical activity (PA) - MET-h/week
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
average level of sedentary lifestyle (h/day)
時間枠：at Month 3, Month 6 and Month 12 after implementation of the PA program
|
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
時間枠：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
|
|
Average level of sedentary lifestyle (h/day)
時間枠：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
|
|
VO2max (in ml/min/kg)
時間枠：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)
時間枠：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)
時間枠：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
|
|
Hospital Anxiety and Depression Scale (HADS)
時間枠：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
時間枠：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
|
|
medico-economic impact of the care organization
時間枠：at Month 12 after implementation of the PA program
|
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
|
協力者と研究者
捜査官
- 主任研究者：David HUPIN, MD、CHU de Saint Etienne
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 22CH398
- 2022-A01120-43 (その他の識別子：ANSM)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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