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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A01120-43 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lyme Borreliosis with physical activity program | Experimental | 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 |
|
| Lyme Borreliosis patients with physical activity at home | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physical activity program | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Average level of moderate to vigorous physical activity (PA) - MET-h/week | MET = metabolic equivalent This is measured with actimetry (Actigraph GT3x, Pensacola, Florida, USA). | 1 year after implementation of the PA program |
| Measure | Description | Time Frame |
|---|---|---|
| average level of sedentary lifestyle (h/day) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David HUPIN, MD | Contact | 0477828413 | +33 | David.Hupin@chu-st-etienne.fr |
| Elisabeth BOTELHO-NEVERS, MD-PhD | Contact | 0477120762 | +33 | elisabeth.botelho-nevers@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| David HUPIN, MD | CHU de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Not yet recruiting | Clermont-Ferrand | 63000 | France |
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| Advice and recommendations of physical activity at home | Other | Advice and recommendations of physical activity at home (= current clinical practice in autonomy for 3 months). |
|
| Average level of moderate to vigorous physical activity (PA) - MET-h/week |
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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 |
| Chu Saint Etienne | Recruiting | Saint-Etienne | 42055 | France |
|
| ID | Term |
|---|---|
| D008193 | Lyme Disease |
| D009043 | Motor Activity |
| D020852 | Lyme Neuroborreliosis |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D001519 | Behavior |
| D020806 | Central Nervous System Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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