Effectiveness of an Intervention Combining Adapted Physical Activity and Therapeutic Education in Patients With Chronic Symptoms Attributed to Lyme Borreliosis.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of an Intervention Combining Adapted Physical Activity and Therapeutic Education in Patients With Chronic Symptoms Attributed to Lyme Borreliosis. Multicenter, Controlled, Randomized Pilot Study

Conditions
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Lyme Borreliosis, Physical Activity, Lyme Borreliosis, Nervous System

Intervention / Treatment
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* Other: physical activity program
* Other: Advice and recommendations of physical activity at home


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lyme Borreliosis with physical activity program<br>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 | Other: physical activity program<br>* 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).<br>|
| Other: Lyme Borreliosis patients with physical activity at home<br>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. | Other: Advice and recommendations of physical activity at home<br>* Advice and recommendations of physical activity at home (= current clinical practice in autonomy for 3 months).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedentary time, therapeutic education of the patient, adapted physical activity, training program