Lyme Borreliosis, Lyme Borreliosis, Nervous System, Physical Activity
Conditions
Keywords
sedentary time, therapeutic education of the patient, adapted physical activity, training program
Brief summary
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
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.
Interventions
OTHERphysical activity program
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).
Advice and recommendations of physical activity at home (= current clinical practice in autonomy for 3 months).
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average level of moderate to vigorous physical activity (PA) - MET-h/week | 1 year after implementation of the PA program | MET = metabolic equivalent This is measured with actimetry (Actigraph GT3x, Pensacola, Florida, USA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Change (PGIC) | 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. |
| average level of sedentary lifestyle (h/day) | 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) |
| Average level of moderate to vigorous physical activity (PA) - MET-h/week | 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. |
| Average level of sedentary lifestyle (h/day) | 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. |
| VO2max (in ml/min/kg) | 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 |
| Biceps muscular strength (kg) | 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) |
| Hospital Anxiety and Depression Scale (HADS) | 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. |
| Number of patients involved in the intervention | at Month 6 after implementation of the PA program | Assessment of adherence as measured by the number of patients involved in the intervention |
| medico-economic impact of the care organization | 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 |
Countries
France
Contacts
Primary ContactDavid HUPIN, MD
Backup ContactElisabeth BOTELHO-NEVERS, MD-PhD
Outcome results
None listed