Clinical trial NCT05641116: Effectiveness of an Intervention Combining Adapted Physical Activity and Therapeutic Education in Patients With Chronic Symptoms Attributed to Lyme Borreliosis.
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lyme Borreliosis
Physical Activity
Lyme Borreliosis, Nervous System
Keywords: sedentary time
therapeutic education of the patient
adapted physical activity
training program
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average level of moderate to vigorous physical activity (PA) - MET-h/week
timeFrame: 1 year after implementation of the PA program
Secondary outcomes:
measure: average level of sedentary lifestyle (h/day)
timeFrame: at Month 3, Month 6 and Month 12 after implementation of the PA program
measure: Average level of moderate to vigorous physical activity (PA) - MET-h/week
timeFrame: at Month 3, Month 6 and Month 12 after implementation of the PA program
measure: Average level of sedentary lifestyle (h/day)
timeFrame: at Month 3, Month 6 and Month 12 after implementation of the PA program
measure: VO2max (in ml/min/kg)
timeFrame: at Month 3, Month 6 and Month 12 after implementation of the PA program
measure: Biceps muscular strength (kg)
timeFrame: at Month 3, Month 6 and Month 12 after implementation of the PA program
measure: Patient Global Impression of Change (PGIC)
timeFrame: at Month 3, Month 6 and Month 12 after implementation of the PA program
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: at Month 3, Month 6 and Month 12 after implementation of the PA program
measure: Number of patients involved in the intervention
timeFrame: at Month 6 after implementation of the PA program
measure: medico-economic impact of the care organization
timeFrame: at Month 12 after implementation of the PA program
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Saint Etienne
country: France
facility: Chu Saint Etienne
Study officials:
affiliation: CHU de Saint Etienne
name: David HUPIN, MD
role: PRINCIPAL_INVESTIGATOR
References: