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

Not Applicable

Recruiting

• Conditions: Lyme Borreliosis, Nervous System; Lyme Borreliosis; Physical Activity

• Registration Number: NCT05641116
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-29
• Study First Posted: 2022-12-07
• Study Start: 2023-09-14
• Status Verified: 2025-06
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-03
• Primary Completion: 2026-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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 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.
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.
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
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
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.
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".
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"

Trial Locations

Locations (2)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Chu Saint Etienne; 🇫🇷 Saint Etienne, France