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

NCT ID: NCT05641116

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-14
• Study Completion Date: 2027-12-31

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.

Conditions

Lyme Borreliosis; Physical Activity; Lyme Borreliosis, Nervous System

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Lyme Borreliosis with physical activity program

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

Group Type: EXPERIMENTAL

physical activity program

Intervention Type: 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).

Lyme Borreliosis patients with physical activity at home

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.

Group Type: OTHER

Advice and recommendations of physical activity at home

Intervention Type: OTHER

Advice and recommendations of physical activity at home (= current clinical practice in autonomy for 3 months).

Interventions

physical 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).

Intervention Type: OTHER

Advice and recommendations of physical activity at home

Advice and recommendations of physical activity at home (= current clinical practice in autonomy for 3 months).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David HUPIN, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint Etienne

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: NOT_YET_RECRUITING

Chu Saint Etienne

Saint-Etienne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

David HUPIN, MD

Role: CONTACT

David.Hupin@chu-st-etienne.fr

0477828413 ext. +33

Elisabeth BOTELHO-NEVERS, MD-PhD

Role: CONTACT

elisabeth.botelho-nevers@chu-st-etienne.fr

0477120762 ext. +33

Other Identifiers

2022-A01120-43

Identifier Type: OTHER

Identifier Source: secondary_id

22CH398

Identifier Type: -

Identifier Source: org_study_id