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

NCT05641116 | Recruiting

• 2 other identifiers: 22CH3982022-A01120-43
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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.

Conditions

Lyme Borreliosis; Physical Activity; Lyme Borreliosis, Nervous System

Keywords

sedentary time; therapeutic education of the patient; adapted physical activity; training program

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• average level of sedentary lifestyle (h/day)

  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

  at Month 3, Month 6 and Month 12 after implementation of the PA program

• Average level of sedentary lifestyle (h/day)

  at Month 3, Month 6 and Month 12 after implementation of the PA program

• VO2max (in ml/min/kg)

  at Month 3, Month 6 and Month 12 after implementation of the PA program

• Biceps muscular strength (kg)

  at Month 3, Month 6 and Month 12 after implementation of the PA program

Study Arms (2)

Lyme Borreliosis with physical activity program

EXPERIMENTAL

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

Lyme Borreliosis patients with physical activity at home

OTHER

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

Interventions

physical activity program 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 with physical activity program

Advice and recommendations of physical activity at home OTHER

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

Lyme Borreliosis patients with physical activity at home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (2)

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

Chu Saint Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Lyme Disease; Motor Activity; Lyme Neuroborreliosis; Sedentary Behavior

Interventions

Counseling

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Behavior; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• David HUPIN, MD

  CHU de Saint Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David HUPIN, MD

CONTACT

0477828413; David.Hupin@chu-st-etienne.fr

Elisabeth BOTELHO-NEVERS, MD-PhD

CONTACT

0477120762; elisabeth.botelho-nevers@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: December 7, 2022
• Study Start: September 14, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)