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

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Enrolling

Conditions

Lyme Borreliosis, Nervous System
Physical Activity
Lyme Borreliosis

Treatments

Other: physical activity program
Other: Advice and recommendations of physical activity at home

Study type

Interventional

Funder types

Other

Identifiers

NCT05641116
22CH398
2022-A01120-43 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

62 participants in 2 patient groups

Lyme Borreliosis with physical activity program
Experimental group
Description:
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
Treatment:
Other: physical activity program
Lyme Borreliosis patients with physical activity at home
Other group
Description:
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.
Treatment:
Other: Advice and recommendations of physical activity at home

Trial contacts and locations

2

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Central trial contact

Elisabeth BOTELHO-NEVERS, MD-PhD; David HUPIN, MD

Data sourced from clinicaltrials.gov

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