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NCT Number: NCT05641116

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

  1. Average level of moderate to vigorous physical activity (PA) - MET-h/week

    Time frame: 1 year after implementation of the PA program

    MET = metabolic equivalent

    This is measured with actimetry (Actigraph GT3x, Pensacola, Florida, USA).

Secondary outcomes

  1. average level of sedentary lifestyle (h/day)

    Time frame: 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)

  2. Average level of moderate to vigorous physical activity (PA) - MET-h/week

    Time frame: 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.

  3. Average level of sedentary lifestyle (h/day)

    Time frame: 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.

  4. VO2max (in ml/min/kg)

    Time frame: 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

  5. Biceps muscular strength (kg)

    Time frame: 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)

  6. Patient Global Impression of Change (PGIC)

    Time frame: 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".

  7. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

  8. Number of patients involved in the intervention

    Time frame: at Month 6 after implementation of the PA program

    Assessment of adherence as measured by the number of patients involved in the intervention

  9. medico-economic impact of the care organization

    Time frame: 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"

Study contacts

Contact information is provided by the study sponsor or research team.

David HUPIN, MD

CONTACT

[email protected]

0477828413 ext. +33

Elisabeth BOTELHO-NEVERS, MD-PhD

CONTACT

[email protected]

0477120762 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study 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

Acronym: LyMouv'

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 7, 2022
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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