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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • physical activity program

    Other intervention

    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 intervention

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

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Lyme Borreliosis with physical activity programExperimental treatment 1 intervention
Group B: Lyme Borreliosis patients with physical activity at homeOther 1 intervention

Trial outcomes

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).

Time frame
1 year after implementation of the PA program

Secondary outcomes

1

average level of sedentary lifestyle (h/day)

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)

Time frame
at Month 3, Month 6 and Month 12 after implementation of the PA program
2

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

This measured with Adult Physical Activity Questionnaire (APAQ) Score from 0 to 21 points, 0 = no difficulty, and 21= major difficulties.

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

Average level of sedentary lifestyle (h/day)

This measured with Adult Physical Activity Questionnaire (APAQ) Score from 0 to 21 points, 0 = no difficulty, and 21= major difficulties.

Time frame
at Month 3, Month 6 and Month 12 after implementation of the PA program
4

VO2max (in ml/min/kg)

This physical ability is measured with a cardiorespiratory test on a cycloergometer

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.