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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05641116

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lyme Borreliosis Physical Activity Lyme Borreliosis, Nervous System	Other: physical activity program Other: Advice and recommendations of physical activity at home	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official 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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Other: 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).
Other: 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.	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).

Arm

Intervention/Treatment

Experimental: 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

Other: 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).

Other: 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.

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).

Outcome Measures

Primary Outcome Measures

Average level of moderate to vigorous physical activity (PA) - MET-h/week [1 year after implementation of the PA program]
MET = metabolic equivalent This is measured with actimetry (Actigraph GT3x, Pensacola, Florida, USA).

Secondary Outcome Measures

average level of sedentary lifestyle (h/day) [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)
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]
This measured with Adult Physical Activity Questionnaire (APAQ) Score from 0 to 21 points, 0 = no difficulty, and 21= major difficulties.
Average level of sedentary lifestyle (h/day) [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.
VO2max (in ml/min/kg) [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
Biceps muscular strength (kg) [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)
Patient Global Impression of Change (PGIC) [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".
Hospital Anxiety and Depression Scale (HADS) [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.
Number of patients involved in the intervention [at Month 6 after implementation of the PA program]
Assessment of adherence as measured by the number of patients involved in the intervention
medico-economic impact of the care organization [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"

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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