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

Physical Activity Clinical Trial

— LyMouv'  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05641116
• Other study ID #: 22CH398
• Secondary ID: 2022-A01120-43
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2023
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: David HUPIN, MD
• Phone: 0477828413
• Email: David.Hupin[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lyme Borreliosis
• Lyme Borreliosis, Nervous System
• Lyme Disease
• Lyme Neuroborreliosis
• Physical Activity

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	Chu Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	at Month 3, Month 6 and Month 12 after implementation of the PA program
Secondary	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.	at Month 3, Month 6 and Month 12 after implementation of the PA program
Secondary	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.	at Month 3, Month 6 and Month 12 after implementation of the PA program
Secondary	VO2max (in ml/min/kg)	This physical ability is measured with a cardiorespiratory test on a cycloergometer	at Month 3, Month 6 and Month 12 after implementation of the PA program
Secondary	Biceps muscular strength (kg)	Muscular strength will be assessed by biceps muscle strength (in kilograms) on the Handgrip (JAMAR Hand Dynamometer, UK)	at Month 3, Month 6 and Month 12 after implementation of the PA program
Secondary	Patient Global Impression of Change (PGIC)	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".	at Month 3, Month 6 and Month 12 after implementation of the PA program
Secondary	Hospital Anxiety and Depression Scale (HADS)	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.	at Month 3, Month 6 and Month 12 after implementation of the PA program
Secondary	Number of patients involved in the intervention	Assessment of adherence as measured by the number of patients involved in the intervention	at Month 6 after implementation of the PA program
Secondary	medico-economic impact of the care organization	Average cost saved per 100 patients treated in the "physical activity program group" compared to the "control group"	at Month 12 after implementation of the PA program