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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Physical Activity; Lyme Borreliosis; Lyme Borreliosis, Nervous System
• Intervention / Treatment: Other: physical activity program; Other: Advice and recommendations of physical activity at home

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 Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David HUPIN, MD; Phone Number: +33 0477828413; Email: David.Hupin@chu-st-etienne.fr
• Study Contact Backup: Name: Elisabeth BOTELHO-NEVERS, MD-PhD; Phone Number: +33 0477120762; Email: elisabeth.botelho-nevers@chu-st-etienne.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Not yet recruiting
    • CHU Clermont-Ferrand
    • Principal Investigator: Léo SAUVAT, MD
  • Saint Etienne, France, 42055
    • Recruiting
    • CHU Saint Etienne
    • Sub-Investigator: BOTELHO-NEVERS Élisabeth, PhD
    • Sub-Investigator: CAZORLA Céline, MD
    • Principal Investigator: David HUPIN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: David HUPIN, MD, CHU de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: sedentary time; therapeutic education of the patient; adapted physical activity; training program
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Central Nervous System Bacterial Infections; Tick-Borne Diseases; Spirochaetales Infections; Lyme Disease; Borrelia Infections; Lyme Neuroborreliosis
• Other Study ID Numbers: 22CH398; 2022-A01120-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No