Effectiveness of an Intervention Combining Adapted Physical Activity and Therapeutic Education in Patients With Chronic Symptoms Attributed to Lyme Borreliosis. - Clinical Trial for Lyme Borreliosis | NCT05641116

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

physical activity program

Advice and recommendations of physical activity at home

About this trial

This is an interventional other trial for Lyme Borreliosis focused on measuring sedentary time, therapeutic education of the patient, adapted physical activity, training program

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

CHU Clermont-Ferrand
Chu Saint EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Lyme Borreliosis with physical activity program

Lyme Borreliosis patients with physical activity at home

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)

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.

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.

VO2max (in ml/min/kg)

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

Biceps muscular strength (kg)

Muscular strength will be assessed by biceps muscle strength (in kilograms) on the Handgrip (JAMAR Hand Dynamometer, UK)

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".

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.

Number of patients involved in the intervention

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

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"

Full Information

NCT ID

NCT05641116

First Posted

November 8, 2022

Last Updated

October 3, 2023

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

1. Study Identification

Unique Protocol Identification Number

NCT05641116

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 14, 2023 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lyme Borreliosis, Physical Activity, Lyme Borreliosis, Nervous System

Keywords

sedentary time, therapeutic education of the patient, adapted physical activity, training program

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lyme Borreliosis with physical activity program

Arm Type

Experimental

Arm Description

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

Arm Title

Lyme Borreliosis patients with physical activity at home

Arm Type

Other

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

physical activity program

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Advice and recommendations of physical activity at home

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

MET = metabolic equivalent This is measured with actimetry (Actigraph GT3x, Pensacola, Florida, USA).

Time Frame

1 year after implementation of the PA program

Secondary Outcome Measure Information:

Title

average level of sedentary lifestyle (h/day)

Description

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