Lyme BorreliosisLyMouv'NCT05641116
Effectiveness of an Intervention Combining Adapted Physical Activity and Therapeutic Education in Patients With Chronic Symptoms Attributed to Lyme Borreliosis.
A study testing physical activity program and Advice and recommendations of physical activity at home in people with Lyme Borreliosis and Physical Activity, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lyme Borreliosis, Physical Activity, Lyme Borreliosis, Nervous System
- What is being tested?
- physical activity program and Advice and recommendations of physical activity at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Sep 2023to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Elisabeth BOTELHO-NEVERS, MD-PhD contact
France2 sites, 2 recruiting
- Not yet recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Clémence RICHAUD, MD
Clément THEIS, MD
- Recruiting
Chu Saint Etienne
Saint-Etienne, 42055
BOTELHO-NEVERS Élisabeth, PhD
CAZORLA Céline, MD
About this study
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
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.
Read the 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.
- Being tested
- physical activity program, Advice and recommendations of physical activity at home
- Keywords
- sedentary time, therapeutic education of the patient, adapted physical activity, training program
- Medical subject headings
- Lyme Disease, Motor Activity, Lyme Neuroborreliosis, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activity programOther
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 homeOther
Advice and recommendations of physical activity at home (= current clinical practice in autonomy for 3 months).
| Study group | Role | What they receive |
|---|---|---|
| Lyme Borreliosis with physical activity program | Experimental | 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 Receives: Other: physical activity program |
| Lyme Borreliosis patients with physical activity at home | Other | 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. Receives: Other: Advice and recommendations of physical activity at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year after implementation of the PA program
Secondary outcomes (9)
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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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".
Measured: 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.
Measured: 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
Measured: 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"
Measured: at Month 12 after implementation of the PA program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start14 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme BorreliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David HUPIN, MD, Principal investigator, CHU de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641116
- Sponsor's protocol ID
- 22CH398
- Other IDs
- 2022-A01120-43
- Acronym
- LyMouv'
- Status last verified
- Sep 2026
- First submitted
- 8 Nov 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No