Effectiveness of an Intervention Combining Adapted Physical Activity and Therapeutic Education in Patients With Chronic Symptoms Attributed to Lyme Borreliosis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: physical activity program, Advice and recommendations of physical activity at home.
- Who it may be relevant to
- Registry conditions: Lyme Borreliosis, Physical Activity, Lyme Borreliosis, Nervous System. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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 Advice and recommendations of physical activity at home
Advice and recommendations of physical activity at home (= current clinical practice in autonomy for 3 months).
Primary outcome measures
- Average level of moderate to vigorous physical activity (PA) - MET-h/week [Time frame: 1 year after implementation of the PA program]
Secondary outcome measures (9)
- average level of sedentary lifestyle (h/day) [Time frame: 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 [Time frame: at Month 3, Month 6 and Month 12 after implementation of the PA program]
- Average level of sedentary lifestyle (h/day) [Time frame: at Month 3, Month 6 and Month 12 after implementation of the PA program]
- VO2max (in ml/min/kg) [Time frame: at Month 3, Month 6 and Month 12 after implementation of the PA program]
- Biceps muscular strength (kg) [Time frame: at Month 3, Month 6 and Month 12 after implementation of the PA program]
- Patient Global Impression of Change (PGIC) [Time frame: at Month 3, Month 6 and Month 12 after implementation of the PA program]
- Hospital Anxiety and Depression Scale (HADS) [Time frame: at Month 3, Month 6 and Month 12 after implementation of the PA program]
- Number of patients involved in the intervention [Time frame: at Month 6 after implementation of the PA program]
- medico-economic impact of the care organization [Time frame: at Month 12 after implementation of the PA program]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 2 centers
- CHU Clermont-Ferrand — Clermont-Ferrand
- Chu Saint Etienne — Saint-Etienne
Identifiers
NCT: NCT05641116 · 22CH398 · 2022-A01120-43