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.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
62
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 (= current clinical practice in autonomy for 3 months).
CHU Clermont-Ferrand
Clermont-Ferrand, France
NOT_YET_RECRUITINGChu Saint Etienne
Saint-Etienne, France
RECRUITINGAverage level of moderate to vigorous physical activity (PA) - MET-h/week
MET = metabolic equivalent This is measured with actimetry (Actigraph GT3x, Pensacola, Florida, USA).
Time frame: 1 year after implementation of the PA program
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)
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
This measured with Adult Physical Activity Questionnaire (APAQ) Score from 0 to 21 points, 0 = no difficulty, and 21= major difficulties.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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".
Time frame: 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.
Time frame: 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
Time frame: 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"
Time frame: at Month 12 after implementation of the PA program
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.