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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Average level of moderate to vigorous physical activity (PA) - MET-h/week [Срок оценки: 1 year after implementation of the PA program]

Вторичные конечные точки (9)

• average level of sedentary lifestyle (h/day) [Срок оценки: 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 [Срок оценки: at Month 3, Month 6 and Month 12 after implementation of the PA program]
• Average level of sedentary lifestyle (h/day) [Срок оценки: at Month 3, Month 6 and Month 12 after implementation of the PA program]
• VO2max (in ml/min/kg) [Срок оценки: at Month 3, Month 6 and Month 12 after implementation of the PA program]
• Biceps muscular strength (kg) [Срок оценки: at Month 3, Month 6 and Month 12 after implementation of the PA program]
• Patient Global Impression of Change (PGIC) [Срок оценки: at Month 3, Month 6 and Month 12 after implementation of the PA program]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: at Month 3, Month 6 and Month 12 after implementation of the PA program]
• Number of patients involved in the intervention [Срок оценки: at Month 6 after implementation of the PA program]
• medico-economic impact of the care organization [Срок оценки: at Month 12 after implementation of the PA program]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 2 центра

• CHU Clermont-Ferrand — Clermont-Ferrand
• Chu Saint Etienne — Saint-Etienne

Идентификаторы

NCT: NCT05641116 · 22CH398 · 2022-A01120-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗