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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Average level of moderate to vigorous physical activity (PA) - MET-h/week
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Average level of moderate to vigorous physical activity (PA) - MET-h/week
时间窗: 1 year after implementation of the PA program
MET = metabolic equivalent This is measured with actimetry (Actigraph GT3x, Pensacola, Florida, USA).
次要结局
- Biceps muscular strength (kg)(at Month 3, Month 6 and Month 12 after implementation of the PA program)
- average level of sedentary lifestyle (h/day)(at Month 3, Month 6 and Month 12 after implementation of the PA program)
- Average level of sedentary lifestyle (h/day)(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(at Month 3, Month 6 and Month 12 after implementation of the PA program)
- Number of patients involved in the intervention(at Month 6 after implementation of the PA program)
- VO2max (in ml/min/kg)(at Month 3, Month 6 and Month 12 after implementation of the PA program)
- Hospital Anxiety and Depression Scale (HADS)(at Month 3, Month 6 and Month 12 after implementation of the PA program)
- Patient Global Impression of Change (PGIC)(at Month 3, Month 6 and Month 12 after implementation of the PA program)
- medico-economic impact of the care organization(at Month 12 after implementation of the PA program)