Sport Therapy for Contrasting the Deterioration of Muscle Oxidative Metabolism in Patients Affected by Amyotrophic Lateral Sclerosis (ALS) - Project ME_E_SLA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- change in the relationship between maximal oxygen consumption (VO2max) and muscle oxygen extraction capacity at 12 weeks
研究概览
简要总结
This project assessed muscle oxidative metabolism and fatigue in patients affected by amyotrophic lateral sclerosis (ALS) undergoing to three months of individualized cardiovascular and strength training. Muscle oxidative metabolism and strength will be assessed by non-invasive methods, such as near-infrared spectroscopy (NIRS) and mechanomyography (MMG). NIRS is a technique giving indications on the capacity of oxygen extraction of muscles during exercise. MMG allows analyzing the pattern of motor unit recruitment and related fatigue. The investigators will also assess the effects of training on pain tolerance and quality of life (QoL) by the Brief Pain Inventory and the McGill Quality of Life questionnaires, using the validated Italian versions. Patients will be assessed longitudinally before (time T0) and after three months of individualized training (time T1). After one month of de-training (time T2) the investigators will assess the hypothetic persistence of any treatment-related effect. The effect of three months-osteopathic treatment (osteo) on pain and QoL will be assessed as well.
详细描述
Single blind pilot trial assessing the efficacy and side effects of active training or osteopathic manipulative treatment in ALS.
Interventions will be administered for three months (plus one month without intervention) by specialized personnel.
Primary outcome measures will include: exercise tolerance and muscle oxygen extraction capacity, side effects. Secondary outcome measures will include: pain, QoL and disease progression scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •diagnosis of ALS
- •early stages of disease
- •able to perform exercise with major muscle groups.
排除标准
- •non-invasive ventilation (NIV)
- •tracheostomy
- •coronaropathy
- •ongoing infectious diseases
- •cognitive deficits.
结局指标
主要结局
change in the relationship between maximal oxygen consumption (VO2max) and muscle oxygen extraction capacity at 12 weeks
时间窗: 12 weeks
exercise tolerance assessed by Cardio pulmonary Exercise Test (CPET); oxygen extraction on vastus lateralis, respiratory muscle and hand thenar eminence muscles assessed by Near Infrared Spectroscopy (NIRS)
appearance of side effects during the period of intervention administration
时间窗: 12 weeks
次要结局
- change of quality of life at 12 weeks(12 weeks)
- change of the neurological functional status at 12 weeks(12 weeks)
- change of pain at 12 weeks(12 weeks)