Exercise traiNing in Amyotrophic Lateral Sclerosis: a ranDomized Trial Comparing Home-based Aerobic endUrance tRAiNing vs. Usual physiCal Therapy intErvention
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline in peak oxygen consumption (peak VO2)
研究概览
简要总结
The purpose of this study is to compare the safety and the effects of moderate-intensity aerobic endurance training to those of an usual physical therapy intervention on exercise capacity and quality of life in patients with amyotrophic lateral sclerosis (ALS).
详细描述
Scarce evidence is available regarding aerobic exercise training of patients with ALS. Some studies using transgenic mouse models of familial ALS have shown markedly slowed disease progression, improved functional capacity, and extension of survival in animals undergoing aerobic exercise training. In humans, only one non-randomized study has shown that moderate-intensity aerobic exercise training was of little beneficial effect in a small group of patients with Kennedy disease, a rare X-linked progressive neuromuscular disease involving lower motorneurons, presenting a pathophysiological picture quite different from that of ALS. To the best of our knowledge, the safety and the effects of aerobic exercise training on functional capacity and quality of life of patients with ALS have not been systematically evaluated as yet in a randomized, controlled trial with an adequate sample size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of definite ALS, probable ALS, or probable-laboratory supported ALS according to the El Escorial criteria or diagnosis of progressive muscular atrophy.
- •Ability to perform a baseline symptom-limited cardiopulmonary exercise test with attainment of peak power and respiratory exchange ratio of >= 50 W and >= 1.00, respectively.
- •Time since symptoms onset <= 18 months.
- •Forced vital capacity >= 70% of predicted.
- •Informed written consent.
排除标准
- •Coexisting neurological disease.
- •Coexisting extra-neurological disease significantly affecting exercise capacity.
- •Coexisting malignancy.
- •Ongoing/planned pregnancy.
- •Involvement in formal endurance and/or strength training program.
- •Enrolment in any other clinical trial.
- •Cognitive impairment.
结局指标
主要结局
Change from baseline in peak oxygen consumption (peak VO2)
时间窗: 3 months
Evaluate the effects of aerobic training on peak VO2, as assessed by cardiopulmonary exercise testing
次要结局
- Aerobic training safety and tolerability(3 months)
- Change from baseline in quality of life(3 months)
- Change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) score(3 months)
- Change from baseline in lower limbs muscle strength(3 months)
- Change from baseline in upper and lower motor neurons function at the upper and lower limbs level(3 months)
- Change from baseline in ventilatory function(3 months)
- Change from baseline in circulating inflammatory markers, growth factors and descriptors of skeletal muscle damage(3 months)
研究者
Alessandro Mezzani
MD, FESC
Fondazione Salvatore Maugeri