The Role of Moderate Aerobic Exercise as Determined by Cardiopulmonary Exercise Testing in ALS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Functional decline between start and end of the study
研究概览
简要总结
This study evaluated the influence of a tailored aerobic exercise protocol on the functional outcome in ALS patients. In addition, the investigators compare some CPET variables collected during exercise testing in both groups.
详细描述
This work aimed to evaluate the effects of a moderate aerobic exercise with controlled intensity determined by Cardiopulmonary Exercise Testing (CPET) and its role on the functional status in ALS patients versus standard care. Additionally, the investigators explored the performance of CPET variables - oxygen uptake (VO2) expressed in L/min, in percentage of predicted or in metabolic equivalents (METs) at peak effort, at anaerobic threshold (AT), the respiratory compensation point (RCP) when achieved, Dioxide Carbon output in L/min (VCO2) and the minute ventilation in L/min (VE) throughout the study.
Assessments:(diagnostic visit - T0), at study entry (T1) and 6 months after (T2) using:
Functional status by Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), Respiratory function tests (RFT): Forced Vital Capacity predicted (%FVC) and Oxygen saturation provided by pulse oximetry.
CPET was performed in both groups at study entry and 6 months later (T1 and T2), using a treadmill (WOODWAY®) coupled with a gas exchange analyzer (METALYZER® 3B) with ergo-spirometry system using a breath-by-breath technology developed by CORTEX® systems.
Intervention:
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
- Single (Outcomes Assessor)
盲法说明
single blinded
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients diagnosed with definite, probable, or probable laboratory supported ALS
- •Disease duration from first symptoms between 6-24 months to exclude slow and fast progression
- •ALSFRS-R ≥ 30
- •FVC (%predicted) ≥ 70%
排除标准
- •Other medical conditions, like cardiac insufficiency and lung disorders or others conditions limiting exercise training;
- •Heavy smoking habits with laboratorial evidence of significant bronchial constriction;
- •Signs of associated dementia or psychiatric disorders.
- •Note: None of the patients were on tube feeding, invasive or non-invasive mechanical ventilation at admission of study protocol (T1).
结局指标
主要结局
Functional decline between start and end of the study
时间窗: between baseline and 6 months later
It was used the Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R),which rates the functionality of the ALS patients in performing activities involving 4 different areas through 3 sub-scores - bulbar, spinal \[upper and lower limb\] and also the respiratory function. Each of its questions is rated from 0 (total inability) to 4 points (no functional limitation). The last three questions address the respiratory function (dyspnea, orthopnea, respiratory insufficiency) and assess the respiratory functional outcome. The sub-scores rating: Bulbar sub-score between 0 - 12, the spinal score between 0 - 24 and the respiratory sub-score between 0 - 12.The sum of the sub-scores provide an ALSFRS-R total score = 48. Higher values represent a better functionality.
次要结局
- Performance of Cardiopulmonary Exercise testing variables throughout the study(at study entry and 6 months later.)
- Changes on the Dioxide Carbon output (VCO2) measurement(at study entry and 6 months later)
- Changes on the Minute Ventilation (VE) measurement(at study entry and 6 months later)
研究者
Anna Caroline Braga
Investigator
University of Lisbon