NCT03548870尚未招募不适用
Effects of Transcutaneous Electrical Nerve Stimulation During Acute Aerobic Exercise in Patients With Chronic Obstructive Pulmonary Disease After Exacerbation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- comparison of exercise tolerance
研究概览
简要总结
Early pulmonary rehabilitation is recommended after an episode of severe exacerbation of chronic obstructive pulmonary disease (COPD). However, its implementation is challenging particularly as regard exercise training. Several studies showed that transcutaneous electrical nerve stimulation (TENS) could improve dyspnea and pulmonary function. The aim of this study is to assess the acute effect of TENS on exercise tolerance in post-exacerbation COPD patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
sham transcutaneous electrical nerve stimulation
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of COPD
排除标准
- •exercise contraindication Any musculoskeletal problems, cardiovascular or
- •neurological comorbidities that limits exercise.
- •pH < 7,35
- •Body temperature > 38°C
- •cardiac frequency > 100 bpm at rest
- •systolic blood pressure < 100 mmHg
- •exacerbation during the study
- •heart pace-maker or defibrillator
- •Opiate treatment during the last 3 months
研究组 & 干预措施
Test with TENS
Experimental
Patients will perform one Constant Work-Rate Exercise Test at 80% of maximum workload with low frequency TENS
干预措施: CWRT with low frequency transcutaneous electrical nerve stimulation (Other)
Test with sham-TENS
Sham Comparator
Patients will perform one Constant Work-Rate Exercise Test at 80% of maximum workload with low frequency sham-TENS
干预措施: CWRT with sham-low frequency transcutaneous electrical nerve stimulation (Other)
结局指标
主要结局
comparison of exercise tolerance
时间窗: two CWRET will be carried out in different days, separate from 24 hours minimum for a total time frame of 5 days maximum
Comparison of endurance time (Tlim, in second) during constant workload testing (CWRET) under 2 conditions
次要结局
- Difference in carbon dioxide production(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise)
- Difference in tidal volume(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise)
- Difference in inspiratory capacity(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise)
- Difference in Dyspnea(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise)
- Difference in Oxygen Saturation(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise)
- Difference in Cardiac Frequency(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise)
- Difference in peripheral muscle oxygenation(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise)
- Difference in muscular fatigue(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise)
- Difference in oxygen consumption(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise)
- Difference in minute ventilation(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise)
- Difference in respiratory rate(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise)
- Difference in respiratory quotient(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise)
研究者
研究点 (1)
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