Effects of Lumbar Transcutaneous Electrical Nerve Stimulation on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease : A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Comparison of endurance time (Tlim, in second) during constant workload testing (CWT) under 3 conditions.
研究概览
简要总结
Chronic obstructive pulmonary disease is a leading cause of morbidity and mortality worldwide.
Pulmonary rehabilitation effectively improves outcomes in patients with chronic respiratory disease. There is a link between training intensity and physiological improvements following pulmonary rehabilitation. However, high intensity training is not sustainable for every patients.
Therefore, actual strategies for pulmonary rehabilitation aimed at decreasing dyspnea to improve muscle work.
Electrical muscle stimulation is widely used during rehabilitation to promote muscle function recovery. Transcutaneous electrical nerve stimulation was recently used to relief dyspnea and improve pulmonary function in patients with chronic respiratory disease. Moreover, spinal anesthesia with fentanyl has been shown to be effective in improving exercise tolerance in patients with chronic obstructive pulmonary disease (inhibiting group III and IV muscle afferents). As transcutaneous electrical muscle stimulation stimulates the same receptors in the spinal cord dorsal horn as fentanyl, it is hypothesized that it could also improve exercise capacity.
Therefore, the aim of this study is to assess wether transcutaneous electrical stimulation (high or low frequency) is effective in improving exercise capacity in patients with severe to very severe chronic obstructive pulmonary disease.
详细描述
Design : cross-over.
Patients will perform three constant workload testing (CWT) on different days under three different conditions. The intervention during the tests will be randomly assigned (concealed allocation) :
- Sham transcutaneous electrical nerve stimulation ;
- High-frequency transcutaneous electrical nerve stimulation ;
- Low-frequency transcutaneous electrical nerve stimulation.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Sham placebo will be used to blind patient. The outcome assessor will be invited to join the room after the experimental condition is installed.
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
- •Age > 18 years;
- •Chronic obstructive pulmonary disease Gold III-IV;
- •Eligible for pulmonary rehabilitation;
- •Never used electrical stimulation.
- •Non-inclusion Criteria:
- •Pregnant woman or likely to be;
- •Patient under guardianship;
- •History of epilepsy, heart pace-maker or defibrillator, inguinal or abdominal hernia;
- •Recent lumbar surgery or skin lesion;
- •Allergy to surface electrodes;
- •Lumbar sensitivity impairment;
- •Opiate treatment during the last 3 months.
排除标准
- •Acute exacerbation of chronic obstructive pulmonary disease
研究组 & 干预措施
CWT with high-frequency electrical nerve stimulation
This study has a cross-over design. Patients will achieve CWT with either sham, high-frequency or low-frequency lumbar transcutaneous electrical nerve stimulation in a randomised order.
干预措施: High-frequency transcutaneous electrical nerve stimulation (Other)
CWT with low-frequency electrical nerve stimulation
This study has a cross-over design. Patients will achieve CWT with either sham, high-frequency or low-frequency lumbar transcutaneous electrical nerve stimulation in a randomised order.
干预措施: Low-frequency transcutaneous electrical nerve stimulation (Other)
CWT with sham electrical nerve stimulation
This study has a cross-over design. Patients will achieve CWT with either sham, high-frequency or low-frequency lumbar transcutaneous electrical nerve stimulation in a randomised order.
干预措施: Sham transcutaneous electrical nerve stimulation (Other)
结局指标
主要结局
Comparison of endurance time (Tlim, in second) during constant workload testing (CWT) under 3 conditions.
时间窗: The outcome will be measured after every CWT. Data will be continuously collected during the tests. The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
Patients will achieve 3 constant workload testing under 3 different conditions (sham lumbar transcutaneous electrical nerve stimulation, high-frequency lumbar electrical nerve stimulation and low-frequency lumbar transcutaneous electrical nerve stimulation). Endurance time (sec) will be recorded at the end of every test. Endurance time will be compared to assess how the condition will influence exercice performance.
次要结局
- Oxygen saturation (SpO2, %) during CWT.(The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected)
- Exhaustion during CWT using modified Borg Scale (0-10).(The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be collected every 30s during tests.])
- Variation of total hemoglobin (THb) using near infra red spectroscopy.(The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected)
- Intensity of electrical stimulation (mA) reached during every CWT.(The outcome will be measured after every CWT. The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected)
- Dyspnea during CWT using modified Borg Scale (0-10).(The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be collected every 30s during tests)
- Heart rate (rpm) during CWT.(The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected)
- Blood pressure (mmHg) before and after every CWT.(The outcome will be assessed before and after every CWT. The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.)
- O2 consumption (VO2, mL/kg/min) during CWT.(The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected)
- Exercise ventilation (VE, L/min) during CWT.(The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected)
- Tidal Volume (Vt, L) during CWT.(The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected)
- Variation of total desoxy-hemoglobin (HHb) using near infra red spectroscopy.(The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected)
- Respiratory Rate (RR, rpm) during CWT.(The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected)
- Variation of total oxy-hemoglobin (HbO2) using near infra red spectroscopy.(The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected)