Rehabilitation of Patients With COPD Using Electrical Muscle Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Incremental Shuttle Walk Test (SWT)
研究概览
简要总结
The two hypotheses to be tested in this study are that:
- The administration of transcutaneous electrical muscle stimulation (TCEMS) after completion of conventional exercise training in pulmonary rehabilitation (PR) will result in further improvements in exercise tolerance, functional status and symptoms of patients with stable chronic obstructive pulmonary disease (COPD) above those achieved in PR alone.
- TCEMS can improve exercise tolerance, functional status and symptoms even among COPD patients who fail to make gains in exercise tolerance by participating in conventional PR due to their debilitation and/or marked cardio-respiratory impairment.
详细描述
Although a substantial body of evidence supports the existence of skeletal muscle dysfunction in COPD and the benefits of PR for these patients, the role of TCEMS as a routine rehabilitative strategy for patients with COPD has yet to be established. The studies proposed in this research will build on the knowledge gained in our previous study of TCEMS by investigating whether and how TCEMS adds to the beneficial effects of PR on exercise capacity and muscle function among outpatients with stable COPD, and by assessing for the first time whether TCEMS improves exercise tolerance and functional status among COPD patients unable to make gains following conventional outpatient PR. Thus, this proposed study may provide a novel strategy in the rehabilitation of patients with chronic lung disease.
The two specific aims of the proposed study are:
- Determine whether administration of TCEMS after conventional exercise training in PR leads to added gains in muscle strength, exercise capacity, dyspnea and health status, to determine if TCEMS should be considered as an additional routine method in outpatient PR programs.
- Determine whether patients who are unable to improve exercise tolerance during conventional exercise training in PR can achieve gains in muscle strength, exercise tolerance, dyspnea, and health status following TCEMS used as an alternate rehabilitative strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pulmonary function test criteria consistent with a diagnosis of COPD including forced expiratory volume in one second (FEV1) < 65% of predicted, with FEV1/FVC (forced vital capacity) ratio < 70%, lung hyperinflation based on a residual volume to total lung capacity (RV/TLC) ratio > 120% predicted and reduced diffusing capacity for carbon monoxide (DLCO <70% predicted).
- •Self-reported exercise limitation despite pharmacologic treatment.
- •Otherwise medically stable.
- •Women and minorities will also be recruited. Only persons able to give fully informed consent will be enrolled in the study.
排除标准
- •Patients will be excluded from study participation if they have a history of uncontrolled cardiovascular disease (including ventricular arrhythmia, myocardial infarction within 1 year, unstable angina, cardiac pacemaker or other implanted electrical device, other uncontrolled arrhythmias, or unstable blood pressure), neuromuscular disease (including stroke), debilitating joint disease or amputations that precludes exercise or have other contraindications to participating in outpatient PR (including unstable bone fracture, syncope of unclear etiology or cancer undergoing active chemotherapy), or are pregnant. Persons with a history of seizure disorder, intracranial clips or skin problems that would prevent safe or proper placement of the electrodes needed for electrical stimulation of the leg muscles will be excluded, based on prior clinical studies of TCEMS in non-COPD populations. Patients will also be excluded from study participation if they have undergone formal PR within 1 year of the date of study inclusion. No patients will be recruited from a "vulnerable patient population", including economically or educationally disadvantaged or mentally disabled persons, children, or prisoners.
结局指标
主要结局
Incremental Shuttle Walk Test (SWT)
时间窗: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
The incremental Shuttle Walk Test will be used as a measure of exercise capacity. This test measures the maximal distance walked by the patient around two position markers set 10 meters apart, at a pace set by audio signals from a cassette tape. Minute-by-minute walking speed is increased until the patient feels too tired or short of breath to continue, or is unable to walk at least half of the 10 meter distance by the time the next audio signal is heard. Patients who routinely use supplemental oxygen will perform the test while carrying their portable oxygen delivery system during testing. As noted above, a practice run will be performed on the day the patient comes in for familiarization with the protocol and equipment. The investigator conducting the Shuttle Walk Test will be blinded to the groupings of subjects to avoid potential bias of the results.
次要结局
- Pulmonary Function(Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS)
- Chronic Respiratory Disease Questionnaire(Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS)
- Muscle Strength(Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS)
- Six Minute Walk Test (6MWT) and Borg Dyspnea Rating(Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS)
- Dyspnea Scale(Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS)
- Medical Outcome Survey Short-Form-36 (SF-36) Questionnaire(Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS)
- Body Composition(Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS)
- Body Mass Index (BMI)(Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS)
- Cardiopulmonary Exercise Test(Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS)