Acute Effect of Whole-body Electrical Stimulation in COPD Patients: a Crossover Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Peripheral oxygen saturation
研究概览
简要总结
Patients with chronic respiratory diseases present in addition to respiratory symptoms, peripheral muscle dysfunction, which contributes to functional impairment. The aim of the study is to investigate the safety of whole-body electrical stimulation in patients with chronic obstructive pulmonary disease (COPD). Patients will perform two whole body electrostimulation protocols, with an interval of one week between them. The primary outcome will be the safety of electrical stimulation through peripheral oxygen saturation, respiratory rate, systolic blood pressure, diastolic blood pressure, heart rate, dyspnea and fatigue (Borg subjective perceived exertion scale), autonomic control (rate variability cardiac arrest) and occurrence of adverse events. Secondary outcomes will be muscle damage assessed by serum creatine kinase level, muscle fatigue assessed by serum lactate level, delayed onset muscle soreness assessed by visual numerical scale, and peripheral muscle strength by dynamometry.
详细描述
Patients with COPD will be submitted to two whole body electrostimulation protocols, with an interval of one week between them. Miha Bodytec equipment will be properly calibrated, with electrodes on the quadriceps, hamstrings, glutes, biceps, triceps, pectorals, abdomen, trapezius, latissimus dorsi and quadratus lumborum muscles. Symmetric pulsed biphasic current will be used, pulse width of 400µs, frequency of 75Hz, contraction time of five seconds, rest time of 10 seconds. Protocol 1 will take eight minutes resulting in 32 muscle contractions, and protocol 2 will take 16 minutes resulting in 64 muscle contractions. Initially, patients will undergo an assessment of autonomic control. Then, blood collection will be performed, the serum lactate level will be checked and muscle strength will be measured. Verification of systolic blood pressure, diastolic blood pressure, peripheral oxygen saturation, heart rate, respiratory rate and perception of dyspnea and fatigue (BORG) will occur immediately before and after the whole body electrical stimulation session. During the protocol, peripheral oxygen saturation, heart rate, respiratory rate and BORG will be checked. After the session, the serum lactate level will be checked, a new blood collection will be performed and autonomic control and muscle strength will be reassessed. After 24, 48 and 72 hours, new blood samples will be collected and muscle pain will be measured.
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
- None
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 COPD GOLD 3 and 4;
- •Age between 18 and 80 years;
- •Ability to ambulate.
排除标准
- •Cognitive dysfunction that prevents assessments from being carried out, as well as inability to understand and sign the informed consent form (ICF);
- •Intolerance to the electrostimulator and/or change in skin sensitivity;
- •Patients with stroke sequelae;
- •Recent acute myocardial infarction (two months);
- •Uncontrolled hypertension;
- •New York Heart Association grade IV heart failure or decompensated;
- •Unstable angina or arrhythmia;
- •Peripheral vascular changes in lower limbs such as deep vein thrombosis;
- •Disabling osteoarticular or musculoskeletal disease;
- •Uncontrolled diabetes (glycemia > 300mg/dL);
- •Patients with cancer and/or undergoing cancer treatment;
- •Patients with systemic lupus erythematosus or other autoimmune disease;
- •Artificial cardiac pacemaker;
- •Epilepsy;
- •Hemophilia;
- •Liver and kidney diseases.
结局指标
主要结局
Peripheral oxygen saturation
时间窗: Immediately after the session
Peripheral oxygen saturation will be assessed by pulse oximetry
Heart rate
时间窗: Immediately after the session
Heart rate will be assessed by pulse oximetry
Dyspnea and Fatigue
时间窗: Immediately after the session
Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale
Respiratory rate
时间窗: Immediately after the session
Respiratory rate will be assessed by respiratory rate count for one minute
Systolic blood pressure
时间窗: Immediately after the session
Systolic blood pressure will be assessed through sphygmomanometer
Diastolic blood pressure
时间窗: Immediately after the session
Diastolic blood pressure will be assessed through sphygmomanometer
Autonomic control
时间窗: Up to 10 minutes after the session
Autonomic control will be assessed through variability heart rate
Adverse events
时间窗: 72 hours after the session
Occurrence of adverse events will be assessed through patient report
次要结局
- Muscle damage(72 hours after the session)
- Delayed onset muscle pain(72 hours after the session)
- Peripheral muscle strength(Up to 40 minutes after the session)
- Muscle fatigue(6 minutes after the session)
研究者
Jociane Schardong
Principal Investigator
Federal University of Health Science of Porto Alegre