Chronic Effect of Whole-body Electrical Stimulation in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 主要终点
- Peripheral muscle strength
研究概览
简要总结
Randomized clinical trial. Patients with chronic obstructive pulmonary disease (COPD) GOLD III or IV will undergo 16 sessions of Whole-body Electrical Stimulation (WB-EMS) or pulmonary rehabilitation (PR), twice a week. WB-EMS will be performed in association with squats, biceps and triceps exercises, climbing up and down a step, and abdominal exercises. There will be a progression in the number of muscle contractions after the fourth (from 64 to 96) and tenth sessions (96 to 120). PR will consist of upper and lower limb strengthening exercises. Both groups will perform aerobic exercise (essential component of the pulmonary rehabilitation program). Peripheral muscle strength (dynamometry), respiratory muscle strength (maximum inspiratory and expiratory pressure), muscle thickness (ultrasound), functional capacity (6MWT), quality of life (Saint George's Respiratory Questionnaire), inflammatory profile (PCR, IL-6 e IL-10, TNFα), oxidative stress (protein oxidation, superoxide dismutase and catalase, total hydrogen sulfides, dichlorofluorescein diacetate) will be assessed before and after the 16 sessions.
详细描述
Patients with chronic obstructive pulmonary disease (COPD) will undergo a 16-session whole-body electrical stimulation (WB-EMS) protocol or a pulmonary rehabilitation program, twice a week, for eight weeks. The 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. Symmetrical pulsed biphasic current will be used, pulse width of 400 µs, frequency of 75 Hz. In the first two weeks, the contraction time will be five seconds and the rest time will be 10 seconds, the session will last 16 minutes, resulting in 64 muscle contractions. In weeks 3, 4 and 5, the contraction time will be five seconds and the rest time will be five seconds, the session will last 16 minutes, resulting in 96 muscle contractions. In weeks 6, 7 and 8, the contraction time will be five seconds and the rest time will be five seconds. The session will last 20 minutes, resulting in 120 muscle contractions. During the first two minutes of stimulation, the patient will remain in isometric position to familiarize themselves with the electrical current. After that, a series of squats, biceps and triceps exercises (using a proprioception stick), abdominal exercises and climbing up and down a step will be performed. At the end of each session, patients will do aerobic exercise (bicycle or treadmill). Pulmonary rehabilitation will consist of muscle strengthening exercises, using weights, ankle weights and weight training equipment. Squats, biceps and triceps exercises (with weights), knee flexion and extension (equipment with weights) and stretching will be performed. At the end of each session, patients will do aerobic exercise (bicycle or treadmill). Peripheral muscle strength (dynamometry), respiratory muscle strength (maximum inspiratory and expiratory pressure), muscle thickness (ultrasound), functional capacity (6MWT), quality of life (Saint George's Respiratory Questionnaire), inflammatory profile (PCR, IL-6 e IL-10, TNFα), oxidative stress (protein oxidation, superoxide dismutase and catalase, total hydrogen sulfides, dichlorofluorescein diacetate) will be assessed before and after the 16 sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 muscle strength
时间窗: Two months
Peripheral muscle strength will be assessed by maximum isometric strength of the knee extensor, elbow flexor and palmar flexor muscles using a hand-held dynamometer
次要结局
- Maximum inspiratory pressure(Two months)
- Maximum expiratory pressure(Two months)
- Muscle thickness(Two months)
- Functional capacity(Two months)
- Quality of life(Two months)
- Inflammatory profile(Two months)
- Oxidative stress(Two months)
研究者
Jociane Schardong
Principal Investigator
Federal University of Health Science of Porto Alegre