Whole-Body Electrical Stimulation in Patients Undergoing Lung Transplantation: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Isometric quadriceps muscle strength.
研究概览
简要总结
This study aims to evaluate the effects of whole-body electrical stimulation (WB-EMS) in the rehabilitation of patients undergoing lung transplantation. This is a randomized clinical trial with patients from the inpatient unit of Dom Vicente Scherer Hospital of Irmandade Santa Casa de Misericórdia from Porto Alegre (ISCMPA) who will be allocated to a control group (which will receive physiotherapy from routine) or intervention group (which will receive physiotherapy from routine and WB-EMS). Interventions with WB-EMS will occur every day from the moment of extubation until hospital discharge (15 sessions per patient). Assessments will be carried out pre-lung transplantation, after extubation, during intervention protocols and at the time of hospital discharge.
详细描述
Patients on the lung transplant list may experience post-procedure complications that culminate in a higher risk of mortality, which are related to primary and chronic graft dysfunction and infections. These complications are partly responsible for prolonged immobility, sarcopenia, decline in functional capacity and deterioration in quality of life. There is evidence that physical rehabilitation, mainly through exercise, improves the physical capacity and quality of life of transplant patients. However, not all patients are able to perform this type of activity due to low tolerance for it. In this sense, WB-EMS can be an alternative for early rehabilitation. This study aims to evaluate the effects of WB-EMS in the rehabilitation of patients undergoing lung transplantation.
Patients will be selected from the Pulmonary Rehabilitation Center of Pereira Filho Hospital prior to lung transplantation and the following assessments will be carried out: muscle architecture and quality (ultrasound), peripheral muscle strength (dynamometry of lower and upper limbs, Medical Research Council scale and 10-repetition sit-and-stand test), respiratory muscle strength (manovacuometry) and functional capacity (six-minute walk test). After the transplant, with the patient admitted to the intensive care unit, and after being extubated, blood sample will be collected to measure muscle damage, also it will be evaluated the muscle architecture and quality, peripheral muscle strength (only using the Medical Research Council scale) and respiratory muscle strength. Prior to hospital discharge, muscle architecture and quality, peripheral muscle strength (dynamometry of lower and upper limbs, Medical Research Council scale and 10-repetition sit-and-stand test), respiratory muscle strength, functional capacity, and muscle damage will be reassessed, along with the length of hospital stay.
During the training period, the safety of the therapy will be assessed by monitoring cardiorespiratory parameters, muscle pain (analogic visual scale) and fatigue (Borg subjective perceived exertion scale).
Patients will be randomized to the control group (GC) (which will receive physiotherapy from routine) or the intervention group (GI), which will perform whole-body electrical stimulation using the equipment ReCARE® (Visuri, Minas Gerais, Brazil), in addition to routine physiotherapy. After extubation, patients will begin the protocol for 15 sessions and will be reevaluated, therefore the protocol begins in the intensive care unit and will be completed in the inpatient unit.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing unilateral or bilateral lung transplantation;
- •Admitted to the intensive care unit and without invasive ventilatory support;
- •Hemodynamically stable;
- •Time less than or equal to 7 days between lung transplantation and the beginning of rehabilitation protocols.
排除标准
- •Patients with severe psychomotor agitation;
- •Recent acute myocardial infarction (24 hours) and / or uncontrolled arrhythmias;
- •Temporary transcutaneous pacemaker;
- •Stroke after lung transplantation;
- •Decompensated heart failure;
- •Uncontrolled hypertension (systolic blood pressure > 230 mmHg and diastolic blood pressure > 120 mmHg) or mean arterial pressure <60 mmHg;
- •Patients who present important hemodynamic changes during training;
- •Peripheral vascular changes in the lower limbs such as untreated deep vein thrombosis;
- •In a feverish state;
- •Patients with epidermal lesions on the thighs that make it impossible to place self-adhesive electrodes for electrical stimulation;
- •Patients with acute renal failure.
结局指标
主要结局
Isometric quadriceps muscle strength.
时间窗: Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).
Isometric quadriceps muscle strength will be evaluated using a portable dynamometer.
Lower limb muscle strength.
时间窗: Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).
Lower limb strength will be carried out using the 10-repetition sit-and-stand test (SST).
Mortality.
时间窗: Mortality will be assessed after 30 days, after 60 days and up to 1 year after lung transplantation.
Mortality will be assessed by counting the number of deaths occurring in the study and after hospital discharge.
次要结局
- Respiratory muscle strength.(Time 0 (baseline), on the first day after extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).)
- Functional capacity.(Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).)
- Length of hospital stay.(From randomization to discharge or death from any cause, whichever comes first, assessed up to 3 months.)
- Overall muscle strength.(Time 0 (baseline), on the first day after extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).)
- Isometric muscle strength of the elbow flexors.(Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).)
- Muscle pain.(Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.)
- Upper limb muscle strength.(Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).)
- Muscle architecture.(Time 0 (baseline), on the first day after extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).)
- Safety of whole-body electrical stimulation.(Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.)
- Muscle damage.(On the first day post extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).)
研究者
Jociane Schardong
Principal Investigator
Federal University of Health Science of Porto Alegre