Efficacy of Early Inspiratory Muscle Training Combined With the Conventional Rehabilitation Programme in Lung Transplanted Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change in functional capacity: 6 minutes walk test (6MWT) measured in meters
研究概览
简要总结
Lung transplantation is an effective therapeutic option in the end-stage of chronic respiratory diseases. Lung transplantation improves lung function in terms of capacity and volume. However, the transplanted patient still suffers from muscle weakness and exercise intolerance.
In recent years, respiratory physiotherapy work has intensified in critically ill patients with respiratory muscle weakness and the application of inspiratory muscle training (IMT), which has been shown in several studies to increase inspiratory muscle strength (IMT), improve ventilation and reduce the sensation of shortness of breath. Despite this emerging evidence, inspiratory muscle training (IMT) is not standard practice in most ICUs around the world, nor is it included in a protocolised manner among the components of a pulmonary rehabilitation programme.
Given the limited evidence, the investigators propose to conduct this randomised controlled clinical trial in lung transplant recipients.
The study will compare two groups of transplanted patients, a control group that will follow the rehabilitation programme and standard medical care and another experimental group that will also perform inspiratory muscle training.
This study aims to analyse the effect of IMT on inspiratory muscle strength, exercise capacity and quality of life in lung transplant patients.
详细描述
For many years, lung transplantation has become an effective therapeutic option for end-stage chronic lung diseases. With transplantation, an improvement in lung function is achieved, achieving volumes and capacities close to those predicted.
After transplantation, muscle deterioration and exercise intolerance are still present; and it will take, according to studies, between 6 months to 1 year to achieve recovery to near normal values. Even in some cases, such as patients with a longer stay in the critical care unit who present a greater deterioration, these values do not reach normal values. In lung transplant recipients, pulmonary rehabilitation including aerobic exercise, resistance exercise and respiratory physiotherapy is the most effective strategy to improve exercise capacity and muscle strength.
Some clinical trials on inspiratory muscle training have identified favourable effects on respiratory muscle fitness and strength.
The purpose of this study is to analyse the impact of early training in lung transplant patients on respiratory muscle strength, exercise tolerance and quality of life. To this end, a randomised controlled trial will be carried out including lung transplant patients (single or double lung adults over 18 years of age) admitted to the hospital where a control group will perform the standard rehabilitation programme: respiratory, aerobic and upper and lower limb strength exercises; while the experimental group will be given inspiratory muscle training with a load of at least 30% of the maximum inspiratory pressure (MIP) in an early manner. Both groups will start the treatment in the critical care unit under conditions of clinical stability (haemodynamic, respiratory and neurologic) and will continue it in hospitalisation. Treatment is performed once a day, 5 days a week from Monday to Friday supervised by a trained physiotherapist.
Every 15 days a data collection will be performed to monitor the follow-up and the data collection will end 3 months after the lung transplantation.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Neither the professionals in charge of measuring the pre- and post-intervention outcomes nor the statistician are aware of the assignment.
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
- •Alert or able to cooperate with treatment.
- •Able to give Informed Consent and sign it.
- •Haemodynamically stable clinical situation or requiring minimal ventilatory support.
排除标准
- •Detection of complete paralysis of the diaphragm.
- •Progressive neuromuscular diseases or with spinal cord injury.
- •Lack of collaboration or cooperation, or non-alertness (Glasgow ≤8).
- •Unstable clinical situation (patients requiring high levels of ventilatory support (e.g., Positive End Expiratory Pressure (PEEP)> 10 cmH2O, Fraction Pressure of Inspired Oxygen (FiO2)> 0.60, nitric oxide, nebulised prostacyclin, high frequency oscillation).
- •Clinical situation compromising the patient's recovery (cardiac arrhythmias, acute sepsis).
- •When the medical treatment team and/or physiotherapy consider that there may be risks.
- •Severe pain or dyspnoea that interferes with or impedes the ability to breathe (e.g. rib fracture).
- •Patients with lung retransplantation.
- •Heart and lung transplant patients.
- •When the patient is on palliative treatment
结局指标
主要结局
Change in functional capacity: 6 minutes walk test (6MWT) measured in meters
时间窗: The groups will be assessed Pre-LT and 3 months after LT
6MWT is a submaximal exercise test that entails measurement of distance walked during 6 minutes. The 6MWT provides information regarding functional capacity, response to therapy and prognosis. The test will be in line with American Thoracic Society (ATS) guidelines Statement Guidelines for the Six Minutes Walk Test. Am J respi Crit Care Med 2002;166(1):111-117
Change in respiratory strength: maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measured in water centimeters (cmH2O).
时间窗: The groups will be assessed at six times:Pre -Lung transplantation (Pre-LT), at baseline, every 15 days and 3 months after LT
Maximum respiratory pressure will be measure using a Respiratory Pressure Meter (RPM) named Micro-RPM® . Ever since Black and Hyatt (1969) reported this technique, it is used in healthy control subjects across all ages and athletes. Pressure is recorded at the mouth during quasi-static short (few seconds) maximal breathing according to American Thoracic Society (ATS) guidelines.The maximum value will be obtained. Am J respi Crit Care Med 2002;166:531-535.
Change in Quality of life related with Health(SF-36) measured with a score from 0 to100
时间窗: The groups will be assessed Pre-LT and 3 months after LT
The SF-36 consists of 36 topics that explore eight dimensions of health status: physical function, physical role, bodily pain, general health, vitality, social function, emotional role, and mental health.The SF-36 was previously validated in chronic obstructive pulmonary disease (COPD) patients and has been used in patients before and after lung transplantation (LT). Respiration 2000;67:159-65. Chest 2000;118:408-16.
Change in Respiratory mechanics parameters: respiratory work measured in Joules (J)
时间窗: The groups will be assessed at baseline, every 15 days and 3 months after LT
Respiratory mechanics parameters will be analyzed using a POWERbreathe electronic device: the work of breathing is the area for total external inspiratory work as integrated from mouth pressure (cmH2O) and volume (L) signals over time. Physical Therapy 2015;95(9):1264-1273
Change in Inspiratory muscle endurance (Tlim) measure in seconds (s)
时间窗: The groups will be assessed at baseline, every 15 days and 3 months after LT
Inspiratory muscle endurance is the time the patient breathe against a submaximal inspiratory load provided by device (POWERbreathe) until task failure due to the symptom limitation. Physical Therapy 2015;95(9):1264-1273.
次要结局
- Incidence of atelectasis measured with a score from 0 to 4(The patients will be assessed through study completion, an average of 3 months)
- Change in Pulmonary Function measured with Spirometry Test. FEV1/FVC measured in %(The groups will be assessed Pre-LT, at baseline and 3 months after LT)
- Changes in dyspnea measured with the modified borg scale 0-10(The groups will be assessed at baseline, every 15 days and 3 months after LT)
研究者
Laura Muelas Gomez
Clinical physiotherapist
Puerta de Hierro University Hospital