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临床试验/NCT04244734
NCT04244734Unknown不适用

Implementation of an Early Rehabilitation Program for the Patient With Lung Transplantation: From the ICU to Home.

Hospital Universitari Vall d'Hebron Research Institute2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2019年5月23日最近更新:
适应症

试验速览

阶段
不适用
入组人数
85
试验地点
2
主要终点
Muscle mass

研究概览

简要总结

Introduction: Following pulmonary transplantation (PT), peripheral and respiratory muscle weakness, and associated global malfunction are some of the limiting factors in rapid recovery. Effective early implantation pulmonary rehabilitation programs are currently lacking.

Objectives: To introduce an early rehabilitation program in the ICU after PT to see if there is an improvement in functionality, an increase in strength and muscle mass, an improvement in the strength of the respiratory muscles and a shorter hospitalization time in the ICU and in the ward.

Methodology: A single-blind randomized clinical trial will be performed to divide patients with PT into one experimental group and another control group. Prior to the PT, those patients between the ages of 18 and 70 will be recruited, to be admitted to the ICU of Vall Hebron University Hospital, and who have been prescribed pulmonary rehabilitation with onset in the first 15 days after the surgery. The control group receives regular treatment in the ICU, which includes muscle strengthening exercises, passive/assisted or active mobilizations, and respiratory physiotherapy with breathing muscle strengthening in a medium load. The experimental group receives a new early rehabilitation program based on a patient's in-bed cycling that allows controlled and adapted training to the patient's situation, along with coordinated exercise with neuromuscular electrostimulation and respiratory physiotherapy with breathing muscle strengthening in a high load. Improvement will be observed through functional scales (6MWT), muscle dynamometry, manual muscle test (MRC-SumScore), bioimpedanciometry, inspiratory and maximal expiratory pressures, spirometry, frailty and sarcopenia tests and a long-term Cardiopulmonary Exercise Testing.

Expected Outcomes: Patients who perform the experimental group are expected to have an early discharge from the ICU and a reduction of the total hospital admission. Is also expected that the experimental group will improve the functional capacity and muscular strength, and they will have a lower risk of fragility in long term. It is also expected that the patients in the experimental group will soon be able to normalize their oxygen consumption a year after 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 (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral or bilateral lung transplantation.
  • Age criteria (From 18 to 70 years old).
  • Start the rehabilitation program between the first 15 days after lung transplantation.

排除标准

  • Do not meet inclusion criteria.
  • Fulfill some criterion of absolute contraindication for the use of electrostimulation in the lower extremities (pacemaker, pregnancy or unstable fracture that requires absolute rest and immobilization.
  • Cognitive or psychiatric alteration that does not allow you to participate in the project.
  • Not wanting to participate in the study.

结局指标

主要结局

Muscle mass

时间窗: Through study completion, an average of 1 year

Measured with bioimpedanciometry It will be measured in different moments: Baseline Hospital discharge After 1 month of discharge After 4 month of discharge 1 year after the discharge

Respiratory muscle strength

时间窗: Through study completion, an average of 1 year

Measured with MIP and MEP It will be measured in different moments Baseline When patient awake in ICU (RASS -1/0) Hospital discharge After 1 month of discharge After 4 month of discharge 1 year after the discharge

Cough strength

时间窗: Through study completion, an average of 1 year

Measured with Peak Cough Flow It will be measured in different moments Baseline When patient awake in ICU (RASS -1/0) Hospital discharge After 1 month of discharge After 4 month of discharge 1 year after the discharge

Exercise Capacity

时间窗: Through study completion, an average of 1 year

Measured with 6MWT It will be measured in different moments: Baseline Hospital discharge After 1 month of discharge After 4 month of discharge 1 year after the discharge

Muscle strength

时间窗: Through study completion, an average of 1 year

Measured with dynamometer It will be measured in different moments Baseline When patient awake in ICU (RASS -1/0) Hospital discharge After 1 month of discharge After 4 month of discharge 1 year after the discharge

次要结局

  • Frailty(Through study completion, an average of 1 year)
  • Muscle balance(Through study completion, an average of 1 year)
  • Pulmonary Capacity(Through study completion, an average of 1 year)
  • Oxygen consumption(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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