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临床试验/NCT04244305
NCT04244305Unknown不适用

Endurance Training in Patients Undergoing Lung Transplantation: Differences Between Treadmill and Cycle Ergometry Training

University Hospital A Coruña0 个研究点目标入组 80 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
主要终点
6 Minute Walk Test

研究概览

简要总结

Lung Transplantation is usually the last option for patients with chronic respiratory conditions in the late stages of the disease. Pulmonary rehabilitation and, particularly, endurance training, is a cornerstone in the management of these patients both during the pre-operative as well as the post-operative period as it improves cardiopulmonary fitness, muscle mass, muscle strength, health-related quality of life and potentially, survival. However, very few studies have been published addressing which modality of training, intensity, frequency or duration of training provides the best possible results in these patients. Therefore, the objective of this study was to compare two training modalities (treadmill walking versus cycle-ergometry) on functional capacity, muscle strength and lung function.

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)

盲法说明

Assessors were blinded to group allocation of the participants

入排标准

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

入选标准

  • Patients undergoing lung transplantation at the Thoracic Surgery Unit of the Hospital Clínico Universitario de A Coruña.
  • Adults > 18 years.
  • Ability to attend post-surgery exercise training for a minimum period of one month.
  • Sign informed consent.

排除标准

  • Torpid post-operative recovery with a prolonged stay at the Post-Anaesthesia Care Unit > 12 days.
  • Diagnosed with intensive care unit acquired muscle weakness.

结局指标

主要结局

6 Minute Walk Test

时间窗: 1 month

Distance covered during the 6 Minute Walk Test performed according to the American Thoracic Guidelines.

次要结局

  • Forced Expiratory Capacity (FVC)(1 and 3 months)
  • 6 Minute Walk Test(3 Months)
  • Sit-to-stand(1 and 3 months)
  • Incremental Symptom-Limited Test(1 and 3 months)
  • Maximal isometric strength(1 and 3 months)
  • Forced Expiratory Volume 1st second (FEV1)(1 and 3 months)
  • Maximal inspiratory and expiratory pressures(1 and 3 months)
  • Peak Expiratory Flow (PEF)(1 and 3 months)

研究者

发起方
University Hospital A Coruña
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esther Gimenez Moolhuyzen

Principal Investigator

University Hospital A Coruña

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