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临床试验/NCT03531138
NCT03531138已完成不适用

Is it Possible to Use the Timed Performance Tests in Lung Transplantation Candidates to Determine the Exercise Capacity?

Istanbul Medipol University Hospital1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2018年5月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
1
主要终点
Change from baseline 5 times sit to stand test at 3-months

研究概览

简要总结

Lung transplantation candidates will be performed a 3-month hospital-based preoperative exercise training. A 6-minute walk test, a 10-meter walking speed test and a 5-times sit to stand test will be performed to determine the exercise capacity of the patient. The tests will be carried out at the beginning and end of rehabilitation. At each testing session, the tests will be performed sequentially by the same physiotherapist, giving 20 minute rest periods within the same day. It will be analyzed how the test data correlate with each other and how the delta values calculated for each test reflect the rehabilitation outcomes calculated after the exercise program.

详细描述

Severe exercise intolerance exists in lung transplant candidates. Completion of the test period in the field tests used in determining the exercise capacity of these patients is extremely difficult. The exercise capacity, which is considered as an important criterion in the decision of the lung transplant decision and in the determination of the clinical profile of the patient, necessitates the development of different test methods which are more suitable for the application of the measurement in this patient population.

In this study lung transplantation candidates will be performed a 3-month hospital-based preoperative exercise training. A 6-minute walk test, a 10-meter walking speed test and a 5-times sit to stand test will be performed to determine the exercise capacity of the patient. The tests will be carried out at the beginning and end of rehabilitation. At each testing session, the tests will be performed sequentially by the same physiotherapist, giving 20 minute rest periods within the same day. It will be analyzed how the test data correlate with each other and how the delta values calculated for each test reflect the rehabilitation outcomes calculated after the exercise program.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • •To be taken to the list for lung transplant
  • •Do not have any addiction that may interfere with exercise

排除标准

  • •Do not accept to study

研究组 & 干预措施

Pulmonary rehabilitation group

Experimental

All patients will undergo supervised pulmonary rehabilitation program on 2 days per week for 3 months. Apart from that, they will ask to perform the home exercise program which is scheduled as 3 days per week.

干预措施: Pulmonary Rehabilitation (Other)

结局指标

主要结局

Change from baseline 5 times sit to stand test at 3-months

时间窗: 3-months

Patient stand up and sit as quickly as possible from a standard chair for 5 times.Introduction: "Stand up and sit down as quickly as possible 5times, keeping your arms folded across your chest. I'll be timing you with a stopwatch. Ready, begin".The time is measured. Lower times = better scores.

Change from baseline distance covered in six minute walking test at 3-months

时间窗: 3-months

The test was conducted in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Patients were told that they should walk as fast as they can walk. Before and after the test, oxygen saturation, heart rate, Borg fatigue rating, and walking distance were recorded.

Change from baseline 10-meter walking speed test at 3-months

时间窗: 3-months

The patient walks without assistance 10 meters (32.8 feet) and the time is measured.

次要结局

  • Change from baseline Modified Medical Research Council (mMRC) Dyspnea Scale score at 3-months(3-months)
  • Change from baseline Maximum Inspiratory Pressure (MIP) at 3-months(3-months)
  • Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 3-months.(3-months)
  • Change from baseline quadriceps femoris muscle strength at 3-months.(3-months)

研究者

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

esra pehlivan

Principal investigator

Istanbul Medipol University Hospital

研究点 (1)

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