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临床试验/NCT03528447
NCT03528447进行中(未招募)不适用

The Effect of Pulmonary Rehabilitation on Cognitive Status in Lung Transplantation Candidates

Istanbul Medipol University Hospital2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2018年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
59
试验地点
2
主要终点
Change from baseline distance covered in six minute walking test at 3-months.

研究概览

简要总结

Pulmonary rehabilitation program with aerobic and strengthening for 3 months will be applied to the candidates for lung transplantation. The program will be designed to be 2 days supervised weekly and 3 day home program. Cognitive functions and exercise capacities of the patients before and after the program will be evaluated.

详细描述

The fact that cognition is not always included in the assessment routine makes it difficult to clarify which patient group or severity of illness is more affected by this issue. The effect of exercise on cognitive functions is a remarkable issue in recent years. It can also be predicted that cognitive function may be effective on program adaptation in patients who are given home program without supervision. The aim of the investigator's study was to investigate the effect of pulmonary rehabilitation on cognitive status in candidate lung transplant recipients.

Lung transplantation candidates who refered from Lung Transplantation surgery team will receive the Pulmonary Rehabilitation program for 3-months (2 days at hospital, 3 days at home). Exercise program includes aerobic (walking band, bicycle, arm ergometer) and strengthening (with free weights) components. Patient will evaluate at the beginning and end of the program. Demographic information, diagnosis distributions, educational status of patients will be recorded. Exercise capacities are determined by 6 min walk test. The medical research concil dyspnea scale is used in determining the dispense levels. Montreal Cognitive Function Assessment (MOCA) is used to determine cognitive functions. Cognitive functions and exercise capacities of the patients before and after the program will be evaluated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • To be listed for lung transplantation,
  • Pulmonary rehabilitation exercise program planned to be taken,
  • Volunteers who have agreed to participate in the work,
  • Patients who can complete the 3-month Pulmonary Rehabilitation program.

排除标准

  • Failure to complete the planned exercise program for any reason,
  • Not to be literate.

结局指标

主要结局

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

时间窗: 6 minute

Change from baseline The Montreal Cognitive Assessment (MoCA) at 3-months

时间窗: 15 minute

The Montreal Cognitive Assessment (MoCA; Nasreddine et al., 2005) takes approximately 10 minutes to administer and was designed to detect mild cognitive impairment.Thirty items assessing multiple cognitive domains are contained in the MoCA: short-term memory (5 points); visuospatial abilities via clock drawing (3 points), and a cube copy task (1 point); executive functioning via an adaptation of Trail Making Test Part B (1 point), phonemic fluency (1 point), and verbal abstraction (2 points); attention, concentration, and working memory via target detection (1 point), serial subtraction (3 points), digits forward (1 point), and digits backward (1 point); language via confrontation naming with low-familiarity animals (3 points), and repetition of complex sentences (2 points); and orientation to time and place (6 points) (Nasreddine et al., 2005). The MoCA is scored by obtaining an item total and the authors recommend a clinical cutoff score of 26.

次要结局

  • Change from baseline modified Medical Council Dyspnea score at 3-months(5 minute)
  • Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 3-months(20 minute)

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 (2)

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