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临床试验/NCT03907839
NCT03907839已完成不适用

Effects of Cognitive Training Combined With Pulmonary Rehabilitation on Exercise Tolerance and Cognitive Functions in COPD Patients: a Randomized Controlled Trial

Faculty of Medicine, Sousse0 个研究点目标入组 60 人开始时间: 2016年12月15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
60
主要终点
6 minute walk test

研究概览

简要总结

This study was to examine the effect of endurance training combined with cognitive training in patients with COPD. The intervention group underwent Cognitive Training added to Endurance Training and the control group underwent only Endurance Training.

详细描述

Pulmonary rehabilitation is an essential part of the management of COPD. Although various methods and therapies of PR have been used in COPD patients. Furthermore, the Cognitive Training has been performed people with mild cognitive impairments.

Therefore, the combination of endurance training and cognitive tarining could be another alternative to improve the exercise tolerance and cognitive function in patients with COPD. It may also be useful for clinicians interested in designing new rehabilitation therapies. The aim of the study was to analyze the effect of CT combined with ET on exercise tolerance and cognitive functions in COPD patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
60 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • clinically stable COPD diagnosed by pulmonary function testing (2) absence of heart diseases, severe psychiatric, neurologic or musculoskeletal conditions and /or instable cardiovascular diseases. (3) Absence of medication influencing cognition (4) without history of brain injury, history of stroke or history of alcoholism.

排除标准

  • smoking COPD
  • heart diseases
  • instable cardiovascular diseases

研究组 & 干预措施

Endurance Training (ET)

Active Comparator

endurance training for control group

干预措施: clinical trials (Other)

ET+cognitive training(CT)

Experimental

endurance training added to cognitive training for exprimental COPD group

干预措施: clinical trials (Other)

结局指标

主要结局

6 minute walk test

时间窗: 1 day

The patients are instructed to cover the maximal distance in 6 min.Dyspnea was measured using Borg scale before the start of 6MWT and at the end of the test. Portable Spiropalm COSMED recorded heart rate (HR) and oxygen saturation (SpO2) continuously throughout the 6MWT. At the end of the 6MWT, the total covered distance was recorded.

Montreal cognitive assessment test

时间窗: 1 day

The test, scored on a scale of 0-30 points, is designed to identify cognitive impairment by assessing multiple cognitive domains. MOCA scores between 26 and 30 are consid¬ered normal, while scores \< 26 indicate cognitive impairment

P300 test

时间窗: 2 days

The electroencephalogram signals were recorded with Fz, Cz, and Pz, electrodes. The P3b and P3a components were identified as the largest positive deflections between 250 ms and 500 ms, respectively, in the target and novel responses. Scalp electrode activity was measured at all electrode sites of which Fz, Cz, and Pz were analyzed. Fz, Cz, and Pz were chosen for analyses because ERPs responses are largest on the midline locations.

次要结局

未报告次要终点

研究者

发起方
Faculty of Medicine, Sousse
申办方类型
Other
责任方
Principal Investigator
主要研究者

Imen Sanaa

PhD

Faculty of Medicine, Sousse

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