Effects of Combined Cognitive Rehabilitation in COPD Patients

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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: clinical trials

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• smoking COPD
• heart diseases
• instable cardiovascular diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Endurance Training (ET); endurance training for control group	Other: clinical trials; examined two type of training on cognitive parameters for COPD patients
Experimental: ET+cognitive training(CT); endurance training added to cognitive training for exprimental COPD group	Other: clinical trials; examined two type of training on cognitive parameters for COPD patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minute walk test	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.	1 day
Montreal cognitive assessment test	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	1 day
P300 test	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.	2 days

Collaborators and Investigators

• Sponsor: Faculty of Medicine, Sousse

Publications and helpful links

General Publications

• Cleutjens FA, Janssen DJ, Ponds RW, Dijkstra JB, Wouters EF. COgnitive-pulmonary disease. Biomed Res Int. 2014;2014:697825. doi: 10.1155/2014/697825. Epub 2014 Mar 16.
• Dodd JW, Charlton RA, van den Broek MD, Jones PW. Cognitive dysfunction in patients hospitalized with acute exacerbation of COPD. Chest. 2013 Jul;144(1):119-127. doi: 10.1378/chest.12-2099.
• Bersani FS, Minichino A, Fattapposta F, Bernabei L, Spagnoli F, Mannarelli D, Francesconi M, Pauletti C, Corrado A, Vergnani L, Taddei I, Biondi M, Delle Chiaie R. Prefrontocerebellar transcranial direct current stimulation increases amplitude and decreases latency of P3b component in patients with euthymic bipolar disorder. Neuropsychiatr Dis Treat. 2015 Nov 19;11:2913-7. doi: 10.2147/NDT.S91625. eCollection 2015.
• Kirkil G, Tug T, Ozel E, Bulut S, Tekatas A, Muz MH. The evaluation of cognitive functions with P300 test for chronic obstructive pulmonary disease patients in attack and stable period. Clin Neurol Neurosurg. 2007 Sep;109(7):553-60. doi: 10.1016/j.clineuro.2007.03.013. Epub 2007 May 29.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2016
• Primary Completion (Actual): December 15, 2018
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2019
• Last Update Submitted That Met QC Criteria: July 31, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: COPD; cognitive training; cognitive impairment; P300 test; MOCA
• Other Study ID Numbers: pulmonary rehabilitation (Home-based pulmonary rehabilitation in COPD)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No