Effects of Combined Cognitive Rehabilitation in COPD Patients

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03907839
• Other study ID #: pulmonary rehabilitation
• Status: Completed
• Phase: N/A
• Start date: December 15, 2016
• Est. completion date: March 15, 2019

Study information

• Verified date: April 2019
• Source: Faculty of Medicine, Sousse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 15, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 60 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• clinical trials
examined two type of training on cognitive parameters for COPD patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Faculty of Medicine, Sousse

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2007 May 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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