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
1 other identifier
interventional
60
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2019
CompletedFirst Submitted
Initial submission to the registry
April 3, 2019
CompletedFirst Posted
Study publicly available on registry
April 9, 2019
CompletedAugust 2, 2019
April 1, 2019
2 years
April 3, 2019
July 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Endurance Training (ET)
ACTIVE COMPARATORendurance training for control group
ET+cognitive training(CT)
EXPERIMENTALendurance training added to cognitive training for exprimental COPD group
Interventions
examined two type of training on cognitive parameters for COPD patients
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- smoking COPD
- heart diseases
- instable cardiovascular diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
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.
PMID: 24738069BACKGROUNDDodd 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.
PMID: 23349026BACKGROUNDBersani 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.
PMID: 26640377BACKGROUNDKirkil 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.
PMID: 17532116BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
April 3, 2019
First Posted
April 9, 2019
Study Start
December 15, 2016
Primary Completion
December 15, 2018
Study Completion
March 15, 2019
Last Updated
August 2, 2019
Record last verified: 2019-04