NCT03907839

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
Last Updated

August 2, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

April 3, 2019

Last Update Submit

July 31, 2019

Conditions

Keywords

COPDcognitive trainingcognitive impairmentP300 testMOCA

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 COMPARATOR

endurance training for control group

Other: clinical trials

ET+cognitive training(CT)

EXPERIMENTAL

endurance training added to cognitive training for exprimental COPD group

Other: clinical trials

Interventions

examined two type of training on cognitive parameters for COPD patients

ET+cognitive training(CT)Endurance Training (ET)

Eligibility Criteria

Age60 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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: 24738069BACKGROUND
  • 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.

    PMID: 23349026BACKGROUND
  • 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.

    PMID: 26640377BACKGROUND
  • 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.

    PMID: 17532116BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCognitive Dysfunction

Interventions

Clinical Trials as Topic

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Clinical Studies as TopicEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

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