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Does Cognitive Status Affect Pulmonary Rehabilitation Gains?

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ClinicalTrials.gov Identifier: NCT03740867
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
esra pehlivan, Istanbul Medipol University Hospital

Brief Summary:
Pulmonary rehabilitation program with aerobic and strengthening trainings for 3 months will be applied to the candidates for lung transplantation. The program will be designed to be 2 days supervised weekly and 3 day home program. After completion of the program, patients will be divided into two groups according to their cognitive status (Group 1: those with poor cognition; Group 2: those with good cognition). The PR gains of the groups will be compared.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Pulmonary Rehabilitation Other: Pulmonary rehabilitation Not Applicable

Detailed Description:

The fact that cognition is not always included in the assessment routine makes it difficult to clarify which patient group or severity of illness is more affected by this issue. The effect of exercise on cognitive functions is a remarkable issue in recent years. It can also be predicted that cognitive function may be effective on program adaptation in patients who are given home program without supervision. The aim of the investigator's study was to investigate the effect of cognitive status to pulmonary rehabilitation gains in lung transplant candidates.

Lung transplantation candidates who refered from Lung Transplantation surgery team will receive the Pulmonary Rehabilitation program for 3-months (2 days at hospital, 3 days at home). Exercise program includes aerobic (walking band, bicycle, arm ergometer) and strengthening (with free weights) components. Patient will evaluate at the beginning and end of the program. Demographic information, diagnosis distributions, educational status of patients will be recorded. Exercise capacities are determined by 6 min walk test. The medical research council dyspnea scale is used in determining the dispense levels. Montreal Cognitive Function Assessment (MOCA) is used to determine cognitive functions. Cognitive functions and exercise capacities of the patients before and after the program will be evaluated.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After completion of the program, patients will be divided into two groups according to their cognitive status (Group 1: those with poor cognition; Group 2: those with good cognition). The PR gains of the groups will be compared.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Does Cognitive Status Affect Pulmonary Rehabilitation Gains?
Actual Study Start Date : November 13, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Group1

Those with poor cognition (MOCA score<23)

The patients will receive the Pulmonary Rehabilitation program for 3-months (2 days at hospital, 3 days at home). Exercise program includes aerobic (walking band, bicycle, arm ergometer) and strengthening (with free weights) components.

Other: Pulmonary rehabilitation
Exercise program includes aerobic (walking band, bicycle, arm ergometer) and strengthening (with free weights) components.

Experimental: Group2

Those with good cognition (MOCA score≥23)

The patients will receive the Pulmonary Rehabilitation program for 3-months (2 days at hospital, 3 days at home). Exercise program includes aerobic (walking band, bicycle, arm ergometer) and strengthening (with free weights) components.

Other: Pulmonary rehabilitation
Exercise program includes aerobic (walking band, bicycle, arm ergometer) and strengthening (with free weights) components.




Primary Outcome Measures :
  1. Change from Baseline the 6 minutes walk distance at 3 months. [ Time Frame: 3 months ]
    The test was conducted in a 30-m corridor in line with American Thoracic Society (ATS) guidelines. Patients were told that they should walk as fast as they can walk in 6 minutes time.

  2. Change from Baseline the Montreal Cognitive Assessment (MoCA) test score at 3 months. [ Time Frame: 3 months ]
    It was designed to detect mild cognitive impairment.Thirty items assessing multiple cognitive domains are contained in the MoCA: short-term memory (5 points); visuospatial abilities via clock drawing (3 points), and a cube copy task (1 point); executive functioning via an adaptation of Trail Making Test Part B (1 point), phonemic fluency (1 point), and verbal abstraction (2 points); attention, concentration, and working memory via target detection (1 point), serial subtraction (3 points), digits forward (1 point), and digits backward (1 point); language via confrontation naming with low-familiarity animals (3 points), and repetition of complex sentences (2 points); and orientation to time and place (6 points). The MoCA is scored by obtaining an item total and the authors recommend a clinical cutoff score of 23.


Secondary Outcome Measures :
  1. Change from Baseline the modified Medical Council Dyspnea score at 3 months. [ Time Frame: 3 months ]
    The scale will rate the sensation of dyspnea as the person perceives it.The severity of dyspnea is rated on a scale of 0 to 4."0 point" means no dyspnea perception and "4point" means severe dyspnea perception.

  2. Change from Baseline the Forced Expiratory Volume in 1 second (FEV1) at 3 months. [ Time Frame: 3 months ]
    It was conducted using the Sensor Medics model 2400 (Yorba Linda, CA,USA), according to the ATS guidelines.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To be listed for lung transplantation,
  • Pulmonary rehabilitation exercise program planned to be taken,
  • Volunteers who have agreed to participate in the work,
  • Patients who can complete the 3-month Pulmonary Rehabilitation program.

Exclusion Criteria:

  • Failure to complete the planned exercise program for any reason,
  • Not to be literate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740867


Contacts
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Contact: Esra Pehlivan, PhD +905058527913 fztesrakambur@yahoo.com
Contact: Arif Balcı +90 212 4090200 ext 2485 arifbalci2000@yahoo.com

Locations
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Turkey
Yedikule Chest Disease Hospital Recruiting
Istanbul, Zeytinburnu, Turkey, 34200
Contact: Esra Pehlivan    +902124090200    fztesrakambur@yahoo.com   
Sponsors and Collaborators
Istanbul Medipol University Hospital
Investigators
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Principal Investigator: Esra Pehlivan, PhD University of Health Sciences

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Responsible Party: esra pehlivan, Principal investigator, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier: NCT03740867     History of Changes
Other Study ID Numbers: Cognition_PR
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by esra pehlivan, Istanbul Medipol University Hospital:
Cognitive Impairment
pulmonary rehabilitation
exercise
MOCA
aerobic training

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders