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Clinical Trials/NCT03740867
NCT03740867
Active, not recruiting
Not Applicable

Does Cognitive Status Affect Pulmonary Rehabilitation Gains?

Istanbul Medipol University Hospital1 site in 1 country50 target enrollmentNovember 13, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Impairment
Sponsor
Istanbul Medipol University Hospital
Enrollment
50
Locations
1
Primary Endpoint
Change from Baseline the 6 minutes walk distance at 3 months.
Status
Active, not recruiting
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 13, 2018
End Date
December 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul Medipol University Hospital
Responsible Party
Principal Investigator
Principal Investigator

esra pehlivan

Principal investigator

Istanbul Medipol University Hospital

Eligibility 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.

Outcomes

Primary Outcomes

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.

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 Outcomes

  • Change from Baseline the Forced Expiratory Volume in 1 second (FEV1) at 3 months.(3 months)
  • Change from Baseline the modified Medical Council Dyspnea score at 3 months.(3 months)

Study Sites (1)

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