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Active, Not Recruiting

NCT Number: NCT03740867

Does Cognitive Status Affect Pulmonary Rehabilitation Gains?

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cognitive Impairment Behavior Cognition Disorders Cognitive Dysfunction Mental Disorders Motor Activity Neurocognitive Disorders Pulmonary Rehabilitation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, 34200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulmonary Rehabilitation

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2018
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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