Does Cognitive Status Affect Pulmonary Rehabilitation Gains?

NCT03740867 | Active Not Recruiting

• 1 other identifier: Cognition_PR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Pulmonary Rehabilitation

Keywords

Cognitive Impairment; pulmonary rehabilitation; exercise; MOCA; aerobic training

Outcome Measures

Primary Outcomes (2)

• Change from Baseline the 6 minutes walk distance at 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.

  3 months

• Change from Baseline the Montreal Cognitive Assessment (MoCA) test score at 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.

  3 months

Secondary Outcomes (2)

• Change from Baseline the modified Medical Council Dyspnea score at 3 months.

  3 months

• Change from Baseline the Forced Expiratory Volume in 1 second (FEV1) at 3 months.

  3 months

Study Arms (2)

Group1

EXPERIMENTAL

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

Group2

EXPERIMENTAL

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

Interventions

Pulmonary rehabilitation OTHER

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

Group1; Group2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, 34200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Esra Pehlivan, PhD

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 14, 2018
• Study Start: November 13, 2018
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

TU (1)