The Effect of Pulmonary Rehabilitation on Cognitive Status in Lung Transplantation Candidates

NCT03528447 | Active Not Recruiting

• 1 other identifier: PR_cognition
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary rehabilitation program with aerobic and strengthening 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. Cognitive functions and exercise capacities of the patients before and after the program will be evaluated.

Conditions

Cognitive Impairment; Pulmonary Rehabilitation

Keywords

lung transplantation; cognition; MOCA; exercise; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change from baseline distance covered in six minute walking test at 3-months.

  6 minute

• Change from baseline The Montreal Cognitive Assessment (MoCA) at 3-months

  The Montreal Cognitive Assessment (MoCA; Nasreddine et al., 2005) takes approximately 10 minutes to administer and 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) (Nasreddine et al., 2005). The MoCA is scored by obtaining an item total and the authors recommend a clinical cutoff score of 26.

  15 minute

Secondary Outcomes (2)

• Change from baseline modified Medical Council Dyspnea score at 3-months

  5 minute

• Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 3-months

  20 minute

Study Arms (1)

Pulmonary Rehabilitation

EXPERIMENTAL

Lung transplantation candidates who refered from Lung Transplantation surgery team will undergo the Pulmonary Rehabilitation program for 3-months (2 days at hospital, 3 days at home). Patient will evaluate at the beginning and end of the program.Cognitive functions and exercise capacities of the patients before and after the program will be evaluated.

Other: Pulmonary Rehabilitation

Interventions

Pulmonary Rehabilitation OTHER

Aerobic training:The aerobic exercise program consists of treadmill walking, cycle ergometer and arm ergometer training. Group exercises were performed in sets of 15 minutes each with three exercise modalities. Strength training:It is recommended that resistance targets are set at loads equivalent to 20 to 40% of a 1-repetition maximum (1RM) maneuver and performed between 8 to 12 repetitions for 1 to 2 sets per session. Home exercise programme:The program included breathing exercises (local expansion exercises, diaphragmatic breathing and pursed lip breathing), free walking, upper and lower extremity strengthening exercises with Thera-Band.

Pulmonary Rehabilitation

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 17, 2018
• Study Start: May 20, 2018
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

TU (1)