Does Cognitive Status Affect Pulmonary Rehabilitation Gains?

Cognitive Impairment Clinical Trial

Official title:

Does Cognitive Status Affect Pulmonary Rehabilitation Gains?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03740867
• Other study ID #: Cognition_PR
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 13, 2018
• Est. completion date: December 1, 2025

Study information

• Verified date: January 2024
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Pulmonary Rehabilitation

Intervention

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

Locations

Country	Name	City	State
Turkey	Yedikule Chest Disease Hospital	Istanbul	Zeytinburnu

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change from Baseline the modified Medical Council Dyspnea score at 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.	3 months
Secondary	Change from Baseline the Forced Expiratory Volume in 1 second (FEV1) at 3 months.	It was conducted using the Sensor Medics model 2400 (Yorba Linda, CA,USA), according to the ATS guidelines.	3 months