Clinical trial NCT03740867: Does Cognitive Status Affect Pulmonary Rehabilitation Gains?
Official title: Does Cognitive Status Affect Pulmonary Rehabilitation Gains?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Pulmonary Rehabilitation
Keywords: Cognitive Impairment
pulmonary rehabilitation
exercise
MOCA
aerobic training
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change from Baseline the 6 minutes walk distance at 3 months.
timeFrame: 3 months
measure: Change from Baseline the Montreal Cognitive Assessment (MoCA) test score at 3 months.
timeFrame: 3 months
Secondary outcomes:
measure: Change from Baseline the modified Medical Council Dyspnea score at 3 months.
timeFrame: 3 months
measure: Change from Baseline the Forced Expiratory Volume in 1 second (FEV1) at 3 months.
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yedikule Chest Disease Hospital
state: Zeytinburnu
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Esra Pehlivan, PhD
role: PRINCIPAL_INVESTIGATOR
References: