- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03528447
The Effect of Pulmonary Rehabilitation on Cognitive Status in Lung Transplantation Candidates
Study Overview
Status
Conditions
Intervention / Treatment
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 pulmonary rehabilitation on cognitive status in candidate lung transplant recipients.
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 concil 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Zeytinburnu
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Istanbul, Zeytinburnu, Turkey, 34200
- Yedikule Chest Disease Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pulmonary Rehabilitation
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline distance covered in six minute walking test at 3-months.
Time Frame: 6 minute
|
6 minute
|
|
|
Change from baseline The Montreal Cognitive Assessment (MoCA) at 3-months
Time Frame: 15 minute
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline modified Medical Council Dyspnea score at 3-months
Time Frame: 5 minute
|
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.
|
5 minute
|
|
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 3-months
Time Frame: 20 minute
|
20 minute
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR_cognition
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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