The Effect of Pulmonary Rehabilitation on Cognitive Status in Lung Transplantation Candidates
Primary Purpose
Cognitive Impairment, Pulmonary Rehabilitation
Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Impairment focused on measuring lung transplantation, cognition, MOCA, exercise, pulmonary rehabilitation
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.
Sites / Locations
- Yedikule Chest Disease Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pulmonary Rehabilitation
Arm Description
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.
Outcomes
Primary Outcome Measures
Change from baseline distance covered in six minute walking test at 3-months.
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.
Secondary Outcome Measures
Change from baseline 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.
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 3-months
Full Information
NCT ID
NCT03528447
First Posted
May 7, 2018
Last Updated
November 4, 2022
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03528447
Brief Title
The Effect of Pulmonary Rehabilitation on Cognitive Status in Lung Transplantation Candidates
Official Title
The Effect of Pulmonary Rehabilitation on Cognitive Status in Lung Transplantation Candidates
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 20, 2018 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Pulmonary Rehabilitation
Keywords
lung transplantation, cognition, MOCA, exercise, pulmonary rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary Rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline distance covered in six minute walking test at 3-months.
Time Frame
6 minute
Title
Change from baseline The Montreal Cognitive Assessment (MoCA) at 3-months
Description
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.
Time Frame
15 minute
Secondary Outcome Measure Information:
Title
Change from baseline modified Medical Council Dyspnea score at 3-months
Description
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.
Time Frame
5 minute
Title
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 3-months
Time Frame
20 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Yedikule Chest Disease Hospital
City
Istanbul
State/Province
Zeytinburnu
ZIP/Postal Code
34200
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
The Effect of Pulmonary Rehabilitation on Cognitive Status in Lung Transplantation Candidates
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