The Effect of Pulmonary Rehabilitation on Cognitive Status in Lung Transplantation Candidates
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03528447|
Recruitment Status : Active, not recruiting
First Posted : May 17, 2018
Last Update Posted : December 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Impairment Pulmonary Rehabilitation||Other: Pulmonary Rehabilitation||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Pulmonary Rehabilitation on Cognitive Status in Lung Transplantation Candidates|
|Actual Study Start Date :||May 20, 2018|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||September 1, 2020|
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.
Other: Pulmonary Rehabilitation
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.
- Change from baseline distance covered in six minute walking test at 3-months. [ Time Frame: 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.
- 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.
- Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 3-months [ Time Frame: 20 minute ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528447
|Yedikule Chest Disease Hospital|
|Istanbul, Zeytinburnu, Turkey, 34200|