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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 : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
esra pehlivan, Istanbul Medipol University Hospital

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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Pulmonary Rehabilitation Other: Pulmonary Rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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.
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.





Primary Outcome Measures :
  1. Change from baseline distance covered in six minute walking test at 3-months. [ Time Frame: 6 minute ]
  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 3-months [ Time Frame: 20 minute ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Turkey
Yedikule Chest Disease Hospital
Istanbul, Zeytinburnu, Turkey, 34200
Sponsors and Collaborators
Istanbul Medipol University Hospital
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Responsible Party: esra pehlivan, Principal investigator, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier: NCT03528447    
Other Study ID Numbers: PR_cognition
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by esra pehlivan, Istanbul Medipol University Hospital:
lung transplantation
cognition
MOCA
exercise
pulmonary rehabilitation
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders