Cognitive Impairment Clinical Trial
Official title:
Does Cognitive Status Affect Pulmonary Rehabilitation Gains?
Verified date | January 2024 |
Source | Istanbul Medipol University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | December 1, 2025 |
Est. primary completion date | December 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Yedikule Chest Disease Hospital | Istanbul | Zeytinburnu |
Lead Sponsor | Collaborator |
---|---|
Istanbul Medipol University Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline the 6 minutes walk distance at 3 months. | The test was conducted in a 30-m corridor in line with American Thoracic Society (ATS) guidelines. Patients were told that they should walk as fast as they can walk in 6 minutes time. | 3 months | |
Primary | Change from Baseline the Montreal Cognitive Assessment (MoCA) test score at 3 months. | It 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). The MoCA is scored by obtaining an item total and the authors recommend a clinical cutoff score of 23. | 3 months | |
Secondary | Change from Baseline the 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. | 3 months | |
Secondary | Change from Baseline the Forced Expiratory Volume in 1 second (FEV1) at 3 months. | It was conducted using the Sensor Medics model 2400 (Yorba Linda, CA,USA), according to the ATS guidelines. | 3 months |
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