Cognitive ImpairmentNCT03740867
Does Cognitive Status Affect Pulmonary Rehabilitation Gains?
A study testing Pulmonary rehabilitation in people with Cognitive Impairment and Pulmonary Rehabilitation, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cognitive Impairment, Pulmonary Rehabilitation
- What is being tested?
- Pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Nov 2018to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Failure to complete the planned exercise program for any reason,
- Not to be literate.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yedikule Chest Disease Hospital
Istanbul, Zeytinburnu, 34200
About this study
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.
Read the 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 cognitive status to pulmonary rehabilitation gains in lung transplant candidates.
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 council 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.
- Conditions
- Cognitive Impairment, Pulmonary Rehabilitation
- Being tested
- Pulmonary rehabilitation
- Keywords
- Cognitive Impairment, pulmonary rehabilitation, exercise, MOCA, aerobic training
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationOther
Exercise program includes aerobic (walking band, bicycle, arm ergometer) and strengthening (with free weights) components.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | Those with poor cognition (MOCA score<23)
The patients 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. Receives: Other: Pulmonary rehabilitation |
| Group2 | Experimental | Those with good cognition (MOCA score≥23)
The patients 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. Receives: Other: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start13 Nov 2018
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esra pehlivan, Istanbul Medipol University Hospital
- Investigators
- Esra Pehlivan, PhD, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740867
- Sponsor's protocol ID
- Cognition_PR
- Status last verified
- Apr 2025
- First submitted
- 2 Nov 2018
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Cognitive Status Affect Pulmonary Rehabilitation Gains?
- ClinicalTrials.gov ID
- NCT03740867
- Acronym / sponsor ID
- Cognition_PR
- Conditions
- Cognitive Impairment, Pulmonary Rehabilitation
- Keywords
- Cognitive Impairment, pulmonary rehabilitation, exercise, MOCA, aerobic training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 cognitive status to pulmonary rehabilitation gains in lung transplant candidates.
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 council 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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Other: Pulmonary rehabilitationThose with poor cognition (MOCA score<23) The patients 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. |
| Group2 | Experimental | Other: Pulmonary rehabilitationThose with good cognition (MOCA score≥23) The patients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Failure to complete the planned exercise program for any reason,
- Not to be literate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitationExercise program includes aerobic (walking band, bicycle, arm ergometer) and strengthening (with free weights) components. | Other | Group1, Group2 |
Primary outcome
Change from Baseline the 6 minutes walk distance at 3 months.
Time frame: 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.
Change from Baseline the Montreal Cognitive Assessment (MoCA) test score at 3 months.
Time frame: 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.
2 secondary outcomes
Change from Baseline the modified Medical Council Dyspnea score at 3 months.
Time frame: 3 months
Change from Baseline the Forced Expiratory Volume in 1 second (FEV1) at 3 months.
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra Pehlivan, PhD principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation in people with Cognitive Impairment and Pulmonary Rehabilitation, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline the 6 minutes walk distance at 3 months. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.