Pulmonary HypertensionNCT07206173
Londrina Activities of Daily Living Protocol in Pulmonary Hypertension
An observational study of Pulmonary Hypertension, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study is to evaluate the validity and reliability of the Londrina Daily Living Activities Protocol in patients diagnosed with pulmonary hypertension (PH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- The Londrina Activites of Daily Living Protocol
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 20 Apr 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients being diagnosed with pulmonary hypertension (PH)
Who may be able to join
- Being diagnosed with pulmonary hypertension (PH)
- Being 18 years of age or older
- Agreeing to participate in the study
Who cannot join
- Acute decompensated heart failure
- Orthopedic or neurological disorders that prevent the test from being performed
- Patients who have difficulty understanding the instructions given
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Validity and Reliability of the Londrina Activities of Daily Living Protocol in Patients With Pulmonary Hypertension
The aim of this observational study is to evaluate the validity and reliability of the Londrina Daily Living Activities Protocol in patients diagnosed with pulmonary hypertension (PH).
Read the detailed description
Pulmonary hypertension (PH) is a progressive cardiopulmonary disorder characterized by elevated pulmonary artery pressure, which can lead to right ventricular dysfunction and ultimately heart failure. Right heart catheterization is used to diagnose the disease, and individuals are diagnosed with PH when the mean pulmonary artery pressure is 20 mmHg or higher. The most common and most prominent symptom at diagnosis that prompts referral of PH patients for medical intervention is dyspnea. Dyspnea affects even mild cases of PH, and exertional dyspnea is present in most patients. This significantly impacts patients' functional capacity, quality of life, and overall survival. Even in mild PH, numerous pathological changes contribute significantly to exercise limitation. The multifactorial pathophysiology of exercise limitation in PH involves the circulatory, respiratory, and peripheral muscle systems.
Given the multifaceted nature of pulmonary hypertension and its profound effects on daily functioning, a comprehensive assessment tool is needed to accurately evaluate daily living activities in this patient population. Accurate and reliable assessment of activities of daily living (ADL) is of great importance in the management of pulmonary hypertension, considering the impact of the disease on function. Decreased exercise tolerance in PH, along with reduced quality of life, including physical function and mental health, and decreased physical activity levels, affects every aspect of daily life, placing a significant "disease burden" on the patient.
Quality of life can be assessed primarily using two methods: performance-based tests, which observe the individual's performance while performing standardized activities, and questionnaires, which measure limitations based on the individual's own statements. Performance-based tests offer the advantage of observing the individual's actual performance and identifying potential limitations that may occur during these activities.
The Londrina Activities of Daily Living Protocol is an assessment protocol that aims to evaluate daily living activities and has undergone validity and reliability studies in diseases such as chronic obstructive pulmonary disease, systemic sclerosis, and asthma.
The aim of this study is to evaluate the validity and reliability of the Londrina Activities of Daily Living Protocol in PH.
- Conditions
- Pulmonary Hypertension
- Being tested
- The Londrina Activites of Daily Living Protocol
- Keywords
- Londrina Activities of Daily Living Protocol, Pulmonary Hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Londrina Activites of Daily Living ProtocolOther
The Londrina Activites of Daily Living Protocol is a performance-based test protocol that objectively evaluates ADL. The participant was instructed to perform the tasks at the stations at the same speed they would typically do at home. The protocol consists of five stations with different tasks consisting of arranging objects, walking with weights, organizing objects, organizing clothes and walking.
What is being measured
The primary outcome is the main question the study is designed to answer.
Londrina Activities of Daily Living Protocol
The Londrina ADL protocol will be performed. This protocol consists of a total of 5 stations containing different tasks (arranging objects, walking with weights, organizing objects, organizing clothes and walking). Participants will be asked to perform the tasks at these stations at the speed they would perform them in real life. The duration of the protocol will be recorded in seconds.
The protocol will be repeated using the same method.
Measured: 15 minutes
VO2 (ml/kg/min)
The Londrina ADL protocol will be performed with a mobile ergospirometer (K5, Cosmed). Oxygen consumption (VO2) obtained during the protocol will be recorded.
The protocol will be repeated using the same method as the initial evaluation after the patient has rested for at least 30 minutes.
Measured: 15 minutes
Secondary outcomes (2)
London Chest Activities of Daily Living Scale
It is a questionnaire consisting of fifteen items. Each item is given a score ranging from 0 to 5. Higher scores indicate greater limitation in activities of daily living. The total score can reach a maximum of 75
Measured: 5 minutes
Functional capacity
The 6-minute walk test will be performed.
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start15 Sep 2025
- Primary completion5 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar BASTURK MERC, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206173
- Sponsor's protocol ID
- 2459
- Status last verified
- May 2026
- First submitted
- 17 Sep 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The sharing of this information is restricted by the ethics committee and informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Validity and Reliability of the Londrina Activities of Daily Living Protocol in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT07206173
- Acronym / sponsor ID
- 2459
- Conditions
- Pulmonary Hypertension
- Keywords
- Londrina Activities of Daily Living Protocol, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 5 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 3 Oct 2025 (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.
The aim of this observational study is to evaluate the validity and reliability of the Londrina Daily Living Activities Protocol in patients diagnosed with pulmonary hypertension (PH).
Detailed description
Pulmonary hypertension (PH) is a progressive cardiopulmonary disorder characterized by elevated pulmonary artery pressure, which can lead to right ventricular dysfunction and ultimately heart failure. Right heart catheterization is used to diagnose the disease, and individuals are diagnosed with PH when the mean pulmonary artery pressure is 20 mmHg or higher. The most common and most prominent symptom at diagnosis that prompts referral of PH patients for medical intervention is dyspnea. Dyspnea affects even mild cases of PH, and exertional dyspnea is present in most patients. This significantly impacts patients' functional capacity, quality of life, and overall survival. Even in mild PH, numerous pathological changes contribute significantly to exercise limitation. The multifactorial pathophysiology of exercise limitation in PH involves the circulatory, respiratory, and peripheral muscle systems.
Given the multifaceted nature of pulmonary hypertension and its profound effects on daily functioning, a comprehensive assessment tool is needed to accurately evaluate daily living activities in this patient population. Accurate and reliable assessment of activities of daily living (ADL) is of great importance in the management of pulmonary hypertension, considering the impact of the disease on function. Decreased exercise tolerance in PH, along with reduced quality of life, including physical function and mental health, and decreased physical activity levels, affects every aspect of daily life, placing a significant "disease burden" on the patient.
Quality of life can be assessed primarily using two methods: performance-based tests, which observe the individual's performance while performing standardized activities, and questionnaires, which measure limitations based on the individual's own statements. Performance-based tests offer the advantage of observing the individual's actual performance and identifying potential limitations that may occur during these activities.
The Londrina Activities of Daily Living Protocol is an assessment protocol that aims to evaluate daily living activities and has undergone validity and reliability studies in diseases such as chronic obstructive pulmonary disease, systemic sclerosis, and asthma.
The aim of this study is to evaluate the validity and reliability of the Londrina Activities of Daily Living Protocol in PH.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being diagnosed with pulmonary hypertension (PH)
Key inclusion criteria (3 listed)
- Being diagnosed with pulmonary hypertension (PH)
- Being 18 years of age or older
- Agreeing to participate in the study
Key exclusion criteria (3 listed)
- Acute decompensated heart failure
- Orthopedic or neurological disorders that prevent the test from being performed
- Patients who have difficulty understanding the instructions given
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 |
|---|---|---|
| The Londrina Activites of Daily Living ProtocolThe Londrina Activites of Daily Living Protocol is a performance-based test protocol that objectively evaluates ADL. The participant was instructed to perform the tasks at the stations at the same speed they would typically do at home. The protocol consists of five stations with different tasks consisting of arranging objects, walking with weights, organizing objects, organizing clothes and walking. | Other | – |
Primary outcome
Londrina Activities of Daily Living Protocol
Time frame: 15 minutes
The Londrina ADL protocol will be performed. This protocol consists of a total of 5 stations containing different tasks (arranging objects, walking with weights, organizing objects, organizing clothes and walking). Participants will be asked to perform the tasks at these stations at the speed they would perform them in real life. The duration of the protocol will be recorded in seconds. The protocol will be repeated using the same method.
VO2 (ml/kg/min)
Time frame: 15 minutes
The Londrina ADL protocol will be performed with a mobile ergospirometer (K5, Cosmed). Oxygen consumption (VO2) obtained during the protocol will be recorded. The protocol will be repeated using the same method as the initial evaluation after the patient has rested for at least 30 minutes.
2 secondary outcomes
London Chest Activities of Daily Living Scale
Time frame: 5 minutes
Functional capacity
Time frame: 6 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No. The sharing of this information is restricted by the ethics committee and informed consent form.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Saglik Bilimleri Universitesi 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 11 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Londrina Activities of Daily Living Protocol (time frame: 15 minutes). 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 11 May 2026.