Chronic Thromboembolic Pulmonary HypertensionNCT06286891
Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients
An observational study of Chronic Thromboembolic Pulmonary Hypertension and Physical Disability, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The goal of this observational and prospective study is to investigate changes in physical performance, lung function, respiratory and peripheral muscle strength in patients during the postoperative period following pulmonary endarterectomy (PET). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension, Physical Disability, Fragility
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Feb 2024to 30 Nov 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the preoperative period of elective pulmonary endarterectomy susrgery.
Who may be able to join
- Age ≥ 18 years
- Both genders
- Elective pulmonary endarterectomy surgery
- Absence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the preoperative period.
Who cannot join
- Reoperation for any reason
- Presence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the postoperative period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403-000
Orival Freitas Filho, MD
Fabio B Jatene, MD,PhD
About this study
Official title: Evaluation of Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients: an Observational and Prospective Clinical Study
The goal of this observational and prospective study is to investigate changes in physical performance, lung function, respiratory and peripheral muscle strength in patients during the postoperative period following pulmonary endarterectomy (PET).
Read the detailed description
This study aims to investigate the physical changes in patients undergoing pulmonary endarterectomy (PET). It will observe alterations in physical performance, lung function, and muscle strength during the postoperative period. This study, observational and prospective, will include individuals aged ≥18 scheduled, evaluating them preoperatively, post-intensive care unit discharge, before hospital discharge and after six months . Assessments involve tests like the Six-minute walk test, Short Physical Performance Battery, One-minute sit-to-stand test, manovacuometry, dynamometry, spirometry and Clinical Frailty Scale to identify frailty and measure muscle and lung function. The study also aims to explore predictive variables for functional loss during hospitalization.
- Keywords
- Pulmonary Endarterectomy Surgery, Six-minute walk test, Short Physical Performance Battery, One-minute sit-to-stand test, Muscular strength, Spirometry
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate changes in physical performance measured by Six-Minute Walk Test.
Measures: the assessment will take place in a flat 30-meter corridor, marked every 1 meter with non-slip flooring, and the patient will be instructed to walk for six minutes as fast as possible.
Measured: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery.
To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB).
Measure: global score
Measured: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after surgery.
To investigate changes in physical performance by 1-minute sit-to-stand test (1-MSTST).
Measure: number of 1-MSTST repetitions.
Measured: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
To investigate changes in peripheral muscle strength.
Measure: hand grip strengh (Kgf).
Measured: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
To investigate changes in respiratory muscle strength:
Measures: manovacuometry (cmH2O)
Measured: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
To investigate changes in lung function test measure by spirometry:
Measured: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
To investigate frailty by Clinical Frailty Scale (CFS)
The minimal value is 1 and the maximal is 9 in which the lowest scores mean worse outcomes.
Measured: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
Secondary outcomes (2)
To explore potential preoperative and immediate postoperative risk factors as predictors of functional loss.
Measures: Occurrence of comorbidities and clinical variables associated with functional decline.
Measured: Baseline (one day before the surgery) during the immediate postoperative period.
To investigate changes in hemodynamic and respiratory variables during the funcional tests.
Measured: Immediateley before and after each functional test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start29 Feb 2024
- Primary completion1 Sep 2025
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael M. Ianotti, P.T., Ph.D., University of Sao Paulo General Hospital
- Investigators
- Rafael M Ianotti, PT, Principal investigator, Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286891
- Sponsor's protocol ID
- CAAE: 73520523.7.0000.0068
- Status last verified
- Jun 2026
- First submitted
- 8 Feb 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients: an Observational and Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06286891
- Acronym / sponsor ID
- CAAE: 73520523.7.0000.0068
- Keywords
- Pulmonary Endarterectomy Surgery, Six-minute walk test, Short Physical Performance Battery, One-minute sit-to-stand test, Muscular strength, Spirometry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 29 Feb 2024 (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 goal of this observational and prospective study is to investigate changes in physical performance, lung function, respiratory and peripheral muscle strength in patients during the postoperative period following pulmonary endarterectomy (PET).
Detailed description
This study aims to investigate the physical changes in patients undergoing pulmonary endarterectomy (PET). It will observe alterations in physical performance, lung function, and muscle strength during the postoperative period. This study, observational and prospective, will include individuals aged ≥18 scheduled, evaluating them preoperatively, post-intensive care unit discharge, before hospital discharge and after six months . Assessments involve tests like the Six-minute walk test, Short Physical Performance Battery, One-minute sit-to-stand test, manovacuometry, dynamometry, spirometry and Clinical Frailty Scale to identify frailty and measure muscle and lung function. The study also aims to explore predictive variables for functional loss during hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the preoperative period of elective pulmonary endarterectomy susrgery.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Both genders
- Elective pulmonary endarterectomy surgery
- Absence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the preoperative period.
Key exclusion criteria (2 listed)
- Reoperation for any reason
- Presence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the postoperative period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To investigate changes in physical performance measured by Six-Minute Walk Test.
Time frame: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery.
Measures: the assessment will take place in a flat 30-meter corridor, marked every 1 meter with non-slip flooring, and the patient will be instructed to walk for six minutes as fast as possible.
To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB).
Time frame: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after surgery.
Measure: global score
To investigate changes in physical performance by 1-minute sit-to-stand test (1-MSTST).
Time frame: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
Measure: number of 1-MSTST repetitions.
To investigate changes in peripheral muscle strength.
Time frame: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
Measure: hand grip strengh (Kgf).
To investigate changes in respiratory muscle strength:
Time frame: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
Measures: manovacuometry (cmH2O)
To investigate changes in lung function test measure by spirometry:
Time frame: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
To investigate frailty by Clinical Frailty Scale (CFS)
Time frame: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
The minimal value is 1 and the maximal is 9 in which the lowest scores mean worse outcomes.
2 secondary outcomes
To explore potential preoperative and immediate postoperative risk factors as predictors of functional loss.
Time frame: Baseline (one day before the surgery) during the immediate postoperative period.
To investigate changes in hemodynamic and respiratory variables during the funcional tests.
Time frame: Immediateley before and after each functional test.
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 22 Jun 2026.
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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.
Rafael M Ianotti, PT principal investigator
Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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 Chronic Thromboembolic Pulmonary Hypertension and Physical Disability, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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: looking for participants now, as of the sponsor's last update on 22 Jun 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 Brazil. 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?
Contact Rafael M Ianotti, PT (+55 11 26615319, rafael.ianotti@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate changes in physical performance measured by Six-Minute Walk Test. (time frame: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery.). The study lists 7 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 22 Jun 2026.