Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients

Evaluation of Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients: an Observational and Prospective Clinical Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06286891

Enrollment

Registered

2024-02-29

Start date

2024-02-29

Completion date

2026-11-30

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Thromboembolic Pulmonary Hypertension, Fragility, Physical Disability

Keywords

Pulmonary Endarterectomy Surgery, Six-minute walk test, Short Physical Performance Battery, One-minute sit-to-stand test, Muscular strength, Spirometry

Brief 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).

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* Reoperation for any reason * Presence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the postoperative period.

Design outcomes

Primary

Measure	Time frame	Description
To investigate changes in physical performance measured by Six-Minute Walk Test.	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).	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).	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.	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:	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:	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)	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.

Secondary

Measure	Time frame	Description
To explore potential preoperative and immediate postoperative risk factors as predictors of functional loss.	Baseline (one day before the surgery) during the immediate postoperative period.	Measures: Occurrence of comorbidities and clinical variables associated with functional decline.
To investigate changes in hemodynamic and respiratory variables during the funcional tests.	Immediateley before and after each functional test.	—

Countries

Brazil

Contacts

CONTACTRafael M Ianotti, PT

rafael.ianotti@hc.fm.usp.br+55 11 26615319

PRINCIPAL_INVESTIGATORRafael M Ianotti, PT

Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Outcome results