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NCT Number: NCT06286891

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

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).

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Key information

Conditions

Chronic Thromboembolic Pulmonary Hypertension Fragility Physical Disability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

São Paulo, 05403-000, Brazil

Location status: Recruiting

Location contact

Fabio B Jatene, MD,PhD

SUB_INVESTIGATOR

Kelly CO Abud, PT, PhD

SUB_INVESTIGATOR

Orival Freitas Filho, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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).

  5. 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)

  6. 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

  7. 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.

Secondary outcomes

  1. 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.

    Measures: Occurrence of comorbidities and clinical variables associated with functional decline.

  2. To investigate changes in hemodynamic and respiratory variables during the funcional tests.

    Time frame: Immediateley before and after each functional test.

Study contacts

Contact information is provided by the study sponsor or research team.

Rafael M Ianotti, PT

CONTACT

[email protected]

+55 11 26615319

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 29, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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