Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Thromboembolic Pulmonary Hypertension, Physical Disability, Fragility. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients: an Observational and Prospective Clinical Study
Overview
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.
Primary outcome measures
- 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.]
- 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.]
- 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]
- 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]
- 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]
- 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]
Secondary outcome measures (2)
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Brazil · 1 center
- Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de S — São Paulo
Identifiers
NCT: NCT06286891 · CAAE: 73520523.7.0000.0068