Clinical trial NCT06286891: Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients
Official title: Evaluation of Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients: an Observational and Prospective Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Physical Disability
Fragility
Keywords: Pulmonary Endarterectomy Surgery
Six-minute walk test
Short Physical Performance Battery
One-minute sit-to-stand test
Muscular strength
Spirometry
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in the preoperative period of elective pulmonary endarterectomy susrgery.

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.

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.

Primary outcomes:
measure: To investigate changes in physical performance measured by Six-Minute Walk Test.
timeFrame: 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: To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB).
timeFrame: 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: To investigate changes in physical performance by 1-minute sit-to-stand test (1-MSTST).
timeFrame: 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: To investigate changes in peripheral muscle strength.
timeFrame: 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: To investigate changes in respiratory muscle strength:
timeFrame: 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: To investigate changes in lung function test measure by spirometry:
timeFrame: 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: To investigate frailty by Clinical Frailty Scale (CFS)
timeFrame: 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:
measure: To explore potential preoperative and immediate postoperative risk factors as predictors of functional loss.
timeFrame: Baseline (one day before the surgery) during the immediate postoperative period.
measure: To investigate changes in hemodynamic and respiratory variables during the funcional tests.
timeFrame: Immediateley before and after each functional test.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
affiliation: Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
name: Rafael M Ianotti, PT
role: PRINCIPAL_INVESTIGATOR
References: