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

Physical Disability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06286891
• Other study ID #: CAAE: 73520523.7.0000.0068
• Status: Recruiting
• Start date: February 29, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: University of Sao Paulo General Hospital
• Contact: Rafael M Ianotti, PT
• Phone: +55 11 26615319
• Email: rafael.ianotti[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Fragility
• Frailty
• Hypertension, Pulmonary
• Physical Disability

Locations

Country	Name	City	State
Brazil	Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB).	Measure: global score	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.
Primary	To investigate changes in physical performance by 1-minute sit-to-stand test (1-MSTST).	Measure: number of 1-MSTST repetitions.	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
Primary	To investigate changes in peripheral muscle strength.	Measure: hand grip strengh (Kgf).	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
Primary	To investigate changes in respiratory muscle strength:	Measures: manovacuometry (cmH2O)	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
Primary	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
Primary	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.	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	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.	Baseline (one day before the surgery) during the immediate postoperative period.
Secondary	To investigate changes in hemodynamic and respiratory variables during the funcional tests.		Immediateley before and after each functional test.