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

NCT06286891 | Recruiting

• 1 other identifier: CAAE: 73520523.7.0000.0068
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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

• 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

• 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

• 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)

  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 Outcomes (2)

• 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.

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

  Immediateley before and after each functional test.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in the preoperative period of elective pulmonary endarterectomy susrgery.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Study Officials

• Rafael M Ianotti, PT

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafael M Ianotti, PT

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Coordinator - Physiotherapy Division - Heart Institute (InCor)

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 29, 2024
• Study Start: February 29, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 28, 2025

Record last verified: 2024-05

Locations

BR (1)