Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo General Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Reoperation for any reason
Presence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the postoperative period.
Trial population
Patients in the preoperative period of elective pulmonary endarterectomy susrgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
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.2
To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB).
Measure: global score
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.3
To investigate changes in physical performance by 1-minute sit-to-stand test (1-MSTST).
Measure: number of 1-MSTST repetitions.
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 surgery4
To investigate changes in peripheral muscle strength.
Measure: hand grip strengh (Kgf).
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 surgerySecondary outcomes
1
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.
Time frame
Baseline (one day before the surgery) during the immediate postoperative period.2
To investigate changes in hemodynamic and respiratory variables during the funcional tests.
Time frame
Immediateley before and after each functional test.Sponsors and contacts
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Source ClinicalTrials.gov