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Идёт набор NCT06286891

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

— Наблюдательное Chronic Thromboembolic Pulmonary Hypertension Physical Disability Fragility

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Chronic Thromboembolic Pulmonary Hypertension, Physical Disability, Fragility. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бразилия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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).

Подробное описание

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.

Первичные конечные точки

  • To investigate changes in physical performance measured by Six-Minute Walk Test. [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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. [Срок оценки: 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: [Срок оценки: 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: [Срок оценки: 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) [Срок оценки: 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]
Вторичные конечные точки (2)
  • To explore potential preoperative and immediate postoperative risk factors as predictors of functional loss. [Срок оценки: Baseline (one day before the surgery) during the immediate postoperative period.]
  • To investigate changes in hemodynamic and respiratory variables during the funcional tests. [Срок оценки: Immediateley before and after each functional test.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Бразилия · 1 центр
  • Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de S — São Paulo

Идентификаторы

NCT: NCT06286891 · CAAE: 73520523.7.0000.0068

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗