Меню
Идёт набор NCT05381818

Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery

Без фазы С лечением Arthropathy of Knee Arthropathy of Hip Lower Extremity Fracture Orthopedic Disorder

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
В протоколе указаны: Daily Inspiratory Muscle Training (dIMT), Acute Inspiratory Muscle Training (aIMT), Standard of Care (SOC).
Кому может быть актуально
Состояния в реестре: Arthropathy of Knee, Arthropathy of Hip, Lower Extremity Fracture, Orthopedic Disorder. Базовые параметры: 18 лет — 100 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Preoperative Inspiratory Muscle Strength Training and Pulmonary Complications After Surgery

Обзор

The purpose of this research study is to evaluate effects of respiratory strengthening exercises on breathing function, in people who have orthopedic surgery. It is known that breathing function decreases for a few days after surgery. in In this study, we want to see if exercising before surgery strengthens the breathing muscles and improves recovery after surgery.

Подробное описание

Preoperative inspiratory muscle training (IMT) has been shown to reduce post operative complications (PPC's) following prolonged cardiac surgeries, but its potential benefits have not been investigated in shorter surgeries with expected brief post-operative hospitalizations. We intend to address this unmet need by investigating preoperative IMT, an evidence-based rehab strategy to optimize lung function, prior to total joint arthroplasty surgery. The fundamental hypothesis guiding this proposal is that preoperative IMT will attenuate post-operative declines in breathing function and offset PPCs. To test this hypothesis, we will conduct a single center, randomized, prospective pilot study. Adults scheduled for total joint arthroplasty or lower extremity orthopedic surgery will be randomized to either complete daily IMT in advance of surgery (dIMT), a single acute IMT session immediately before surgery (aIMT), or usual surgical standard of care (SOC). Inspiratory muscle strength and pulmonary function will be evaluated upon enrollment \~4 weeks in advance of surgery and in pre-operative holding, and post-operative declines will be investigated through the first 24 hours (Aim 1). Further, we will investigate the effect of training assignment on post-operative clinical outcomes (Aim 2).

Вмешательства

  • Поведенческое Daily Inspiratory Muscle Training (dIMT)
    Daily IMT training sessions for 2-4 weeks prior to surgery
  • Поведенческое Acute Inspiratory Muscle Training (aIMT)
    A single session of IMT provided within 30 minutes prior to anesthesia induction.
  • Другое Standard of Care (SOC)
    Standard of care only pre and post-operatively.

Первичные конечные точки

  • Maximal Inspiratory Pressure (MIP) [Срок оценки: 24-hours post-op.]
  • Forced vital capacity (FVC) [Срок оценки: 24-hours postoperative changes]
Вторичные конечные точки (1)
  • Post operative pulmonary complications [Срок оценки: 10 days Post-op]

Критерии участия

Критерии включения

  • 18 or older
  • History of current or previous tobacco use (including vaping containing nicotine products)
  • One or more risk factors for post operative pulmonary complications including history of current or previous tobacco use, a clinically diagnosed lung disease, shortness of breath with minimal exertion, FEV1 or FVC less than 80% than predicted or respiratory muscles strength below lower limit of normal for age and sex.
  • History of smoking related lung disease
  • Projected surgical time > 30 minutes
  • Ability to follow instructions to complete IMT exercises
  • Ability to communicate adverse effects such as pain or fatigue or the need for assistance

Критерии исключения

  • American Society of Anesthesiologists physical status classification of 4 or greater .
  • Recent history of acute pneumonia or lower respiratory infection in the previous two weeks requiring acute corticosteroid or antibiotic medication,
  • Preoperative dependence on continuous supplemental oxygen dependence.
  • Preoperative dependence on positive pressure breathing support while awake and upright (night time CPAP permitted),
  • Diagnosis of a neurologic condition (i.e. MS, ALS, Parkinson's, stroke),
  • Participating in a pulmonary rehabilitation program
  • Severe obstructive pulmonary disease (Classification of Global Initiative for Chronic Obstructive Lung Disease (GOLD) 3 or higher, indicating FEV1<50% predicted.
  • Patients with an infectious disease requiring isolation (i.e. COVID-19).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • University of Florida — Jacksonville

Идентификаторы

NCT: NCT05381818 · IRB202102681 · R21AG083667

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗