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Набор по приглашению NCT06931886

Pulmonary Hypertension Inspiratory Training

Без фазы С лечением Pulmonary Hypertension

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: Inspiratory Muscle Strength Training.
Кому может быть актуально
Состояния в реестре: Pulmonary Hypertension. 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
США
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

Effects of Inspiratory Muscle Strength Training on Pulmonary Hypertension: A Six Week Study

Обзор

This study is examining the effects of six weeks of inspiratory muscle strength training (IMST) on outcomes related to pulmonary hypertension. This study leverages previous cardiopulmonary exercise test (CPET) results and a pre-existing upcoming CPET to examine the effects of IMST on cardiopulmonary pressures and exercise tolerance and ability.

Подробное описание

PH is a condition characterized by abnormally high blood pressure in the lungs (i.e., pulmonary arterial pressure), which impacts heart function and reduces exercise tolerance. This study will assess whether six weeks of a breathing exercise called IMST can improve heart and lung function as well as exercise capacity for individuals with PH.

For this study, patients will be asked to perform IMST for the six weeks prior to their next scheduled clinical standard of care assessment of their PH. The goal of this study is to determine whether IMST reduces pulmonary arterial pressure and improves exercise tolerance in individuals with PH. This study will be minimally invasive, as it simply adds a safe, well-tolerated, non-invasive respiratory training to the participants' standard of care and leverages their existing PH assessment data to evaluate the impact of IMST on PH.

Вмешательства

  • Другое Inspiratory Muscle Strength Training
    Participants will be asked to inhale against a resistance. This resistance will be set to \~55% of their maximal inspiratory ability. Participants will complete 5 sets of 6 breaths (30 total) a day for 5 days a week for 6 weeks.

Первичные конечные точки

  • Pulmonary arterial pressure [Срок оценки: The data will be obtained from previous medical records of patient visits occurring up to 8 months prior to enrollment and at the end of treatment at 6 weeks post enrollment. .]
  • Cardiac Output [Срок оценки: The data will be obtained from previous medical records of patient visits occurring up to 8 months prior to enrollment and at the end of treatment, which occurs 6 weeks post-initiation.]
  • Maximal Oxygen Uptake [Срок оценки: The data will be obtained from previous medical records of patient visits occurring up to 8 months prior to enrollment and at the end of treatment at 6 weeks post enrollment. .]

Критерии участия

Критерии включения

  • Diagnosed with PH defined by clinical guideline criteria
  • Must already be scheduled for a clinical assessment of their PH within 8 weeks of enrolling in the study.
  • Must have undergone an assessment of their PH in the last 18 months with no major changes in PH management or medication within that period.

Критерии исключения

  • Current smoker or have smoked in the last 10 years
  • Unable or unwilling to undergo routine functional testing of their PH (i.e., 6-minute walk distance).
  • Presence of significant cardiovascular or respiratory conditions other than PH, including but not limited to:
  • Chronic obstructive pulmonary disease
  • Severe asthma
  • Severe ischemic heart disease
  • Left-sided heart failure
  • History of a major cardiovascular event, such as a myocardial infarction or stroke, within the last 6 months
  • Individuals with an implanted pacemaker or other significant cardiac devices
  • History of neurological, respiratory, head and neck, or thoracic surgeries, or conditions such as a collapsed lung or perforated eardrum
  • Pregnant individuals or those actively trying to become pregnant
  • Individuals with any of the following: chronic laryngitis, chronic bronchitis, emphysema, pneumonia, tuberculosis, chronic cough, extremely high blood pressure (>170/100), neurological problems, scoliosis, organ transplants, HIV or other immunocompromising conditions, or autoimmune disease.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • University of Arizona — Tucson

Идентификаторы

NCT: NCT06931886 · STUDY00005343

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗