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Идёт набор NCT05962164

Passive Heat Therapy for People With COPD

Без фазы С лечением COPD Cardiovascular Diseases

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: Passive Heat Therapy, Sham Immersion.
Кому может быть актуально
Состояния в реестре: COPD, Cardiovascular Diseases. Базовые параметры: от 40 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
Канада
Следующий шаг
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Официальное название

The Acute and Chronic Benefits of Passive Heat Therapy for People With COPD

Обзор

People with Chronic Obstructive Pulmonary Disease (COPD) often develop high blood pressure and heart disease due to their sedentary lifestyle and difficulty exercising. The investigators will test if heating can mimic the health benefits of exercise by monitoring the increase in leg blood-flow using ultrasound during a 45-minute hot-water footbath. The patients will then undergo 6-weeks of hot-water footbaths to examine whether the changes to blood-flow lead to improvements in blood pressure and other indicators of heart disease risk.

Подробное описание

People with COPD are at higher risk of developing cardiovascular disease (CVD). While exercise training is a potent therapy for CVD, people with COPD have a low tolerance for exercise due to dyspnea and premature muscle fatigue. Thus, there is a need to develop more effective strategies to improve CVD risk in people with COPD. A novel way to reduce blood pressure and enhance arterial health is with passive heat therapy (PHT). An acute 45-min bout of lower limb hot-water immersion has been shown to increase leg blood flow and reduce blood pressure in healthy older adults, suggesting that PHT could have similar hypotensive and anti-atherosclerotic effects as exercise. Augmenting leg blood flow with PHT may also have functional benefits by reducing peripheral muscle fatigue and improving exercise tolerance. No study to date has looked at the acute and chronic hemodynamic and vascular responses to PHT in people with COPD, nor whether it can acutely or chronically improve exercise tolerance.

Вмешательства

  • Поведенческое Passive Heat Therapy
    The intervention will consist of 6 weeks of repeated (3x/week) 45-min lower-leg immersions.
  • Поведенческое Sham Immersion
    The sham intervention will consist of 6 weeks of repeated (3x/week) 45-min lower-leg immersions.

Первичные конечные точки

  • Mean 24-hour ambulatory blood pressure following chronic passive heat therapy [Срок оценки: 6 weeks]
Вторичные конечные точки (5)
  • Flow mediated dilation of the superficial femoral artery following chronic passive heat therapy. [Срок оценки: 6 weeks]
  • Arterial stiffness following chronic passive heat therapy [Срок оценки: 6 weeks]
  • Exercise tolerance following chronic passive heat therapy [Срок оценки: 6 weeks]
  • The acute changes in leg blood flow from a single bout of passive heat therapy [Срок оценки: During procedure: 60-minutes]
  • The acute changes in superficial femoral artery shear stress from a single bout of passive heat therapy [Срок оценки: During procedure: 60-minutes]

Критерии участия

Критерии включения

  • Non-smoking individuals
  • >40 years of age
  • Stable (exacerbation free for >6 weeks), moderate-to-severe COPD (post bronchodilator FEV1/FVC <lower limit of normal and FEV1 z-score <2.51)

Критерии исключения

  • Performing structured exercise training (i.e. pulmonary rehabilitation)
  • Have advanced cardiac or cerebrovascular disease (i.e. a history of heart failure, previous stroke or myocardial infarction)
  • Have uncontrolled hypertension (>160/95 mmHg at rest)
  • Have hypotension (<110/60 mmHg)
  • Are taking Beta Blockers
  • Regularly (>1/week) have hot baths (>30 min) or use a hot tub or sauna.

Exclusion Criteria for exercise outcomes:

  • Have resting blood pressure > 150/95 mmHg
  • On supplemental oxygen for hypoxemia.
  • Musculoskeletal pain that limits their ability to perform stationary cycling.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • University of British Columbia — Kelowna

Идентификаторы

NCT: NCT05962164 · H21-01868

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗