Меню
Идёт набор NCT06951620

Optimizing Aerobic Fitness in Older Adults

Без фазы С лечением Aerobic Capacity High Intensity Interval Training

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: HIIT, MICT.
Кому может быть актуально
Состояния в реестре: Aerobic Capacity, High Intensity Interval Training. Базовые параметры: от 65 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

Optimizing Aerobic Fitness and Functional Response to Exercise in Older Adults

Обзор

Hospitalization and treatment for cardiovascular disease is one of the main contributors to disability in older adults. Moderate intensity continuous aerobic and resistance training have been the cornerstone of cardiac rehabilitation (CR) for decades to remediate hospital-acquired functional deficits, but some groups receive less or minimal functional benefit from this training. The proposed studies seek to optimize recovery of aerobic fitness and physical function among older cardiac patients using a novel high intensity training regimen with the long-term goal of reducing subsequent disability and improving clinical outcomes.

Подробное описание

Clinical events and hospitalization often initiate disability in older adults with cardiovascular disease (CVD) being the primary cause of hospital acquired disability. Cardiac rehabilitation (CR) was designed to correct this disability, with moderate intensity, continuous aerobic training (MICT) as its foundation but some patients, including older adults, receive less functional benefit from MICT. Attention has recently focused on high intensity interval aerobic training (HIIT) as an alternative to MICT because it improves aerobic fitness to a greater extent and is safe and feasible for older adults enrolled in CR; however, neither HIIT nor MICT address age-related atrophy and weakness. Resistance training is a core component of CR meant to correct these deficits, but the moderate intensity resistance training (MIRT) most commonly used has minimal effects on these outcomes. Thus, there is an unmet clinical need for multi-modal exercise interventions that address the unique needs of older adult patients enrolled in CR to optimize improvements in functional recovery and clinical outcomes.

The investigators will conduct the first direct comparison of HIIT+HIRT to MICT+MIRT to improve VO2peak and physical function in older men and women enrolled in CR.

Aim 1: Determine the efficacy of combined HIIT+HIRT vs MICT+MIRT to increase VO2peak in older adult patients enrolled in CR Aim 2: Determine the efficacy of combined HIIT+HIRT vs MICT+MIRT to increase physical function in older adult patients enrolled in CR.

Вмешательства

  • Другое HIIT
    Patients who recently experienced a myocardial infarction (MI) or percutaneous intervention (PCI; angioplasty, stent placement or valve replacement) and enroll in Phase 2 Cardiac Rehabilitation (CR) may be randomized to High intensity training (HIIT)
  • Другое MICT
    Patients who recently experienced a myocardial infarction (MI) or percutaneous intervention (PCI; angioplasty, stent placement or valve replacement) and enroll in Phase 2 Cardiac Rehabilitation (CR) may be randomized to Moderate intensity training

Первичные конечные точки

  • Change in Aerobic fitness [Срок оценки: Within 4 months of the intake assessment]
  • Change in 30 sec sit-to-stand test (STS) [Срок оценки: Within 4 months of the intake assessment]
Вторичные конечные точки (8)
  • Changes in Quality of Life- Cardiac Specific [Срок оценки: Within 4 months of the intake assessment]
  • Changes in Depressive Symptoms [Срок оценки: Within 4 months of the intake assessment]
  • Changes in Executive Function (digit span) [Срок оценки: Within 4 months of the intake assessment]
  • Changes in Executive Function (BRIEF) [Срок оценки: Within 4 months of the intake assessment]
  • Changes in Executive Function (trail making) [Срок оценки: Within 4 months of the intake assessment]
  • Changes in Physical Function (Six Minute Walk Test) [Срок оценки: Within 4 months of the intake assessment]
  • Changes in Enjoyment of Exercise (PACES) [Срок оценки: Within 4 months of the intake assessment]
  • Changes in Anxiety [Срок оценки: Within 4 months of the intake assessment]

Критерии участия

Критерии включения

  • >65 years old
  • ambulatory
  • enrolled in CR at our center following a recent clinical diagnosis of myocardial infarction or percutaneous intervention will be recruited

Критерии исключения

  • have an active malignancy (excluding non-melanoma skin cancer or low grade prostate cancer under surveillance)
  • unwilling to comply with the exercise prescription they may be assigned to
  • have a submaximal performance on entry exercise tolerance test, defined as respiratory exchange ratio <1.0

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
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • UVMMC Cardiac Rehabilitation — South Burlington

Идентификаторы

NCT: NCT06951620 · #STUDY00002693 · R01AG084636

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗