Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients
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: Music.
- Кому может быть актуально
- Состояния в реестре: Heart Failure. 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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Обзор
The study aims to assess the effect of music on the heart resulting in a change in their exercise capacity among systolic heart failure patients undergoing Cardiopulmonary Exercise testing.
Подробное описание
Studies have previously shown the positive impact of music on the autonomic nervous system, neurohormonal and cardiovascular system. In addition, a previously published study found a positive impact of music resulting in an improvement of quality of life (QOL) in heart failure patients. Proposed mechanisms of benefit of music in heart failure include a reduction in sympathetic activity, and modulation of parasympathetic activity. Further, reduction in anxiety and arterial relaxation are thought to be beneficial effects of music. It is hypothesized that heart failure patients listening to music would have better exercise stress test performance and increased exercise time.
Adult patients with systolic heart failure scheduled to undergo Cardiopulmonary Exercise (CPX) testing at the Gill Heart and Vascular Institute will be recruited.
While the patients are undergoing Cardiopulmonary exercise testing, patients randomized to the 'music arm' will listen to pre-selected upbeat music during their duration of the exercise testing via headphones that will be provided to patients by the study personnel. The patients who are randomized to 'non-music arm' in which their headphones will not play music and the patients will perform the cardiopulmonary exercise testing as usual.
Standard clinical care is performing cardiopulmonary exercise testing without any music.
The investigators will then compare the results of CPX study of the two arms to assess the impact of music on exercise performance.
Вмешательства
- Другое Music
Patients randomized to the music group will listen to upbeat music using headphones.
Первичные конечные точки
- Difference in O2 consumption (VO2) [L/min] [Срок оценки: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)]
- Difference in CO2 production (VCO2) [L/min] [Срок оценки: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)]
- Difference in respiratory exchange ratio (RER) [Срок оценки: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)]
- Difference in Minute Ventilation (VE) [L/min] [Срок оценки: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)]
- Difference in Ventilatory Threshold (VT) [L] [Срок оценки: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)]
- Difference in respiratory rate (RR) [Breaths per minute] [Срок оценки: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)]
- Difference in Ventilatory Equivalent of CO2 (VE/VCO2) [Срок оценки: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)]
Вторичные конечные точки (5)
- Difference in Heart Rate [Beats per minute] [Срок оценки: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)]
- Difference in O2 Pulse [ml] [Срок оценки: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)]
- Difference in Systolic and Diastolic Blood Pressure [mmHg] [Срок оценки: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)]
- Difference in Exercise time [mm:ss] [Срок оценки: 15 minutes (Start to end of CPX study)]
- Difference in Work rate [watt] [Срок оценки: 15 minutes (Start to end of each CPX study)]
Критерии участия
Критерии включения
- Adults (age >18 years)
- Able to consent
- English speaking
Критерии исключения
- Severe hearing deficiency
- Unable to exercise.
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
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- University of Kentucky — Lexington
Идентификаторы
NCT: NCT05537467 · 76503