Respiratory Strength Training in Heart Transplant Recipients

Официальное название

Impact of Preoperative Respiratory Strength Training on Postoperative Health for Heart Transplant Recipients

Обзор

This research study is investigating whether completing breathing exercises before surgery helps heart transplant patients recover after surgery. Previous studies have shown that breathing exercises can improve breathing, cough, and swallow function in patients with other diseases/conditions. The current study will investigate the impact of a preoperative respiratory muscle strength training program on breathing and cough function, swallow function, patient-reported eating and swallowing fatigue, and health outcomes in individuals undergoing heart transplantation. Participants will: * undergo tests of breathing, cough, and swallow function * complete questionnaires about the treatment, their swallow function * complete breathing exercises daily

Подробное описание

This study will involve three in-person research evaluations to our lab or in the hospital that will last 45 minutes- 1 hour and will consist of a screening, breathing and cough testing, swallow function testing, and completion of questionnaires. Following the initial research evaluation, individuals will complete daily exercises of active or sham respiratory muscle strength training for several weeks with one telehealth or in-person session per week. The exercises will take 10-15 minutes to complete, and individuals will fill out training logs daily. Prior to transplantation and after completion of the breathing exercises, individuals will undergo a second research evaluation. Then, following surgery, individuals will undergo a third research evaluation and outcomes will be tracked via the electronic health records system.

Вмешательства

• Поведенческое Active respiratory muscle strength training
  Devices will be set to 60% of participants' maximum expiratory pressure and maximum inspiratory pressure. Participants will complete training 7 days per week by performing 5 sets of 5 repetitions for both expiratory and inspiratory muscle strength training (a total of 50 repetitions).
• Поведенческое Sham respiratory muscle strength training
  Springs will be removed from devices to ensure training is done without resistance. Participants will complete training 7 days per week by performing 5 sets of 5 repetitions for both expiratory and inspiratory sham muscle strength training (a total of 50 repetitions).

Первичные конечные точки

• Change in maximum expiratory pressure between pre and post respiratory strength training [Срок оценки: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)]
• Change in maximum inspiratory pressure between pre and post respiratory strength training [Срок оценки: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)]

Вторичные конечные точки (5)

• Change in cough peak expiratory flow between pre and post respiratory strength training [Срок оценки: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)]
• Patient-reported treatment burden [Срок оценки: post-intervention/pre-surgery (an average of 2-6 weeks after baseline)]
• Patient reported swallow function [Срок оценки: pre-surgery (baseline), post-surgery]
• Change in penetration-aspiration scale scores between before and after surgery [Срок оценки: pre-surgery (baseline), post-surgery]
• Change in clinical frailty scale score [Срок оценки: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)]

Критерии участия

Критерии включения

• Adult (18-90 years old)
• Not pregnant
• Undergoing evaluation or actively waitlisted for heart transplantation at VUMC with a waitlist status of 1-6
• Have a computer, tablet or electronic device with a stable internet connection for telehealth sessions (outpatient)
• Be willing to undergo testing procedures and complete the exercise training program.

Критерии исключения

• Individual <18 years old, >90 years old
• Pregnant
• No access to a computer, tablet or electronic device with a stable internet connection for telehealth sessions
• Unwilling or unable to undergo testing procedures and complete the exercise training program.

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

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Vanderbilt University Medical Center — Nashville

Идентификаторы

NCT: NCT06190171 · 232071 · 24CDA1257668

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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