Entrenamiento de fuerza respiratoria en receptores de trasplantes de corazón
Impacto del entrenamiento de la fuerza respiratoria preoperatoria en la salud posoperatoria de los receptores de trasplantes de corazón
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Cara Donohue, Ph.D.
- Número de teléfono: 615-852-5085
- Correo electrónico: cara.donohue@vumc.org
Ubicaciones de estudio
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Reclutamiento
- Vanderbilt University Medical Center
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Contacto:
- Cara Donohue
- Número de teléfono: 615-852-5085
- Correo electrónico: cara.donohue@vumc.org
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Contacto:
- Jill Cable
- Número de teléfono: 615-852-5085
- Correo electrónico: irad.lab@vumc.org
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Active respiratory muscle strength training
Enrolled heart transplant patients will undergo active preoperative respiratory strength training using two respiratory strength training devices from enrollment until they receive a heart transplant. |
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). |
|
Comparador falso: Sham respiratory muscle strength training
Enrolled heart transplant patients will undergo sham preoperative respiratory strength training using two respiratory strength training devices from enrollment until they receive a heart transplant. For individuals completing sham respiratory strength training, the spring will be removed from the devices as has been done in prior sham-controlled trials. |
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). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in maximum expiratory pressure between pre and post respiratory strength training
Periodo de tiempo: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
A measure of respiratory strength while breathing out |
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
Periodo de tiempo: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
A measure of respiratory strength while breathing in |
baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in cough peak expiratory flow between pre and post respiratory strength training
Periodo de tiempo: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
A measure of cough strength |
baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
|
Patient-reported treatment burden
Periodo de tiempo: post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
Patients will complete the exercise therapy burden questionnaire (ETBQ). Scores on the ETBQ range from 0-100 with higher scores indicating greater burden. |
post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
|
Patient reported swallow function
Periodo de tiempo: pre-surgery (baseline), post-surgery
|
Patients will complete the swallowing and eating related fatigue (SERF) questionnaire. Scores on the SERF range from 0-48 with higher scores indicating greater impairment. |
pre-surgery (baseline), post-surgery
|
|
Change in penetration-aspiration scale scores between before and after surgery
Periodo de tiempo: pre-surgery (baseline), post-surgery
|
The penetration aspiration scale is a validated 8-point ordinal rating scale that measures the depth of airway invasion and the patient's response during swallowing. Scores range from 1 to 8 with a score of 1 indicating a safe swallow (best score) and 8 indicating silent aspiration (worst score). |
pre-surgery (baseline), post-surgery
|
|
Change in clinical frailty scale score
Periodo de tiempo: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
The Clinical Frailty Scale (CFS) is a measure of physical function. Scores on the CFS range from 1-9 with higher scores indicating greater impairment. |
baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Cara Donohue, Ph.D., Vanderbilt University Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades de las vías respiratorias
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Trastornos de la respiración
- Enfermedades esofágicas
- Enfermedades Otorrinolaringológicas
- Signos y Síntomas Respiratorios
- Enfermedades faríngeas
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Aspiración Respiratoria
- Trastornos de la deglución
- Tos
Otros números de identificación del estudio
- 232071
- 24CDA1257668 (Otro número de subvención/financiamiento: American Heart Association)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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