Respiratory, Limb Muscle Properties, and Physical Performance in Adult Lung Transplant Recipients
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Respiratory and peripheral muscle dysfunction are common in individuals with advanced lung disease awaiting lung transplantation. Muscle weakness, atrophy, and impaired contractile function may contribute to reduced physical performance, frailty, symptom burden, and delayed recovery after transplantation. Although physical function tests provide an overall assessment of performance, they provide limited information regarding specifics of respiratory and limb muscle impairments. Ultrasound imaging is a noninvasive and reliable method to evaluate muscle structure, quality, and contractile function and has been associated with clinical outcomes in several critically ill populations, including prolonged mechanical ventilation, longer intensive care unit (ICU) and hospital stays, and increased morbidity.
The purpose of this study is to characterize respiratory and limb muscle properties before and after lung transplantation and determine how these measures relate to physical performance, patient-reported outcomes, and postoperative recovery. Respiratory muscle function will be assessed using maximal respiratory pressure testing and ultrasound evaluation of the diaphragm and abdominal muscles. Limb muscle function will be assessed using ultrasound imaging and strength testing of the quadriceps muscles. Physical performance, frailty, dyspnea, pain, fatigue, anxiety, and ICU/hospital-related outcomes will also be evaluated.
The central hypothesis of this study is that respiratory and limb muscle weakness, atrophy, and impaired contractile function are associated with poorer physical performance, greater symptom burden, and delayed postoperative recovery after lung transplantation. To test this hypothesis, a prospective observational study of adult lung transplant candidates will be conducted from their hospital admission to their post-operative day 14. Participants will undergo serial ultrasound imaging assessments before transplantation and during the early postoperative period along with symptom questionnaires; while respiratory and limb strength testing, functional assessments, symptom questionnaires will be collected on the first and last day of research visit. Collection of ICU and hospital outcomes will occur from the electronic medical record. The central hypothesis will be evaluated through the following aims:
Aim 1: Evaluate relationships between respiratory strength and ultrasound measurements of contractile dysfunction in candidates awaiting lung transplant.
Aim 2: Characterize the associations between respiratory and limb muscle properties (atrophy, strength), physical performance, and patient-centered outcomes (dyspnea, frailty, pain, fatigue, and anxiety) in pre-lung transplant candidates.
Aim 3: Identify the influence of preoperative respiratory and quadriceps contractile function on the early postoperative mobility progression in lung transplant recipients Aim 4: Determine relationships between postoperative diaphragm dysfunction and functional status at hospital discharge
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Barbara K Smith, PhD, PT
- Número de teléfono: 352-294-5315
- Correo electrónico: bksmith@ufl.edu
Copia de seguridad de contactos de estudio
- Nombre: Wagner Souza Leite, PT
- Número de teléfono: (352) 273-6085
- Correo electrónico: wagnersouzaleite@ufl.edu
Ubicaciones de estudio
-
-
Florida
-
Gainesville, Florida, Estados Unidos, 32608
- Reclutamiento
- UF Health Shands Medical Center
-
Contacto:
- Mindaugas Rackauskas, MD, PhD
- Número de teléfono: (352) 265-5470
- Correo electrónico: mindaugas.Rackauskas@surgery.ufl.edu
-
Contacto:
- Mohammad A. Aladaileh, MBBS, MRCSI, EBCTS, FRCSIC-Th
- Número de teléfono: (352) 265-5470
- Correo electrónico: maladaileh@ufl.edu
-
Investigador principal:
- Barbara K Smith, PhD
-
Sub-Investigador:
- Wagner Souza Leite, PT
-
Sub-Investigador:
- Sandra Morgan, RN, PhD
-
Sub-Investigador:
- Jessica Cornman, PT
-
Sub-Investigador:
- May Smith-Hublou, PhD, CCC-SLP
-
Sub-Investigador:
- Ushna Khan, MD
-
Sub-Investigador:
- Amir M Emtiazjoo, MD, MSc
-
Sub-Investigador:
- Marc O Maybauer, MD, PhD, EDIC, FCCP, FACC, FAS
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 18 years or older.
- Hospitalized as potential candidates for single- or bilateral-lung transplant surgery.
- Hemodynamically stable for out-of-bed mobilization
Exclusion Criteria:
- Baseline cognitive impairment
- History of previous solid organ transplantation or thoracic surgery
- Existing phrenic nerve lesion
- Lower limb amputation or fracture
- External fixators or open wounds of the lower extremities
- Diagnosed neuromuscular disorder.
- Morbid obesity (body mass index >45 kg/m²).
- Any other medical condition that, in the opinion of the investigators, would make participation unsuitable.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Adult Lung Transplant Candidates
adults enrolled for in-hospital evaluation for lung transplant and listed for surgery who undergo serial assessments of respiratory and limb muscle properties before transplantation and during the early postoperative period.
Assessments include ultrasound imaging, respiratory and limb strength testing, physical performance measures, patient-reported outcomes, and collection of clinical outcomes from the medical record.
|
Participants undergo serial assessments of respiratory and limb muscle structure and function before and after lung transplantation.
Assessments include ultrasound imaging of the diaphragm, rectus abdominis, and quadriceps muscles; respiratory muscle strength testing; handgrip strength testing; knee extension strength testing; physical performance measures; and patient-reported outcome questionnaires.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Diaphragm structure
Periodo de tiempo: Weekly from baseline through postoperative day 14 (±2 days)
|
Diaphragm thickness (unit of measure: mm) assessed by ultrasonography
|
Weekly from baseline through postoperative day 14 (±2 days)
|
|
Respiratory Muscle Strength
Periodo de tiempo: Baseline and at postoperative day 14 (±2 days)
|
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) obtained during maximal respiratory efforts against a one-way valve.
|
Baseline and at postoperative day 14 (±2 days)
|
|
Abdominal muscle structure
Periodo de tiempo: Baseline through postoperative day 14 (±2 days)
|
Rectus abdominis muscle thickness (measurement unit: mm) assessed by ultrasonography.
|
Baseline through postoperative day 14 (±2 days)
|
|
Limb muscle strength
Periodo de tiempo: At the first baseline visit and postoperative day 14 (±2 days)
|
Handgrip force and knee extension force measured using dynamometry.
|
At the first baseline visit and postoperative day 14 (±2 days)
|
|
Rectus femoris thickness
Periodo de tiempo: Baseline through postoperative day 14 (±2 days)
|
Rectus femoris muscle thickness (unit of measurement: mm) assessed by ultrasonography.
|
Baseline through postoperative day 14 (±2 days)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Five-Repetition Sit-to-Stand Test
Periodo de tiempo: Baseline and hospital discharge
|
Time required to complete five sit-to-stand repetitions as a measure of physical performance.
Retrieved from the medical record.
|
Baseline and hospital discharge
|
|
Frailty Status
Periodo de tiempo: Baseline and at postoperative day 14 (±2 days)
|
Frailty assessed using the Clinical Frailty Scale (CFS), a 9-point scale ranging from 1 to 9, where 1 = Very Fit and 9 = Terminally Ill.
Higher scores indicate greater frailty and a worse clinical status.
|
Baseline and at postoperative day 14 (±2 days)
|
|
patient-reported symptoms
Periodo de tiempo: Baseline and at postoperative day 14 (±2 days)
|
Dyspnea, physical fatigue, and pain assessed using an 11-point numeric rating scale ranging from 0 to 10, where 0 indicates no symptom and 10 indicates the worst symptom severity ever experienced.
Higher scores indicate worse symptom burden.
|
Baseline and at postoperative day 14 (±2 days)
|
|
Six-Minute Walk Distance
Periodo de tiempo: Baseline and at hospital discharge, an average of 3 weeks after surgery.
|
Distance walked during the Six-Minute Walk Test (6MWT), retrieved from the medical record.
|
Baseline and at hospital discharge, an average of 3 weeks after surgery.
|
|
Anxiety
Periodo de tiempo: Baseline and at hospital discharge, up to an average of 3 weeks after surgery.
|
Anxiety assessed using the State-Trait Anxiety Inventory (STAI).
The STAI score ranges from 20 to 80, with higher scores indicating greater anxiety and a worse outcome.
Data will be retrieved from the medical record.
|
Baseline and at hospital discharge, up to an average of 3 weeks after surgery.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Duration of Mechanical Ventilation
Periodo de tiempo: From surgery through hospital discharge, up to an average of 3 weeks after surgery.
|
Total duration of postoperative invasive mechanical ventilation, measured in days.
|
From surgery through hospital discharge, up to an average of 3 weeks after surgery.
|
|
Intensive Care Unit Length of Stay
Periodo de tiempo: From ICU admission through ICU discharge, up to an average of two weeks after surgery.
|
Number of days from intensive care unit (ICU) admission to ICU discharge.
|
From ICU admission through ICU discharge, up to an average of two weeks after surgery.
|
|
Hospital Length of Stay
Periodo de tiempo: From ICU admission through hospital discharge, up to an average of 3 weeks after surgery.
|
Number of days from ICU admission to hospital discharge
|
From ICU admission through hospital discharge, up to an average of 3 weeks after surgery.
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Parry SM, El-Ansary D, Cartwright MS, Sarwal A, Berney S, Koopman R, Annoni R, Puthucheary Z, Gordon IR, Morris PE, Denehy L. Ultrasonography in the intensive care setting can be used to detect changes in the quality and quantity of muscle and is related to muscle strength and function. J Crit Care. 2015 Oct;30(5):1151.e9-14. doi: 10.1016/j.jcrc.2015.05.024. Epub 2015 Jun 3.
- Maury G, Langer D, Verleden G, Dupont L, Gosselink R, Decramer M, Troosters T. Skeletal muscle force and functional exercise tolerance before and after lung transplantation: a cohort study. Am J Transplant. 2008 Jun;8(6):1275-81. doi: 10.1111/j.1600-6143.2008.02209.x. Epub 2008 Apr 29.
- Kelm DJ, Bonnes SL, Jensen MD, Eiken PW, Hathcock MA, Kremers WK, Kennedy CC. Pre-transplant wasting (as measured by muscle index) is a novel prognostic indicator in lung transplantation. Clin Transplant. 2016 Mar;30(3):247-55. doi: 10.1111/ctr.12683. Epub 2016 Feb 11.
- Huh S, Cho WH, Kim D, Son BS, Yeo HJ. Clinical impact of preoperative diaphragm dysfunction on early outcomes and ventilation function in lung transplant: a single-center retrospective study. J Intensive Care. 2022 May 15;10(1):23. doi: 10.1186/s40560-022-00614-7.
- LoMauro A, Righi I, Privitera E, Vergari M, Nigro M, Aliverti A, Frykholm P, Tarsia P, Morlacchi L, Nosotti M, Palleschi A. The impaired diaphragmatic function after bilateral lung transplantation: A multifactorial longitudinal study. J Heart Lung Transplant. 2020 Aug;39(8):795-804. doi: 10.1016/j.healun.2020.04.010. Epub 2020 Apr 21.
- Rozenberg D, Wickerson L, Singer LG, Mathur S. Sarcopenia in lung transplantation: a systematic review. J Heart Lung Transplant. 2014 Dec;33(12):1203-12. doi: 10.1016/j.healun.2014.06.003. Epub 2014 Jun 9.
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
Otros números de identificación del estudio
- IRB202501059
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .