跳至主要内容
临床试验/NCT07747337
NCT07747337招募中不适用

Respiratory, Limb Muscle Properties, and Physical Performance in Adult Lung Transplant Recipients

University of Florida1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年2月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
1
主要终点
Diaphragm structure

研究概览

简要总结

The goal of this observational study is to evaluate respiratory and limb muscle properties in adults awaiting lung transplantation and determine how these measures relate to physical performance, symptoms, and recovery after transplantation. Respiratory and limb muscle weakness may contribute to impaired mobility, frailty, and delayed postoperative recovery, but their specific role in lung transplant candidates is not well understood. Participants will undergo muscle ultrasound imaging at weekly basis, respiratory and limb strength testing, physical performance assessments, and symptom questionnaires once before and after transplantation. Researchers will also collect information from medical records regarding intensive care unit stay, hospital length of stay, rehabilitation participation, and postoperative recovery outcomes.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older.
  • Hospitalized as potential candidates for single- or bilateral-lung transplant surgery.
  • Hemodynamically stable for out-of-bed mobilization

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Respiratory and Limb Muscle Assessment (Diagnostic Test)

结局指标

主要结局

Diaphragm structure

时间窗: Weekly from baseline through postoperative day 14 (±2 days)

Diaphragm thickness (unit of measure: mm) assessed by ultrasonography

Respiratory Muscle Strength

时间窗: 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.

Abdominal muscle structure

时间窗: Baseline through postoperative day 14 (±2 days)

Rectus abdominis muscle thickness (measurement unit: mm) assessed by ultrasonography.

Limb muscle strength

时间窗: At the first baseline visit and postoperative day 14 (±2 days)

Handgrip force and knee extension force measured using dynamometry.

Rectus femoris thickness

时间窗: Baseline through postoperative day 14 (±2 days)

Rectus femoris muscle thickness (unit of measurement: mm) assessed by ultrasonography.

次要结局

  • Five-Repetition Sit-to-Stand Test(Baseline and hospital discharge)
  • Frailty Status(Baseline and at postoperative day 14 (±2 days))
  • patient-reported symptoms(Baseline and at postoperative day 14 (±2 days))
  • Six-Minute Walk Distance(Baseline and at hospital discharge, an average of 3 weeks after surgery.)
  • Anxiety(Baseline and at hospital discharge, up to an average of 3 weeks after surgery.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验