Skip to main content
Clinical Trials/NCT07747337
NCT07747337RecruitingNot Applicable

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

University of Florida1 site in 1 country36 target enrollmentStarted: February 5, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
36
Locations
1
Primary Endpoint
Diaphragm structure

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Intervention: Respiratory and Limb Muscle Assessment (Diagnostic Test)

Outcomes

Primary Outcomes

Diaphragm structure

Time Frame: Weekly from baseline through postoperative day 14 (±2 days)

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

Respiratory Muscle Strength

Time Frame: 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

Time Frame: Baseline through postoperative day 14 (±2 days)

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

Limb muscle strength

Time Frame: At the first baseline visit and postoperative day 14 (±2 days)

Handgrip force and knee extension force measured using dynamometry.

Rectus femoris thickness

Time Frame: Baseline through postoperative day 14 (±2 days)

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

Secondary Outcomes

  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials