NCT07747337 · University of Florida
Respiratory, Limb Muscle Properties, and Physical Performance in Adult Lung Transplant Recipients
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Respiratory and Limb Muscle Assessment
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Gainesville, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 5, 2026 · Source of record for eligibility and locations