What this study is
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.
What's being tested
- Respiratory and Limb Muscle Assessment
Intervention · DIAGNOSTIC TEST
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.
Study details
- Sponsor
- University of Florida
- Conditions
- Lung Transplantation · End Stage Lung Disease
- Enrolling
- 36 people
- Starts
- 2026-02-05
- Est. completion
- 2027-07
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 18 years or older.
- Hospitalized as potential candidates for single- or bilateral-lung transplant surgery.
- Hemodynamically stable for out-of-bed mobilization
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openUF Health Shands Medical Center
Gainesville, Florida, United States
- Mindaugas Rackauskas, MD, PhD · Contact(352) 265-5470mindaugas.Rackauskas@surgery.ufl.edu
- Mohammad A. Aladaileh, MBBS, MRCSI, EBCTS, FRCSIC-Th · Contact(352) 265-5470maladaileh@ufl.edu
- Barbara K Smith, PhD · Principal investigator
- Wagner Souza Leite, PT · Sub-investigator
- Sandra Morgan, RN, PhD · Sub-investigator
- Jessica Cornman, PT · Sub-investigator
- May Smith-Hublou, PhD, CCC-SLP · Sub-investigator
- Ushna Khan, MD · Sub-investigator
- Amir M Emtiazjoo, MD, MSc · Sub-investigator
- Marc O Maybauer, MD, PhD, EDIC, FCCP, FACC, FAS · Sub-investigator
Recruiting
Study team
Sponsor
University of Florida
Study ID IRB202501059
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.