Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT07747337

Conditions

Lung Transplantation

End Stage Lung Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Respiratory and Limb Muscle Assessment

Study Details

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.

Conditions

Lung Transplantation

End Stage Lung Disease

Study ID

NCT07747337

Start date

Feb 5, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • Diaphragm structure [ Time Frame: Weekly from baseline through postoperative day 14 (±2 days) ]
  • Respiratory Muscle Strength [ Time Frame: Baseline and at postoperative day 14 (±2 days) ]
  • Abdominal muscle structure [ Time Frame: Baseline through postoperative day 14 (±2 days) ]
  • Limb muscle strength [ Time Frame: At the first baseline visit and postoperative day 14 (±2 days) ]
  • Rectus femoris thickness [ Time Frame: Baseline through postoperative day 14 (±2 days) ]

Central Contacts and Locations

Central contacts

Barbara K Smith, PhD, PT

352-294-5315bksmith@ufl.edu

Wagner Souza Leite, PT

(352) 273-6085wagnersouzaleite@ufl.edu

Locations

UF Health Shands Medical Center

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Mindaugas Rackauskas, MD, PhD

(352) 265-5470mindaugas.Rackauskas@surgery.ufl.edu

Mohammad A. Aladaileh, MBBS, MRCSI, EBCTS, FRCSIC-Th

(352) 265-5470maladaileh@ufl.edu

Principal Investigator:

Barbara K Smith, PhD

More Information

Sponsor

University of Florida

Last update posted

Aug 5, 2026

Last verified

Jul, 2026

Keywords

  • lung transplant candidates
  • diaphragm ultrasound
  • limb muscles ultrasound
  • respiratory muscles
  • quadriceps muscles
  • rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-08-05.