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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07747337
Status
Recruiting
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Conditions

  • End Stage Lung Disease
  • Lung Transplantation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Respiratory and Limb Muscle Assessment — 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

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.

Key Dates

First listed
Aug 5, 2026
Start date
Feb 5, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
36 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Diaphragm structure [ Time Frame: Weekly from baseline through postoperative day 14 (±2 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UF Health Shands Medical CenterGainesvilleFlorida32608
Mindaugas Rackauskas, MD, PhD
[email protected]
(352) 265-5470
Mohammad A. Aladaileh, MBBS, MRCSI, EBCTS, FRCSIC-Th
[email protected]
(352) 265-5470
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)

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By research site
UF Health Shands Medical Center· Gainesville, FL

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