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

NCT07747337 | Recruiting

• 1 other identifier: IRB202501059
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Diaphragm structure

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

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

• Respiratory Muscle Strength

  Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) obtained during maximal respiratory efforts against a one-way valve.

  Baseline and at postoperative day 14 (±2 days)

• Abdominal muscle structure

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

  Baseline through postoperative day 14 (±2 days)

• Limb muscle strength

  Handgrip force and knee extension force measured using dynamometry.

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

• Rectus femoris thickness

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

  Baseline through postoperative day 14 (±2 days)

Secondary Outcomes (5)

• 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.

Other Outcomes (3)

• Duration of Mechanical Ventilation

  From surgery through hospital discharge, up to an average of 3 weeks after surgery.

• Intensive Care Unit Length of Stay

  From ICU admission through ICU discharge, up to an average of two weeks after surgery.

• Hospital Length of Stay

  From ICU admission through hospital discharge, up to an average of 3 weeks after surgery.

Study Arms (1)

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.

Diagnostic Test: Respiratory and Limb Muscle Assessment

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.

Adult Lung Transplant Candidates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult lung transplant candidates receiving care at UF Shands hospital. Participants are individuals with advanced lung disease undergoing evaluation and treatment while awaiting lung transplantation in the hospital. The study population includes adults who are able to complete study assessments of respiratory and limb muscle function before transplantation and during the early postoperative recovery period.

You may qualify if:

• years or older.
• Hospitalized as potential candidates for single- or bilateral-lung transplant surgery.
• Hemodynamically stable for out-of-bed mobilization

You may not qualify 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health Shands Medical Center

Gainesville, Florida, 32608, United States

RECRUITING

Related Publications (6)

• Maury G, Langer D, Verleden G, Dupont L, Gosselink R, Decramer M, Troosters T. Skeletal muscle force and functional exercise tolerance before and after lung transplantation: a cohort study. Am J Transplant. 2008 Jun;8(6):1275-81. doi: 10.1111/j.1600-6143.2008.02209.x. Epub 2008 Apr 29.

  PMID: 18444941 BACKGROUND

• Parry SM, El-Ansary D, Cartwright MS, Sarwal A, Berney S, Koopman R, Annoni R, Puthucheary Z, Gordon IR, Morris PE, Denehy L. Ultrasonography in the intensive care setting can be used to detect changes in the quality and quantity of muscle and is related to muscle strength and function. J Crit Care. 2015 Oct;30(5):1151.e9-14. doi: 10.1016/j.jcrc.2015.05.024. Epub 2015 Jun 3.

  PMID: 26211979 BACKGROUND

• Huh S, Cho WH, Kim D, Son BS, Yeo HJ. Clinical impact of preoperative diaphragm dysfunction on early outcomes and ventilation function in lung transplant: a single-center retrospective study. J Intensive Care. 2022 May 15;10(1):23. doi: 10.1186/s40560-022-00614-7.

  PMID: 35570300 BACKGROUND

• LoMauro A, Righi I, Privitera E, Vergari M, Nigro M, Aliverti A, Frykholm P, Tarsia P, Morlacchi L, Nosotti M, Palleschi A. The impaired diaphragmatic function after bilateral lung transplantation: A multifactorial longitudinal study. J Heart Lung Transplant. 2020 Aug;39(8):795-804. doi: 10.1016/j.healun.2020.04.010. Epub 2020 Apr 21.

  PMID: 32362476 BACKGROUND

• Kelm DJ, Bonnes SL, Jensen MD, Eiken PW, Hathcock MA, Kremers WK, Kennedy CC. Pre-transplant wasting (as measured by muscle index) is a novel prognostic indicator in lung transplantation. Clin Transplant. 2016 Mar;30(3):247-55. doi: 10.1111/ctr.12683. Epub 2016 Feb 11.

  PMID: 26701203 BACKGROUND

• Rozenberg D, Wickerson L, Singer LG, Mathur S. Sarcopenia in lung transplantation: a systematic review. J Heart Lung Transplant. 2014 Dec;33(12):1203-12. doi: 10.1016/j.healun.2014.06.003. Epub 2014 Jun 9.

  PMID: 25044057 BACKGROUND

MeSH Terms

Interventions

Respiratory Rate

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Barbara K Smith, PhD, PT

CONTACT

352-294-5315; bksmith@ufl.edu

Wagner Souza Leite, PT

CONTACT

(352) 273-6085; wagnersouzaleite@ufl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 5, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee.

Locations

US (1)