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

30 juli 2026 bijgewerkt door: University of Florida
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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Respiratory and peripheral muscle dysfunction are common in individuals with advanced lung disease awaiting lung transplantation. Muscle weakness, atrophy, and impaired contractile function may contribute to reduced physical performance, frailty, symptom burden, and delayed recovery after transplantation. Although physical function tests provide an overall assessment of performance, they provide limited information regarding specifics of respiratory and limb muscle impairments. Ultrasound imaging is a noninvasive and reliable method to evaluate muscle structure, quality, and contractile function and has been associated with clinical outcomes in several critically ill populations, including prolonged mechanical ventilation, longer intensive care unit (ICU) and hospital stays, and increased morbidity.

The purpose of this study is to characterize respiratory and limb muscle properties before and after lung transplantation and determine how these measures relate to physical performance, patient-reported outcomes, and postoperative recovery. Respiratory muscle function will be assessed using maximal respiratory pressure testing and ultrasound evaluation of the diaphragm and abdominal muscles. Limb muscle function will be assessed using ultrasound imaging and strength testing of the quadriceps muscles. Physical performance, frailty, dyspnea, pain, fatigue, anxiety, and ICU/hospital-related outcomes will also be evaluated.

The central hypothesis of this study is that respiratory and limb muscle weakness, atrophy, and impaired contractile function are associated with poorer physical performance, greater symptom burden, and delayed postoperative recovery after lung transplantation. To test this hypothesis, a prospective observational study of adult lung transplant candidates will be conducted from their hospital admission to their post-operative day 14. Participants will undergo serial ultrasound imaging assessments before transplantation and during the early postoperative period along with symptom questionnaires; while respiratory and limb strength testing, functional assessments, symptom questionnaires will be collected on the first and last day of research visit. Collection of ICU and hospital outcomes will occur from the electronic medical record. The central hypothesis will be evaluated through the following aims:

Aim 1: Evaluate relationships between respiratory strength and ultrasound measurements of contractile dysfunction in candidates awaiting lung transplant.

Aim 2: Characterize the associations between respiratory and limb muscle properties (atrophy, strength), physical performance, and patient-centered outcomes (dyspnea, frailty, pain, fatigue, and anxiety) in pre-lung transplant candidates.

Aim 3: Identify the influence of preoperative respiratory and quadriceps contractile function on the early postoperative mobility progression in lung transplant recipients Aim 4: Determine relationships between postoperative diaphragm dysfunction and functional status at hospital discharge

Studietype

Observationeel

Inschrijving (Geschat)

36

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Barbara K Smith, PhD, PT
  • Telefoonnummer: 352-294-5315
  • E-mail: bksmith@ufl.edu

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Florida
      • Gainesville, Florida, Verenigde Staten, 32608
        • Werving
        • UF Health Shands Medical Center
        • Contact:
        • Contact:
          • Mohammad A. Aladaileh, MBBS, MRCSI, EBCTS, FRCSIC-Th
          • Telefoonnummer: (352) 265-5470
          • E-mail: maladaileh@ufl.edu
        • Hoofdonderzoeker:
          • Barbara K Smith, PhD
        • Onderonderzoeker:
          • Wagner Souza Leite, PT
        • Onderonderzoeker:
          • Sandra Morgan, RN, PhD
        • Onderonderzoeker:
          • Jessica Cornman, PT
        • Onderonderzoeker:
          • May Smith-Hublou, PhD, CCC-SLP
        • Onderonderzoeker:
          • Ushna Khan, MD
        • Onderonderzoeker:
          • Amir M Emtiazjoo, MD, MSc
        • Onderonderzoeker:
          • Marc O Maybauer, MD, PhD, EDIC, FCCP, FACC, FAS

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Diagnostische toets: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Diaphragm structure
Tijdsspanne: Weekly from baseline through postoperative day 14 (±2 days)
Diaphragm thickness (unit of measure: mm) assessed by ultrasonography
Weekly from baseline through postoperative day 14 (±2 days)
Respiratory Muscle Strength
Tijdsspanne: 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.
Baseline and at postoperative day 14 (±2 days)
Abdominal muscle structure
Tijdsspanne: Baseline through postoperative day 14 (±2 days)
Rectus abdominis muscle thickness (measurement unit: mm) assessed by ultrasonography.
Baseline through postoperative day 14 (±2 days)
Limb muscle strength
Tijdsspanne: At the first baseline visit and postoperative day 14 (±2 days)
Handgrip force and knee extension force measured using dynamometry.
At the first baseline visit and postoperative day 14 (±2 days)
Rectus femoris thickness
Tijdsspanne: Baseline through postoperative day 14 (±2 days)
Rectus femoris muscle thickness (unit of measurement: mm) assessed by ultrasonography.
Baseline through postoperative day 14 (±2 days)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Five-Repetition Sit-to-Stand Test
Tijdsspanne: Baseline and hospital discharge
Time required to complete five sit-to-stand repetitions as a measure of physical performance. Retrieved from the medical record.
Baseline and hospital discharge
Frailty Status
Tijdsspanne: Baseline and at postoperative day 14 (±2 days)
Frailty assessed using the Clinical Frailty Scale (CFS), a 9-point scale ranging from 1 to 9, where 1 = Very Fit and 9 = Terminally Ill. Higher scores indicate greater frailty and a worse clinical status.
Baseline and at postoperative day 14 (±2 days)
patient-reported symptoms
Tijdsspanne: Baseline and at postoperative day 14 (±2 days)
Dyspnea, physical fatigue, and pain assessed using an 11-point numeric rating scale ranging from 0 to 10, where 0 indicates no symptom and 10 indicates the worst symptom severity ever experienced. Higher scores indicate worse symptom burden.
Baseline and at postoperative day 14 (±2 days)
Six-Minute Walk Distance
Tijdsspanne: Baseline and at hospital discharge, an average of 3 weeks after surgery.
Distance walked during the Six-Minute Walk Test (6MWT), retrieved from the medical record.
Baseline and at hospital discharge, an average of 3 weeks after surgery.
Anxiety
Tijdsspanne: Baseline and at hospital discharge, up to an average of 3 weeks after surgery.
Anxiety assessed using the State-Trait Anxiety Inventory (STAI). The STAI score ranges from 20 to 80, with higher scores indicating greater anxiety and a worse outcome. Data will be retrieved from the medical record.
Baseline and at hospital discharge, up to an average of 3 weeks after surgery.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Duration of Mechanical Ventilation
Tijdsspanne: From surgery through hospital discharge, up to an average of 3 weeks after surgery.
Total duration of postoperative invasive mechanical ventilation, measured in days.
From surgery through hospital discharge, up to an average of 3 weeks after surgery.
Intensive Care Unit Length of Stay
Tijdsspanne: From ICU admission through ICU discharge, up to an average of two weeks after surgery.
Number of days from intensive care unit (ICU) admission to ICU discharge.
From ICU admission through ICU discharge, up to an average of two weeks after surgery.
Hospital Length of Stay
Tijdsspanne: From ICU admission through hospital discharge, up to an average of 3 weeks after surgery.
Number of days from ICU admission to hospital discharge
From ICU admission through hospital discharge, up to an average of 3 weeks after surgery.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Florida

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 februari 2026

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 juli 2027

Studieregistratiedata

Eerst ingediend

27 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 juli 2026

Eerst geplaatst (Werkelijk)

5 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

30 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB202501059

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Participant data that underlie the results reported in this article after deidentification.

IPD-tijdsbestek voor delen

9 months and ending 36 months following article publication.

IPD-toegangscriteria voor delen

Investigators whose proposed use of the data has been approved by an independent review committee.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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