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

30 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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

Type d'étude

Observationnel

Inscription (Estimé)

36

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Barbara K Smith, PhD, PT
  • Numéro de téléphone: 352-294-5315
  • E-mail: bksmith@ufl.edu

Sauvegarde des contacts de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Test diagnostique: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Diaphragm structure
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Five-Repetition Sit-to-Stand Test
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Duration of Mechanical Ventilation
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Florida

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

5 février 2026

Achèvement primaire (Estimé)

1 décembre 2026

Achèvement de l'étude (Estimé)

1 juillet 2027

Dates d'inscription aux études

Première soumission

27 juillet 2026

Première soumission répondant aux critères de contrôle qualité

30 juillet 2026

Première publication (Réel)

5 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRB202501059

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

9 months and ending 36 months following article publication.

Critères d'accès au partage IPD

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

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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