Respiratory, Limb Muscle Properties, and Physical Performance in Adult Lung Transplant Recipients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older.
Hospitalized as potential candidates for single- or bilateral-lung transplant surgery.
Hemodynamically stable for out-of-bed mobilization
Disqualifiers
Baseline cognitive impairment
History of previous solid organ transplantation or thoracic surgery
Existing phrenic nerve lesion
Lower limb amputation or fracture
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Respiratory and Limb Muscle Assessment
Diagnostic testParticipants 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.
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Adult Lung Transplant Candidates1 intervention
Trial outcomes
Primary outcomes
1
Diaphragm structure
Diaphragm thickness (unit of measure: mm) assessed by ultrasonography
Time frame
Weekly from baseline through postoperative day 14 (±2 days)2
Respiratory Muscle Strength
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) obtained during maximal respiratory efforts against a one-way valve.
Time frame
Baseline and at postoperative day 14 (±2 days)3
Abdominal muscle structure
Rectus abdominis muscle thickness (measurement unit: mm) assessed by ultrasonography.
Time frame
Baseline through postoperative day 14 (±2 days)4
Limb muscle strength
Handgrip force and knee extension force measured using dynamometry.
Time frame
At the first baseline visit and postoperative day 14 (±2 days)Secondary outcomes
1
Five-Repetition Sit-to-Stand Test
Time required to complete five sit-to-stand repetitions as a measure of physical performance. Retrieved from the medical record.
Time frame
Baseline and hospital discharge2
Frailty Status
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.
Time frame
Baseline and at postoperative day 14 (±2 days)3
patient-reported symptoms
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.
Time frame
Baseline and at postoperative day 14 (±2 days)4
Six-Minute Walk Distance
Distance walked during the Six-Minute Walk Test (6MWT), retrieved from the medical record.
Time frame
Baseline and at hospital discharge, an average of 3 weeks after surgery.Other outcomes
1
Duration of Mechanical Ventilation
Total duration of postoperative invasive mechanical ventilation, measured in days.
Time frame
From surgery through hospital discharge, up to an average of 3 weeks after surgery.2
Intensive Care Unit Length of Stay
Number of days from intensive care unit (ICU) admission to ICU discharge.
Time frame
From ICU admission through ICU discharge, up to an average of two weeks after surgery.3
Hospital Length of Stay
Number of days from ICU admission to hospital discharge
Time frame
From ICU admission through hospital discharge, up to an average of 3 weeks after surgery.Sponsors and contacts
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Source ClinicalTrials.gov