Lung TransplantationNCT07747337
Respiratory, Limb Muscle Properties, and Physical Performance in Adult Lung Transplant Recipients
An observational study of Lung Transplantation and End Stage Lung Disease, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation, End Stage Lung Disease
- What is being tested?
- Respiratory and Limb Muscle Assessment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2026to Jul 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 years or older.
- Hospitalized as potential candidates for single- or bilateral-lung transplant surgery.
- Hemodynamically stable for out-of-bed mobilization
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UF Health Shands Medical Center
Gainesville, Florida, 32608
Mindaugas Rackauskas, MD, PhD, (352) 265-5470, mindaugas.Rackauskas@surgery.ufl.edu
Mohammad A. Aladaileh, MBBS, MRCSI, EBCTS, FRCSIC-Th, (352) 265-5470, maladaileh@ufl.edu
About this study
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.
Read the detailed description
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
- Conditions
- Lung Transplantation, End Stage Lung Disease
- Being tested
- Respiratory and Limb Muscle Assessment
- Keywords
- lung transplant candidates, diaphragm ultrasound, limb muscles ultrasound, respiratory muscles, quadriceps muscles, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory and Limb Muscle AssessmentDiagnostic 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Respiratory and Limb Muscle Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm structure
Diaphragm thickness (unit of measure: mm) assessed by ultrasonography
Measured: 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.
Measured: Baseline and at postoperative day 14 (±2 days)
Abdominal muscle structure
Rectus abdominis muscle thickness (measurement unit: mm) assessed by ultrasonography.
Measured: Baseline through postoperative day 14 (±2 days)
Limb muscle strength
Handgrip force and knee extension force measured using dynamometry.
Measured: 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.
Measured: Baseline through postoperative day 14 (±2 days)
Secondary outcomes (5)
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.
Measured: Baseline and hospital discharge
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.
Measured: Baseline and at postoperative day 14 (±2 days)
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.
Measured: Baseline and at postoperative day 14 (±2 days)
Six-Minute Walk Distance
Distance walked during the Six-Minute Walk Test (6MWT), retrieved from the medical record.
Measured: Baseline and at hospital discharge, an average of 3 weeks after surgery.
Anxiety
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.
Measured: Baseline and at hospital discharge, up to an average of 3 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start5 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747337
- Sponsor's protocol ID
- IRB202501059
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data that underlie the results reported in this article after deidentification.
Publications
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.
PubMed 18444941Parry 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.
PubMed 26211979Huh 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.
PubMed 35570300LoMauro 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.
PubMed 32362476Kelm 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.
PubMed 26701203Rozenberg 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.
PubMed 25044057
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory, Limb Muscle Properties, and Physical Performance in Adult Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT07747337
- Acronym / sponsor ID
- IRB202501059
- Conditions
- Lung Transplantation, End Stage Lung Disease
- Keywords
- lung transplant candidates, diaphragm ultrasound, limb muscles ultrasound, respiratory muscles, quadriceps muscles, rehabilitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Lung Transplant Candidates | – | Diagnostic Test: Respiratory and Limb Muscle Assessmentadults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 18 years or older.
- Hospitalized as potential candidates for single- or bilateral-lung transplant surgery.
- Hemodynamically stable for out-of-bed mobilization
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory and Limb Muscle AssessmentParticipants 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. | Diagnostic test | Adult Lung Transplant Candidates |
Primary outcome
Diaphragm structure
Time frame: Weekly from baseline through postoperative day 14 (±2 days)
Diaphragm thickness (unit of measure: mm) assessed by ultrasonography
Respiratory Muscle Strength
Time frame: 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.
Abdominal muscle structure
Time frame: Baseline through postoperative day 14 (±2 days)
Rectus abdominis muscle thickness (measurement unit: mm) assessed by ultrasonography.
Limb muscle strength
Time frame: At the first baseline visit and postoperative day 14 (±2 days)
Handgrip force and knee extension force measured using dynamometry.
Rectus femoris thickness
Time frame: Baseline through postoperative day 14 (±2 days)
Rectus femoris muscle thickness (unit of measurement: mm) assessed by ultrasonography.
5 secondary outcomes
Five-Repetition Sit-to-Stand Test
Time frame: Baseline and hospital discharge
Frailty Status
Time frame: Baseline and at postoperative day 14 (±2 days)
patient-reported symptoms
Time frame: Baseline and at postoperative day 14 (±2 days)
Six-Minute Walk Distance
Time frame: Baseline and at hospital discharge, an average of 3 weeks after surgery.
Anxiety
Time frame: Baseline and at hospital discharge, up to an average of 3 weeks after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Background: PubMed 18444941Maury 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.
- Background: PubMed 26211979Parry 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.
- Background: PubMed 35570300Huh 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.
- Background: PubMed 32362476LoMauro 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.
- Background: PubMed 26701203Kelm 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.
- Background: PubMed 25044057Rozenberg 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.
- Individual participant dataSharing planned: Yes. Participant data that underlie the results reported in this article after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplantation and End Stage Lung Disease, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara K Smith, PhD, PT (352-294-5315, bksmith@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm structure (time frame: Weekly from baseline through postoperative day 14 (±2 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07747337, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.