Transplant-Related DisorderiFRAILNCT03636412
Improving Frailty With a Rigorous Ambulation Intervention in Lung Transplant Patients
A study testing Ambulation in people with Transplant-Related Disorder and Frail Elderly Syndrome, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The objective of this study is to assess the feasibility and effectiveness of dedicated ambulator-assisted physical activity in lung transplant inpatients. The primary hypothesis is that an ambulator-assisted intervention for lung transplant patients will prove feasible and may result in improved frailty, hospital… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant-Related Disorder, Frail Elderly Syndrome, Sarcopenia
- What is being tested?
- Ambulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2018to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Participant has personally signed and dated informed consent form indicating understanding of all pertinent aspects of the study.
- Speaks fluent English
- Active on the waiting list for a single or bilateral lung transplant
- Able to ambulate pre-transplant (not bed/wheelchair bound) with or without assistive device
- Have undergone a single or bilateral lung transplant
- Admitted to the transplant floor (J82) after discharge from the ICU
- Complete history and physical examination on file
- Physical therapy consult ordered (standard of care) and JH-HLM Scale of greater than or equal to 6 within 72 hours of transfer to the transplant floor
Who cannot join
- Age <18 years
- Admitted to hospital for expedited transplant work-up
- Admitted to hospital prior to date of transplant
- Current invasive mechanical ventilation or placement of ECMO cannula
- Multi-organ transplant patients (liver-lung, heart-lung)
- Bed rest order placed
- Requiring invasive mechanical ventilation during the day/night
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to assess the feasibility and effectiveness of dedicated ambulator-assisted physical activity in lung transplant inpatients. The primary hypothesis is that an ambulator-assisted intervention for lung transplant patients will prove feasible and may result in improved frailty, hospital outcomes, including less need for inpatient rehabilitation and shorter length of stay in the hospital.
Read the detailed description
Lung transplant is a lifesaving intervention for patients with advanced lung disease. In addition to this, patients can experience an improved quality of life and reduction in disability post transplant. Despite extensive candidate evaluation and pre-transplant scoring, waitlist mortality remains relatively high, in 2015 at 16.4 per 100 waitlist years and post-transplant 1-year mortality 16.6%.
Frailty is defined as a "generalized vulnerability to stressors" resulting from an accumulation of cognitive and physiologic deficits, which can lead to a significant decline in health following an additional stressor such, i.e. major surgery. Frailty has been associated with delayed graft function and mortality in kidney transplant recipients and waitlist mortality in liver transplant candidates. Components of frailty include weight loss, exhaustion (self-reported), weakness, slow walking speed and low physical activity, however all these components have a complex interplay.
In lung transplant, frailty was also found to be independently associated with patient-reported disability and with subsequent de-listing or death before transplant. There is conflicting evidence regarding the role of pre-transplant frailty on post-transplant outcomes in regards to overall post-operative mortality and hospital length of stay. However, prospective investigations have shown improvements in frailty following lung transplant can lead to improved disability over the first year following lung transplant.
Physical therapy interventions aimed at elderly, frail non-transplant population, were found to be successful at reducing future frailty and mobility related disability. Important components of these regimens include resistance and endurance building exercises to improve maximum oxygen consumption and muscular strength. Identifying at-risk candidates pre- and post-transplant may allow for interventions to improve outcomes. It may also assist in preventing re-admissions, since previous investigations have shown frailty was associated with 30-day hospital re-admissions in patients with after colorectal surgery.
Post-transplant, standard care should include physical activity for patients to help prevent post-operative atelectasis, increase energy, fuel appetite and reduce frailty. In lung transplant patients, exercise following transplantation has been shown to beneficial for muscular strength, six-minute walk distance and self-reported physical functioning. However the reality of care is that physical therapy availability may limit patients from ambulating more than once daily while hospitalized. An improvement in the level of activity available to patients is critical to daily their daily progress after transplant.
The investigators hypothesize that a graded protocol of ambulation which can be implemented by a dedicated patient care nursing assistant (PCNA) multiple times daily will provide significant benefit to patients without the labor and cost requirements of full-time nursing and physical therapy expertise.
The investigators believe this intervention will improve frailty in participants. These benefits will be objectively measured with evaluation of frailty during the pre- and post-transplant period, along with documentation of hospital length of stay, discharge disposition, overall mortality, 30-day readmission rate, and the number of inpatient falls.
- Conditions
- Transplant-Related Disorder, Frail Elderly Syndrome, Sarcopenia, Lung Graft Dysfunction, Mobility Limitation
- Being tested
- Ambulation
- Keywords
- lung transplant, frailty
- Medical subject headings
- Sarcopenia, Mobility Limitation, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmbulationOther
An ambulator will walk with a patient three times a day, based on physical therapy recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory Intervention | Experimental | Patients who score greater than or equal to 6 on the John's Hopkins Highest Level of Mobility (JH-HLM) scale, up to 72 hours after transfer from the ICU to the regular nursing floor will be enrolled in an ambulatory intervention. Care technicians will ambulate patients three times per day at their level of physical ability. They will also receive physical therapy standard of care. Receives: Other: Ambulation |
| No Ambulator | No intervention | Patients who score less than 6 on the John's Hopkins Highest Level of Mobility (JH-HLM) scale, up to 72 hours after transfer from the ICU to the regular nursing floor will not be enrolled in the ambulatory intervention. They will receive physical therapy standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
The duration of time in days for the index admission for the patient beginning immediately after lung transplant
Measured: Through study completion, approximately 1 year post-transplant
Regular Nursing Floor Length of Stay
The duration of time in days a patient stayed on the regular nursing floor following lung transplant
Measured: Through study completion, approximately 1 year post-transplant
30-day readmission
The incidence of readmission to hospital within 30 days of patient discharge from hospital after index lung transplant admission
Measured: Up to 30 days following discharge
Secondary outcomes (16)
Change in physical frailty phenotype
Change in physical frailty phenotype pre and post-transplant
Measured: pre-transplant to 1 year following transplant
Change in short physical performance battery
Change in short physical performance battery pre and post-transplant
Measured: pre-transplant to 1 year following transplant
Change in AMPAC/6-click score
Change in AMPAC/6-click score pre and post-transplant
Measured: pre-transplant to 1 year following transplant
Change in sarcopenia
Change in sarcopenia pre and post-transplant (m2)
Measured: pre-transplant to 1 year following transplant
Change in nutritional status; serum albumin
Change in nutritional status; serum albumin pre and post-transplant (g/dL)
Measured: pre-transplant to 1 year following transplant
Change in nutritional status; serum protein
Change in nutritional status; serum protein pre and post-transplant (g/dL)
Measured: pre-transplant to 1 year following transplant
Change in nutritional status; BMI
Change in nutritional status; BMI pre and post-transplant (kg/m2)
Measured: pre-transplant to 1 year following transplant
Change in eyeball frailty assessment
Change in eyeball frailty assessment pre and post-transplant
Measured: pre-transplant to 1 year following transplant
Presence of aspiration
Presence of aspiration pre and post-transplant
Measured: pre-transplant to 1 year following transplant
Readmission to ICU
Readmission to ICU during index hospitalization for lung transplant
Measured: Through study completion, approximately 1 year post-transplant
In-hospital falls
Clinical documentation of a fall during index hospital admission for lung transplant
Measured: Through study completion, approximately 1 year post-transplant
Aspiration event
Presence of clinical aspiration event during index hospital admission for lung transplant
Measured: Through study completion, approximately 1 year post-transplant
Graft survival
Duration of graft functioning from transplant until patient death or re-transplantation
Measured: Through study completion, approximately 1 year post-transplant
Accelerometer step change
Change in steps from pre-transplant to post-transplant
Measured: pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant
Accelerometer energy expenditure
Change in energy expenditure from pre-transplant to post-transplant
Measured: pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant
Accelerometer time ambulating
Change in time ambulating from pre-transplant to post-transplant
Measured: pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start15 Aug 2018
- Primary completion15 Apr 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Transplant-Related DisorderStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be recruited pre-transplant but on re-evaluation post-transplant based on mobility post-transplant will be enrolled in the ambulatory intervention.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Budev, DO, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636412
- Sponsor's protocol ID
- 18-529
- Acronym
- iFRAIL
- Status last verified
- May 2025
- First submitted
- 13 Aug 2018
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singer JP, Singer LG. Quality of life in lung transplantation. Semin Respir Crit Care Med. 2013 Jun;34(3):421-30. doi: 10.1055/s-0033-1348470. Epub 2013 Jul 2.
PubMed 23821515Valapour M, Skeans MA, Heubner BM, Smith JM, Schnitzler MA, Hertz MI, Edwards LB, Snyder JJ, Israni AK, Kasiske BL. OPTN/SRTR 2012 Annual Data Report: lung. Am J Transplant. 2014 Jan;14 Suppl 1:139-65. doi: 10.1111/ajt.12584.
PubMed 24373171Yusen RD, Edwards LB, Kucheryavaya AY, Benden C, Dipchand AI, Dobbels F, Goldfarb SB, Levvey BJ, Lund LH, Meiser B, Stehlik J; International Society for Heart and Lung Transplantation. The registry of the International Society for Heart and Lung Transplantation: thirty-first adult lung and heart-lung transplant report--2014; focus theme: retransplantation. J Heart Lung Transplant. 2014 Oct;33(10):1009-24. doi: 10.1016/j.healun.2014.08.004. Epub 2014 Aug 14. No abstract available.
PubMed 25242125Valapour M, Skeans MA, Smith JM, Edwards LB, Cherikh WS, Uccellini K, Israni AK, Snyder JJ, Kasiske BL. OPTN/SRTR 2015 Annual Data Report: Lung. Am J Transplant. 2017 Jan;17 Suppl 1:357-424. doi: 10.1111/ajt.14129.
PubMed 28052607Singer JP, Diamond JM, Gries CJ, McDonnough J, Blanc PD, Shah R, Dean MY, Hersh B, Wolters PJ, Tokman S, Arcasoy SM, Ramphal K, Greenland JR, Smith N, Heffernan P, Shah L, Shrestha P, Golden JA, Blumenthal NP, Huang D, Sonett J, Hays S, Oyster M, Katz PP, Robbins H, Brown M, Leard LE, Kukreja J, Bacchetta M, Bush E, D'Ovidio F, Rushefski M, Raza K, Christie JD, Lederer DJ. Frailty Phenotypes, Disability, and Outcomes in Adult Candidates for Lung Transplantation. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1325-34. doi: 10.1164/rccm.201506-1150OC.
PubMed 26258797Garonzik-Wang JM, Govindan P, Grinnan JW, Liu M, Ali HM, Chakraborty A, Jain V, Ros RL, James NT, Kucirka LM, Hall EC, Berger JC, Montgomery RA, Desai NM, Dagher NN, Sonnenday CJ, Englesbe MJ, Makary MA, Walston JD, Segev DL. Frailty and delayed graft function in kidney transplant recipients. Arch Surg. 2012 Feb;147(2):190-3. doi: 10.1001/archsurg.2011.1229.
PubMed 22351919McAdams-DeMarco MA, Law A, King E, Orandi B, Salter M, Gupta N, Chow E, Alachkar N, Desai N, Varadhan R, Walston J, Segev DL. Frailty and mortality in kidney transplant recipients. Am J Transplant. 2015 Jan;15(1):149-54. doi: 10.1111/ajt.12992. Epub 2014 Oct 30.
PubMed 25359393Lai JC, Feng S, Terrault NA, Lizaola B, Hayssen H, Covinsky K. Frailty predicts waitlist mortality in liver transplant candidates. Am J Transplant. 2014 Aug;14(8):1870-9. doi: 10.1111/ajt.12762. Epub 2014 Jun 16.
PubMed 24935609Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Wilson ME, Vakil AP, Kandel P, Undavalli C, Dunlay SM, Kennedy CC. Pretransplant frailty is associated with decreased survival after lung transplantation. J Heart Lung Transplant. 2016 Feb;35(2):173-8. doi: 10.1016/j.healun.2015.10.014. Epub 2015 Oct 19.
PubMed 26679297Singer JP, Lederer DJ, Baldwin MR. Frailty in Pulmonary and Critical Care Medicine. Ann Am Thorac Soc. 2016 Aug;13(8):1394-404. doi: 10.1513/AnnalsATS.201512-833FR.
PubMed 27104873Singer JP, Peterson ER, Snyder ME, Katz PP, Golden JA, D'Ovidio F, Bacchetta M, Sonett JR, Kukreja J, Shah L, Robbins H, Van Horn K, Shah RJ, Diamond JM, Wickersham N, Sun L, Hays S, Arcasoy SM, Palmer SM, Ware LB, Christie JD, Lederer DJ. Body composition and mortality after adult lung transplantation in the United States. Am J Respir Crit Care Med. 2014 Nov 1;190(9):1012-21. doi: 10.1164/rccm.201405-0973OC.
PubMed 25233138Jones SE, Maddocks M, Kon SS, Canavan JL, Nolan CM, Clark AL, Polkey MI, Man WD. Sarcopenia in COPD: prevalence, clinical correlates and response to pulmonary rehabilitation. Thorax. 2015 Mar;70(3):213-8. doi: 10.1136/thoraxjnl-2014-206440. Epub 2015 Jan 5.
PubMed 25561517Kelm 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 26701203Cameron ID, Fairhall N, Langron C, Lockwood K, Monaghan N, Aggar C, Sherrington C, Lord SR, Kurrle SE. A multifactorial interdisciplinary intervention reduces frailty in older people: randomized trial. BMC Med. 2013 Mar 11;11:65. doi: 10.1186/1741-7015-11-65.
PubMed 23497404
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Frailty With a Rigorous Ambulation Intervention in Lung Transplant Patients
- ClinicalTrials.gov ID
- NCT03636412
- Acronym / sponsor ID
- iFRAIL / 18-529
- Conditions
- Transplant-Related Disorder, Frail Elderly Syndrome, Sarcopenia, Lung Graft Dysfunction, Mobility Limitation
- Keywords
- lung transplant, frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 17 Aug 2018 (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 objective of this study is to assess the feasibility and effectiveness of dedicated ambulator-assisted physical activity in lung transplant inpatients. The primary hypothesis is that an ambulator-assisted intervention for lung transplant patients will prove feasible and may result in improved frailty, hospital outcomes, including less need for inpatient rehabilitation and shorter length of stay in the hospital.
Detailed description
Lung transplant is a lifesaving intervention for patients with advanced lung disease. In addition to this, patients can experience an improved quality of life and reduction in disability post transplant. Despite extensive candidate evaluation and pre-transplant scoring, waitlist mortality remains relatively high, in 2015 at 16.4 per 100 waitlist years and post-transplant 1-year mortality 16.6%.
Frailty is defined as a "generalized vulnerability to stressors" resulting from an accumulation of cognitive and physiologic deficits, which can lead to a significant decline in health following an additional stressor such, i.e. major surgery. Frailty has been associated with delayed graft function and mortality in kidney transplant recipients and waitlist mortality in liver transplant candidates. Components of frailty include weight loss, exhaustion (self-reported), weakness, slow walking speed and low physical activity, however all these components have a complex interplay.
In lung transplant, frailty was also found to be independently associated with patient-reported disability and with subsequent de-listing or death before transplant. There is conflicting evidence regarding the role of pre-transplant frailty on post-transplant outcomes in regards to overall post-operative mortality and hospital length of stay. However, prospective investigations have shown improvements in frailty following lung transplant can lead to improved disability over the first year following lung transplant.
Physical therapy interventions aimed at elderly, frail non-transplant population, were found to be successful at reducing future frailty and mobility related disability. Important components of these regimens include resistance and endurance building exercises to improve maximum oxygen consumption and muscular strength. Identifying at-risk candidates pre- and post-transplant may allow for interventions to improve outcomes. It may also assist in preventing re-admissions, since previous investigations have shown frailty was associated with 30-day hospital re-admissions in patients with after colorectal surgery.
Post-transplant, standard care should include physical activity for patients to help prevent post-operative atelectasis, increase energy, fuel appetite and reduce frailty. In lung transplant patients, exercise following transplantation has been shown to beneficial for muscular strength, six-minute walk distance and self-reported physical functioning. However the reality of care is that physical therapy availability may limit patients from ambulating more than once daily while hospitalized. An improvement in the level of activity available to patients is critical to daily their daily progress after transplant.
The investigators hypothesize that a graded protocol of ambulation which can be implemented by a dedicated patient care nursing assistant (PCNA) multiple times daily will provide significant benefit to patients without the labor and cost requirements of full-time nursing and physical therapy expertise.
The investigators believe this intervention will improve frailty in participants. These benefits will be objectively measured with evaluation of frailty during the pre- and post-transplant period, along with documentation of hospital length of stay, discharge disposition, overall mortality, 30-day readmission rate, and the number of inpatient falls.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be recruited pre-transplant but on re-evaluation post-transplant based on mobility post-transplant will be enrolled in the ambulatory intervention.
| Arm | Type | Receives |
|---|---|---|
| Ambulatory Intervention | Experimental | Other: AmbulationPatients who score greater than or equal to 6 on the John's Hopkins Highest Level of Mobility (JH-HLM) scale, up to 72 hours after transfer from the ICU to the regular nursing floor will be enrolled in an ambulatory intervention. Care technicians will ambulate patients three times per day at their level of physical ability. They will also receive physical therapy standard of care. |
| No Ambulator | No intervention | –Patients who score less than 6 on the John's Hopkins Highest Level of Mobility (JH-HLM) scale, up to 72 hours after transfer from the ICU to the regular nursing floor will not be enrolled in the ambulatory intervention. They will receive physical therapy standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant has personally signed and dated informed consent form indicating understanding of all pertinent aspects of the study.
- Speaks fluent English
- Active on the waiting list for a single or bilateral lung transplant
- Able to ambulate pre-transplant (not bed/wheelchair bound) with or without assistive device
- Have undergone a single or bilateral lung transplant
Key exclusion criteria (7 listed)
- Age <18 years
- Admitted to hospital for expedited transplant work-up
- Admitted to hospital prior to date of transplant
- Current invasive mechanical ventilation or placement of ECMO cannula
- Multi-organ transplant patients (liver-lung, heart-lung)
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 |
|---|---|---|
| AmbulationAn ambulator will walk with a patient three times a day, based on physical therapy recommendations. | Other | Ambulatory Intervention |
Primary outcome
Hospital Length of Stay
Time frame: Through study completion, approximately 1 year post-transplant
The duration of time in days for the index admission for the patient beginning immediately after lung transplant
Regular Nursing Floor Length of Stay
Time frame: Through study completion, approximately 1 year post-transplant
The duration of time in days a patient stayed on the regular nursing floor following lung transplant
30-day readmission
Time frame: Up to 30 days following discharge
The incidence of readmission to hospital within 30 days of patient discharge from hospital after index lung transplant admission
16 secondary outcomes
Change in physical frailty phenotype
Time frame: pre-transplant to 1 year following transplant
Change in short physical performance battery
Time frame: pre-transplant to 1 year following transplant
Change in AMPAC/6-click score
Time frame: pre-transplant to 1 year following transplant
Change in sarcopenia
Time frame: pre-transplant to 1 year following transplant
Change in nutritional status; serum albumin
Time frame: pre-transplant to 1 year following transplant
Change in nutritional status; serum protein
Time frame: pre-transplant to 1 year following transplant
Change in nutritional status; BMI
Time frame: pre-transplant to 1 year following transplant
Change in eyeball frailty assessment
Time frame: pre-transplant to 1 year following transplant
Presence of aspiration
Time frame: pre-transplant to 1 year following transplant
Readmission to ICU
Time frame: Through study completion, approximately 1 year post-transplant
In-hospital falls
Time frame: Through study completion, approximately 1 year post-transplant
Aspiration event
Time frame: Through study completion, approximately 1 year post-transplant
Graft survival
Time frame: Through study completion, approximately 1 year post-transplant
Accelerometer step change
Time frame: pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant
Accelerometer energy expenditure
Time frame: pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant
Accelerometer time ambulating
Time frame: pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Background: PubMed 23821515Singer JP, Singer LG. Quality of life in lung transplantation. Semin Respir Crit Care Med. 2013 Jun;34(3):421-30. doi: 10.1055/s-0033-1348470. Epub 2013 Jul 2.
- Background: PubMed 24373171Valapour M, Skeans MA, Heubner BM, Smith JM, Schnitzler MA, Hertz MI, Edwards LB, Snyder JJ, Israni AK, Kasiske BL. OPTN/SRTR 2012 Annual Data Report: lung. Am J Transplant. 2014 Jan;14 Suppl 1:139-65. doi: 10.1111/ajt.12584.
- Background: PubMed 25242125Yusen RD, Edwards LB, Kucheryavaya AY, Benden C, Dipchand AI, Dobbels F, Goldfarb SB, Levvey BJ, Lund LH, Meiser B, Stehlik J; International Society for Heart and Lung Transplantation. The registry of the International Society for Heart and Lung Transplantation: thirty-first adult lung and heart-lung transplant report--2014; focus theme: retransplantation. J Heart Lung Transplant. 2014 Oct;33(10):1009-24. doi: 10.1016/j.healun.2014.08.004. Epub 2014 Aug 14. No abstract available.
- Background: PubMed 28052607Valapour M, Skeans MA, Smith JM, Edwards LB, Cherikh WS, Uccellini K, Israni AK, Snyder JJ, Kasiske BL. OPTN/SRTR 2015 Annual Data Report: Lung. Am J Transplant. 2017 Jan;17 Suppl 1:357-424. doi: 10.1111/ajt.14129.
- Background: PubMed 26258797Singer JP, Diamond JM, Gries CJ, McDonnough J, Blanc PD, Shah R, Dean MY, Hersh B, Wolters PJ, Tokman S, Arcasoy SM, Ramphal K, Greenland JR, Smith N, Heffernan P, Shah L, Shrestha P, Golden JA, Blumenthal NP, Huang D, Sonett J, Hays S, Oyster M, Katz PP, Robbins H, Brown M, Leard LE, Kukreja J, Bacchetta M, Bush E, D'Ovidio F, Rushefski M, Raza K, Christie JD, Lederer DJ. Frailty Phenotypes, Disability, and Outcomes in Adult Candidates for Lung Transplantation. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1325-34. doi: 10.1164/rccm.201506-1150OC.
- Background: PubMed 22351919Garonzik-Wang JM, Govindan P, Grinnan JW, Liu M, Ali HM, Chakraborty A, Jain V, Ros RL, James NT, Kucirka LM, Hall EC, Berger JC, Montgomery RA, Desai NM, Dagher NN, Sonnenday CJ, Englesbe MJ, Makary MA, Walston JD, Segev DL. Frailty and delayed graft function in kidney transplant recipients. Arch Surg. 2012 Feb;147(2):190-3. doi: 10.1001/archsurg.2011.1229.
- Background: PubMed 25359393McAdams-DeMarco MA, Law A, King E, Orandi B, Salter M, Gupta N, Chow E, Alachkar N, Desai N, Varadhan R, Walston J, Segev DL. Frailty and mortality in kidney transplant recipients. Am J Transplant. 2015 Jan;15(1):149-54. doi: 10.1111/ajt.12992. Epub 2014 Oct 30.
- Background: PubMed 24935609Lai JC, Feng S, Terrault NA, Lizaola B, Hayssen H, Covinsky K. Frailty predicts waitlist mortality in liver transplant candidates. Am J Transplant. 2014 Aug;14(8):1870-9. doi: 10.1111/ajt.12762. Epub 2014 Jun 16.
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Background: PubMed 26679297Wilson ME, Vakil AP, Kandel P, Undavalli C, Dunlay SM, Kennedy CC. Pretransplant frailty is associated with decreased survival after lung transplantation. J Heart Lung Transplant. 2016 Feb;35(2):173-8. doi: 10.1016/j.healun.2015.10.014. Epub 2015 Oct 19.
- Background: PubMed 27104873Singer JP, Lederer DJ, Baldwin MR. Frailty in Pulmonary and Critical Care Medicine. Ann Am Thorac Soc. 2016 Aug;13(8):1394-404. doi: 10.1513/AnnalsATS.201512-833FR.
- Background: PubMed 25233138Singer JP, Peterson ER, Snyder ME, Katz PP, Golden JA, D'Ovidio F, Bacchetta M, Sonett JR, Kukreja J, Shah L, Robbins H, Van Horn K, Shah RJ, Diamond JM, Wickersham N, Sun L, Hays S, Arcasoy SM, Palmer SM, Ware LB, Christie JD, Lederer DJ. Body composition and mortality after adult lung transplantation in the United States. Am J Respir Crit Care Med. 2014 Nov 1;190(9):1012-21. doi: 10.1164/rccm.201405-0973OC.
- Individual participant dataSharing planned: No
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Not yet recruitingPhase 1
Clonal Fetal Mesenchymal Stem Cells (cfMSCs) for the Control of Immune-related Disorders
Immune Related Disorder, Tissue Damage
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Not yet recruiting
Investigation of the Gut-Brain Axis in Alcohol Use Disorder
Alcohol Use Disorder (AUD), Alcohol Abstinence
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. This study is not recruiting at the moment.
Marie Budev, DO principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulation in people with Transplant-Related Disorder and Frail Elderly Syndrome, run by The Cleveland Clinic 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 14 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Length of Stay (time frame: Through study completion, approximately 1 year post-transplant). The study lists 3 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 NCT03636412, which also lists 20 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 14 May 2025.