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Advanced Lung DiseasePREHABNCT03457545

Treating Frailty in Lung Transplant Candidates (PREHAB)

A study testing Home-based pulmonary rehabilitation and Aidcube in people with Advanced Lung Disease, run by University of California, San Francisco.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this pilot project, 35 lung transplant candidates will be recruited to participate in a three month individualized home-based program focused on exercise and nutrition optimization. This pilot is designed to assess the feasibility of treating frailty before lung transplantation. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Advanced Lung Disease
What is being tested?
Home-based pulmonary rehabilitation and Aidcube
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
No sites listed yet
Study dates
11 Dec 2015to 14 Dec 2017
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult lung transplant candidates in the UCSF Lung Transplant Program aged >=50
  • Ability to understand and speak English or lives with a family member who has the ability to understand and speak English.
  • A diagnosis of chronic obstructive pulmonary disease (COPD) or pulmonary fibrosis (PF).
  • A supplemental oxygen requirement with exercise that can be delivered safely at home using their home oxygen concentrator (as determined by clinically available six-minute walk distance test)
  • Waitilisted or soon to be waitlisted for lung transplantation at UCSF
  • Short Physical Performance Battery (SPBB) frailty score of 9 or less (range 0 - 12; lower scores = worse frailty).
  • Must be an outpatient.
  • Willing and able to come to UCSF Parnassus Campus for 1 day in-person training program.

Who cannot join

  • Inability to speak or understand English or does not live with a family member who has the abilty to understand and speak English.
  • Subject does not possess home oxygen equipment (if supplemental oxygen is required for exercise)
  • Already or soon to be enrolled in a traditional hospital based pulmonary rehabilitation program
  • Lives alone.
  • A diagnosis of primary or secondary pulmonary hypertension. Diagnosis will be determined by clinically available right heart catheterization pulmonary arterial mean pressure >= 30 mm Hg or transthoracic echocardiogram pulmonary arterial systolic pressure > 50 mm Hg or report of moderate right ventricular dysfunction or worse. These tests are performed as part of routine clinical care in the lung transplant program. Echocardiograms are repeated every 6 months while patients are listed for transplantation.

About this study

Official title: Pilot Study of a Home-based Exercise Intervention to Treat Frailty in Lung Transplant Candidates

In this pilot project, 35 lung transplant candidates will be recruited to participate in a three month individualized home-based program focused on exercise and nutrition optimization. This pilot is designed to assess the feasibility of treating frailty before lung transplantation. Participants will complete a 1 day in-person assessment and training session that will include baseline frailty assessment, determination of exercise capacity, and a determination of nutritional status. Based on American Thoracic Society Guidelines and a diet evaluation by a registered dietician, information gathered during the assessment will be used to develop a tailored prescription for exercise and nutrition to be continued at home. Participants will also be taught self-management skills specific to control of dyspnea, fatigue, motivation, and support. Participants will receive training in protocol implementation at home by a coordinator trained in principles of behavior change, adult learning theory, and dyspnea control techniques. Subjects will be provided tablet computers with an app called Aidcube preloaded and taught how to interface with the app. Aidcube is a commercially available exercise platform designed for patients with lung and heart diseases. It was designed with the input of physicians, physical therapists, respiratory therapists, nutritionists who specialize in patients with lung and heart disease and adheres to professional society guidelines for exercise and rehabilitation in patients with lung disease. Subjects will then adhere to a individually tailored home exercise and nutrition program based on their exercise capacity. Aidcube allows clinicians (or in this case the PI and co-PI) the ability to design a customized program of exercises and diet plan through the "provider interface". The subjects interacts with the "patient interface" to complete their exercise program during the 8 week study intervention.

This goal of this pilot project is to determine the feasibility of implementing a home-based exercise and nutrition program with patients with advanced lung disease awaiting lung transplantation.

Read more

Information on Aidcube can be found at https://www.aidcube.com.

The overarching aim of this pilot study is preparatory investigation to evaluate the feasibility of performing a home-based intervention to treat frailty in lung transplant candidates.

Specific aims:

  • Establish a sampling time frame and recruitment techniques.
  • Assess willingness to participate
  • Assess adherence and compliance.
  • Identify logistical problems in the in-person and at-home components of the intervention
  • Determine the resources needed for a full-scale study.
  • Provide funding bodies evidence that research team is competent and knowledgeable.
  • Provide funding bodies that the study is feasible
Read the detailed description

Lung transplantation aims to extend survival, reduce disability, and improve health-related quality of life for persons suffering from advanced lung diseases. Despite rigorous candidacy screening practices, improvements in surgical and medical management, and iterative advancements in organ allocation policies, nearly 20% of adults awaiting lung transplantation die or are removed from the waiting list due to disease progression prior to receiving a suitable donor offer1. After lung transplantation, nearly the same proportion of patients dies within the first post-operative year2. Notably, serious morbidity after transplantation is increasing, with resultant disability and associated decrements in health-related quality of life3,4. Although known risk factors for death are already incorporated into lung allocation in the United States (Lung Allocation Score [LAS]), persistently high mortality and increasing morbidity underscore the need to identify novel risk factors for poor outcomes in order to maximize the individual and societal benefit of lung transplantation5.

Frailty- measured by simple, non-invasive clinic based instruments- is an independent risk factor for disability, perioperative complications, and mortality in older medical6-9 and surgical populations10-13. Conceptualized first in the field of geriatrics, frailty is defined as a generalized vulnerability to stressors resulting from an accumulation of physiologic deficits across multiple interrelated systems14. These deficits, in turn, deplete the body's physiologic reserves, resulting in a "state-of-risk" for disproportionate declines in health status following exposure to an additional stressor such as major surgery. Drawing from the geriatrics experience, frailty has become recognized more recently as a risk factor for poor outcomes in solid organ transplantation. Specifically, frailty has been found to be associated with delayed graft function and mortality in kidney transplant recipients and waitlist mortality in liver transplant candidates15-17.

The evaluation of geriatric derived measures is particularly important in contemporary lung transplantation. Indeed, older patients are the fastest growing group of lung transplant candidates in the U.S18. Compared to 8% in 2004, patients aged 65 now account for 30% of annual new recipients, outnumbering those aged 50; those aged 60 account for over half of all new transplants19. This rapid trend has outpaced the evidence base, risk stratification tools, and society guidelines needed to identify which older candidates will do well after lung transplantation. Absent better information, transplant programs have resorted to either ad hoc and admittedly arbitrary chronological age cutoffs or "eyeball tests" of fitness for transplant.

The investigators recently identified frailty as prevalent in lung transplant candidates and independently associated with delisting or death on the waitlist18. Very recently, studies in other populations suggest frailty may be reversible through targeted exercise and nutrition programs. While pulmonary rehabilitation programs may achieve similar goals, a substantial proportion of patients cannot access these programs due to geography or insurance limitations. The investigator's overarching hypothesis is that treating frailty with a home-based intervention before transplant may 1) reduce the risk of death or delisting for becoming too debilitated before transplant and 2) may reduce complications, disability, and possibly mortality after lung transplantation. This proposal seeks to generate critical pilot data needed to inform a larger intervention to treat frailty in lung transplant candidates.

Being tested
Home-based pulmonary rehabilitation, Aidcube

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-based pulmonary rehabilitationBehavioural

    Pilot study of a home-based pulmonary rehabilitation study for lung transplant candidates at the University of California San Francisco

  • AidcubeOther

    Participants will be testing and giving feedback on the use of the Aidcube platform in being able to deliver their home-exercise prescription

Study groups in NCT03457545
Study groupRoleWhat they receive
InterventionExperimentalEligible participants will take part in the home-based pulmonary rehabilitation using the Aidcube platform in-person assessment and training with a research coordinator (i.e. physical exercise capacity assessment, SPPB, disability survey, exercise prescription determination, exercise training, dyspnea control techniques) and complete an follow-up assessment at the 8th week.
Receives: Behavioral: Home-based pulmonary rehabilitation; Other: Aidcube
No InterventionNo interventionIneligible participants will receive standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subject enrollment

    Target patients who do not have access to traditional pulmonary rehabilitation programs

    Measured: Through study completion, an average of 8 to 12 weeks

  2. Subject attrition

    Participant ability to complete program before receiving a lung transplant

    Measured: Through study completion, an average of 8 to 12 weeks

  3. Safety

    Record number of adverse events, specifically (1) extreme breathlessness, fatigue, and/or weakness, (2) chest pain, (3) severe muscle pain, (4) dizziness or feeling faint, (5) leg pain, weakness or cramping, (6) sweating more than usual, (7) increase in mucus production, and (8) oxygen saturation levels falling below 85% during exercise

    Measured: Through study completion, an average of 8 to 12 weeks

Secondary outcomes (2)

  1. Short Physical Performance Battery (SPPB)

    Change in SPPB score (MCID = 1 point)

    Measured: Pre-intervention at week 0 and post-intervention at week 8

  2. Six Minute Walk Distance (6MWD)

    Change in 6MWD (MCID = 30 meters

    Measured: Pre-intervention at week 0 and post-intervention at week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2018
  2. Study start11 Dec 2015
  3. Primary completion14 Dec 2017
  4. Study completion14 Dec 2017

Resources

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
Other
Allocation
Non-randomised
Intervention model
Single group
Model description
Testing a home-based intervention to treat frailty in adult lung transplant candidates using a mobile health technology
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03457545
Sponsor's protocol ID
15-17503
Acronym
PREHAB
Status last verified
Mar 2024
First submitted
20 Feb 2018
Last updated
7 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Valapour 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 24373171

  • Yusen 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 25242125

  • Maxwell BG, Mooney JJ, Lee PH, Levitt JE, Chhatwani L, Nicolls MR, Zamora MR, Valentine V, Weill D, Dhillon GS. Increased resource use in lung transplant admissions in the lung allocation score era. Am J Respir Crit Care Med. 2015 Feb 1;191(3):302-8. doi: 10.1164/rccm.201408-1562OC.

    PubMed 25517213

  • Lyu DM, Zamora MR. Medical complications of lung transplantation. Proc Am Thorac Soc. 2009 Jan 15;6(1):101-7. doi: 10.1513/pats.200808-077GO.

    PubMed 19131535

  • Egan TM, Murray S, Bustami RT, Shearon TH, McCullough KP, Edwards LB, Coke MA, Garrity ER, Sweet SC, Heiney DA, Grover FL. Development of the new lung allocation system in the United States. Am J Transplant. 2006;6(5 Pt 2):1212-27. doi: 10.1111/j.1600-6143.2006.01276.x.

    PubMed 16613597

  • Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med. 1995 Mar 2;332(9):556-61. doi: 10.1056/NEJM199503023320902.

    PubMed 7838189

  • Newman AB, Gottdiener JS, Mcburnie MA, Hirsch CH, Kop WJ, Tracy R, Walston JD, Fried LP; Cardiovascular Health Study Research Group. Associations of subclinical cardiovascular disease with frailty. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M158-66. doi: 10.1093/gerona/56.3.m158.

    PubMed 11253157

  • Sancarlo D, Pilotto A, Panza F, Copetti M, Longo MG, D'Ambrosio P, D'Onofrio G, Ferrucci L, Pilotto A. A Multidimensional Prognostic Index (MPI) based on a comprehensive geriatric assessment predicts short- and long-term all-cause mortality in older hospitalized patients with transient ischemic attack. J Neurol. 2012 Apr;259(4):670-8. doi: 10.1007/s00415-011-6241-4. Epub 2011 Sep 23.

    PubMed 21947223

  • Kristjansson SR, Nesbakken A, Jordhoy MS, Skovlund E, Audisio RA, Johannessen HO, Bakka A, Wyller TB. Comprehensive geriatric assessment can predict complications in elderly patients after elective surgery for colorectal cancer: a prospective observational cohort study. Crit Rev Oncol Hematol. 2010 Dec;76(3):208-17. doi: 10.1016/j.critrevonc.2009.11.002. Epub 2009 Dec 14.

    PubMed 20005123

  • Lee DH, Buth KJ, Martin BJ, Yip AM, Hirsch GM. Frail patients are at increased risk for mortality and prolonged institutional care after cardiac surgery. Circulation. 2010 Mar 2;121(8):973-8. doi: 10.1161/CIRCULATIONAHA.108.841437. Epub 2010 Feb 16.

    PubMed 20159833

  • Lee JS, He K, Harbaugh CM, Schaubel DE, Sonnenday CJ, Wang SC, Englesbe MJ, Eliason JL; Michigan Analytic Morphomics Group (MAMG). Frailty, core muscle size, and mortality in patients undergoing open abdominal aortic aneurysm repair. J Vasc Surg. 2011 Apr;53(4):912-7. doi: 10.1016/j.jvs.2010.10.111. Epub 2011 Jan 7.

    PubMed 21215580

  • Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.

    PubMed 20510798

  • Fried 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 11253156

  • Garonzik-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 22351919

  • Lai 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 24935609

Questions about this trial

What is this clinical trial studying?

A study testing Home-based pulmonary rehabilitation and Aidcube in people with Advanced Lung Disease, run by University of California, San Francisco.

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 5 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 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Subject enrollment (time frame: Through study completion, an average of 8 to 12 weeks). 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 NCT03457545, which also lists 23 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 7 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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