Clinical trial NCT03457545: Treating Frailty in Lung Transplant Candidates (PREHAB)
Official title: Pilot Study of a Home-based Exercise Intervention to Treat Frailty in Lung Transplant Candidates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Lung Disease
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Testing a home-based intervention to treat frailty in adult lung transplant candidates using a mobile health technology
Primary purpose: OTHER

Brief 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. 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.

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

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.

Eligibility criteria: Inclusion Criteria:

1. Adult lung transplant candidates in the UCSF Lung Transplant Program aged \>=50
2. Ability to understand and speak English or lives with a family member who has the ability to understand and speak English.
3. A diagnosis of chronic obstructive pulmonary disease (COPD) or pulmonary fibrosis (PF).
4. 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)
5. Waitilisted or soon to be waitlisted for lung transplantation at UCSF
6. Short Physical Performance Battery (SPBB) frailty score of 9 or less (range 0 - 12; lower scores = worse frailty).
7. Must be an outpatient.
8. Willing and able to come to UCSF Parnassus Campus for 1 day in-person training program.

Exclusion Criteria:

1. Inability to speak or understand English or does not live with a family member who has the abilty to understand and speak English.
2. Subject does not possess home oxygen equipment (if supplemental oxygen is required for exercise)
3. Already or soon to be enrolled in a traditional hospital based pulmonary rehabilitation program
4. Lives alone.
5. 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.

Primary outcomes:
measure: Subject enrollment
timeFrame: Through study completion, an average of 8 to 12 weeks
measure: Subject attrition
timeFrame: Through study completion, an average of 8 to 12 weeks
measure: Safety
timeFrame: Through study completion, an average of 8 to 12 weeks
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Pre-intervention at week 0 and post-intervention at week 8
measure: Six Minute Walk Distance (6MWD)
timeFrame: Pre-intervention at week 0 and post-intervention at week 8
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Jonathan Singer, MD, MS
role: PRINCIPAL_INVESTIGATOR
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