Lung transplantation is a costly procedure. Estimated costs, from 30 days prior to transplant to 6 months post- surgery, exceed $1 million per patient and routine medical management costs $50,000 per year thereafter. Despite this extensive investment, major challenges remain. Prior to transplant, lung transplant recipients (LTR) self-restrict activity due to severe ventilatory limitation, resulting in reduced muscle mass and qualitative changes in large exercising skeletal muscles. After transplant, despite improved lung function, prior studies consistently report LTR fail to reach predicted physical function or physical activity. Further, nearly 70% of LTR are at risk of developing hypertension within first 5 years due to their immunosuppressive regimen and an inactive lifestyle can worsen this risk. Consequently, full benefits of transplant may not be achieved. Few studies have tested ways to engage LTR to self-manage exercise and adopt an active lifestyle. Initiated by an Early Stage New Investigator, we propose to test Lung Transplant Go (LTGO), a behavioral exercise intervention that provides individualized exercise training integrated with behavioral coaching for LTR in their home. Exercise training will focus on assisting LTR to learn and practice exercises to reverse muscle deconditioning. Behavioral coaching will engage LTR in developing skills to self-manage physical activity in their daily life and maintain this as a sustained habit using strategies that include incremental goal setting, self- monitoring and feedback and problem solving. The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation). Interactive intervention sessions will be delivered to the home via real time video conferencing (10 sessions within 12 weeks); and Phase 2. Transition to self- management. Four telephone sessions (1 behavioral contract + 3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement. Our exciting pilot work successfully demonstrated the feasibility, safety and ability of LTGO to improve physical function and physical activity and was enthusiastically received. We will conduct a two-group randomized controlled trial comparing LTGO against enhanced usual care (EUC). Participants will be 112 LTR randomized to LTGO or EUC (1:1). Outcomes will be measured at baseline, and 3 and 6 months post-randomization. Primary outcomes are physical function (walking ability [6-Minute Walk Test], balance [Berg Balance Scale], lower body strength [30- second Chair-Stand Test], and quadriceps muscle strength [Biodex System 3 Pro]) and physical activity (Actigraph GT3X). Secondary outcome is blood pressure control (preventing onset of hypertension or controlling existing hypertension). Potential mediators will be exercise self-efficacy and self-monitoring (Fitbit Charge HR). Potential moderators will be sex and clinical factors (symptoms, pre- and post-transplant clinical data). Findings will provide evidence regarding efficacy of the LTGO as a means to improve exercise self- management in LTR and, potentially, benefit in individuals living with other complex chronic conditions.

Public Health Relevance

Despite achieving near normal lung function, patients who undergo lung transplantation will not maximally benefit from this life-saving surgery if they continue to self-restrict exercise and physical activity. Goals of this project are to test an innovative telerehabilitation-based behavioral exercise intervention to assist lung transplant patients to improve their capacity to exercise and adopt and maintain an active lifestyle. This intervention has the potential to improve clinical practice related to physical exercise in individuals living with complex chronic conditions or a compromised immune system, hence leading to meaningful improvements in patient health and quality of care.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
5R01NR017196-03
Application #
9901633
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Huss, Karen
Project Start
2018-06-01
Project End
2022-03-31
Budget Start
2020-04-01
Budget End
2021-03-31
Support Year
3
Fiscal Year
2020
Total Cost
Indirect Cost
Name
University of Pittsburgh
Department
Other Health Professions
Type
Schools of Nursing
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15260