Design of Lung Transplant Go (LTGO): A randomized controlled trial evaluating the efficacy of a telerehabilitation behavioral exercise intervention to improve physical activity, physical function, and blood pressure control after lung transplantation

Melissa L Vendetti; Seol Ju Esther Moon; Christopher C Imes; Andrea Hergenroeder; Frank Sciurba; Elizabeth Lendermon; Joseph Pilewski; Dianxu Ren; Bambang Parmanto; Barbara Dewhirst; Bryan Willey; Kristen Jones; Matthew R Morrell; Pablo Sanchez; Annette DeVito Dabbs

doi:10.1016/j.conctc.2023.101097

Design of Lung Transplant Go (LTGO): A randomized controlled trial evaluating the efficacy of a telerehabilitation behavioral exercise intervention to improve physical activity, physical function, and blood pressure control after lung transplantation

Contemp Clin Trials Commun. 2023 Feb 28:33:101097. doi: 10.1016/j.conctc.2023.101097. eCollection 2023 Jun.

Authors

Affiliations

¹ University of Pittsburgh, School of Nursing, Department of Acute and Tertiary Care, Pittsburgh, PA, USA.
² University of Pittsburgh, School of Health and Rehabilitation Sciences, Department of Physical Therapy, Pittsburgh, PA, USA.
³ University of Pittsburgh, School of Medicine, Department of Medicine, Division of Pulmonary Allergy Critical Care Medicine, Pittsburgh, PA, USA.
⁴ University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, USA.
⁵ University of Pittsburgh, School of Health and Rehabilitation Sciences, Department of Health Information Management, Pittsburgh, PA, USA.
⁶ University of Utah Health, Internal Medicine, Division of Pulmonary and Critical Care, Salt Lake City, UT, USA.
⁷ University of Pittsburgh, School of Medicine, Department of Surgery, Division of Cardiothoracic Surgery, Pittsburgh, PA, USA.

Abstract

Background: Lung transplantation is an established treatment option for persons with advanced lung disease. After transplantation, lung function typically returns to near normal levels, however exercise capacity remains low due to chronic deconditioning, limited physical function, and inactive lifestyles which undermine the intended benefits of the highly selective, resource-intensive transplant procedure. Pulmonary rehabilitation is recommended to improve fitness and activity tolerance, however due to multiple barriers, lung transplant recipients either never participate, or fail to complete, pulmonary rehabilitation programs.

Purpose: To describe the design of Lung Transplant Go (LTGO), a trial modified for the remote environment based on recommendations to preserve trial integrity during COVID. The aims are to evaluate a behavioral exercise intervention to improve physical function, physical activity, and blood pressure control in lung transplant recipients conducted safely and effectively using a telerehabilitation (telerehab) platform, and to explore the role of potential mediators and moderators of the relationship between LTGO and outcomes.

Methods: Single-site, 2-group randomized controlled trial with lung transplant recipients randomized 1:1 to either the LTGO intervention (a 2-phased, supervised, telerehab behavioral exercise program), or to enhanced usual care (activity tracking and monthly newsletters). All study activities, including intervention delivery, recruitment, consenting, assessment, and data collection, will be performed remotely.

Conclusion: If efficacious, this fully scalable and replicable telerehab intervention could be efficiently translated to reach large numbers of lung recipients to improve and sustain self-management of exercise habits by overcoming barriers to participation in existing, in-person pulmonary rehabilitation programs.

Keywords: Behavior change techniques; Lung transplant; Randomized controlled trial; Self-monitoring; Telerehabilitation.

Grants and funding

R01 NR017196/NR/NINR NIH HHS/United States