Year: 2024
Type: article
Study design: Clinical Trial
Abstract: We developed and evaluated the Digital Platform for Exercise (DPEx): a decentralized, patient-centric approach designed to enhance all aspects of clinical investigation of exercise therapy. DPEx integrated provision of a treadmill with telemedicine and remote biospecimen collection permitting all study procedures to be conducted in patient's homes. Linked health biodevices enabled high-resolution monitoring of lifestyle and physiological response. Here we describe the rationale and development of DPEx as well as feasibility evaluation in three different cohorts of patients with cancer: a phase 0a development study among three women with post-treatment primary breast cancer; a phase 0b proof-of-concept trial of neoadjuvant exercise therapy in 13 patients with untreated solid tumors; and a phase 1a level-finding trial of neoadjuvant exercise therapy in 53 men with localized prostate cancer. Collectively, our study demonstrates the utility of a fully digital, decentralized approach to conduct clinical trials of exercise therapy in a clinical population.
Source: npj Digital Medicine
Authors: Whitney P. Underwood, Meghan G. Michalski, Catherine P. Lee, Gina A. Fickera, Su S. Chun, Stefan E. Eng, Lydia Y. Liu, Brandon L. Tsai, Chaya S. Moskowitz, Jessica A. Lavery, Kimberly J. Van Zee, Ginger J. Gardner, Jennifer J. Mueller, Chau T. Dang, Behfar Ehdaie, Vincent P. Laudone, James A. Eastham, Jessica M. Scott, Paul C. Boutros, Lee W. Jones
Language: English
Subfield: General Health Professions
Field: Health Professions
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,790
OpenAlex ID: W4403840754