The coronavirus disease-2019 (COVID-19) pandemic has changed the conduct of clinical trials. For studies with physical function and physical activity outcomes that require in-person participation, thoughtful approaches in transitioning to the remote research environment are critical. Here, we share our experiences in transitioning from in-person to remote assessments of physical function and activity during the pandemic and highlight key considerations for success. Details on the development of the remote assessment protocol, integration of a two-way video platform, and implementation of remote assessments are addressed. In particular, procedural challenges and considerations in transitioning and conducting remote assessments will be discussed in terms of efforts to maintain participant safety, maximize study efficiency, and sustain trial integrity. Plans for triangulation and analysis are also discussed. Although the role of telehealth platforms and research activities in remote settings are still growing, our experiences suggest that adopting remote assessment strategies are useful and convenient in assessing study outcomes during, and possibly even beyond, the current pandemic.
Trial register and number:
ClinicalTrials.gov
[
NCT03728257
].
Lung transplantation is one of the fastest growing solid organ transplant procedures in the United States. After transplantation, lung function typically returns to near normal levels; however, reduced physical function and an inactive lifestyle compromise this benefit. To promote rehabilitation goals, lung transplant recipients (LTRs) are advised to participate in pulmonary rehab, but participation is low due to barriers related to scheduling, travel requirements, lack of insurance coverage, and the concern about exposure to infection. Telerehabilitation offers a flexible alternative with the potential to promote self-management of exercise in LTRs. The purpose of this report was to describe the exercise progression protocol for the Lung Transplant GO multicomponent telerehab exercise intervention for patients after lung transplantation. The progression protocol is an evidence-informed exercise protocol designed to improve physical function and physical activity in LTRs safely and effectively in a remote environment. The protocol standardizes the prescription of exercise while permitting adaptation of the program to meet the needs of the individual. Using this model, the decisions about program progression are systematic, transparent, and replicable to other LTRs.
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