Considerations for assessing physical function and physical activity in clinical trials during the COVID-19 pandemic

Abstract

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 ].

Test/Retest Reliability and Validity of Remote vs. In-Person Anthropometric and Physical Performance Assessments in Cancer Survivors and Supportive Partners

“…Therefore, when faced with the challenges of limiting COVID-19 exposure risk for participants and staff, clinical enterprises adapted rapidly to remote means, with anticipation that virtual care may be “here-to-stay”, given its convenience. Remote observation and assessment also hold great potential within the context of clinical trials for evaluating outcomes efficiently, reliably, and safely [ 21 , 22 ]. Moreover, remote assessments can greatly increase the reach of clinical trials and overcome two of the major barriers to participation: time and travel [ 23 , 24 ].…”

Developing a virtual assessment protocol for the AMPLIFI Randomized Controlled Trial due to COVID-19: From assessing participants' preference to preparing the team

“…Future studies should continue to determine the contexts in which remote assessments of physical functioning are safe, feasible, and a reliable approach to data collection in survivors. The work by Moon and colleagues can offer guidance to researchers [8]. In their study of lung cancer survivors discharged home after lung transplant surgery (4 weeks or more post-surgery), the authors provide detailed considerations for assessing physical activity and physical functioning using remote assessments, outline the implementation process of the remote assessment protocol, and provide a plan for data analysis given the different data collection methods (remote vs. in person) and the use of surrogate measures [8].…”

“…The work by Moon and colleagues can offer guidance to researchers [8]. In their study of lung cancer survivors discharged home after lung transplant surgery (4 weeks or more post-surgery), the authors provide detailed considerations for assessing physical activity and physical functioning using remote assessments, outline the implementation process of the remote assessment protocol, and provide a plan for data analysis given the different data collection methods (remote vs. in person) and the use of surrogate measures [8]. Moreover, further research is needed to improve rapport building and communication.…”

Exercise Progression Protocol for Lung Transplant GO: A Multicomponent Telerehab Exercise Intervention for Patients After Lung Transplantation

“…A full description of adaptations made to the physical function and physical activity assessments during remote administration during the COVID-19 pandemic is described elsewhere. 27 Physical Function Measures 6-Minute Walk Test. The 6-minute walk test (6MWT) measures the distance walked over 6 minutes as a submaximal test of aerobic capacity/endurance.…”

“…Free-standing is permitted if the space does not accommodate standing close to a wall and the patient verbalizes comfort and safety with conducting the assessment. 27 To prevent possible fatigue during testing, the participant is offered frequent rest breaks throughout the assessment. 30-Second Chair-Stand Test.…”