Addressing COVID-19 Challenges in a Randomized Controlled Trial on Exercise Interventions in a High-risk Population
Authors: Kienle Gunver , Werthmann Paul , Grotejohann Birgit , Hundhammer Theodor , Schmoor Claudia , Christoph Stumpe , Voigt-Radloff Sebastian , Huber Roman 
Published: November 2020

Abstract
Background: The coronavirus disease 2019 (COVID-19) pandemic is a threat to ongoing clinical trials necessitating regular face-to-face, in-person meetings, particularly in participants with a high risk of complications. Guidance on how to handle and safely continue such trials is lacking. Chronically ill elderly individuals require—in addition to protection from infection—regular physical exercise and social contacts to remain healthy. Solutions for these conflicting necessities are needed.Methods: The ENTAIER randomized controlled trial is investigating the influence of mindful movements on fall risk, fear of falling, mobility, balance, quality of life, and other outcomes. The study population consists of 550 chronically ill elderly individuals with a high risk of falling. The movements are regularly performed in coached groups over 6 months. After the trial began, COVID-19 lock-downs stopped all in-person meetings, and it was expected that the limitations of this pandemic would continue long term. Therefore, the exercise program, which involve complex movements and is typically conducted face-to-face in groups, had to be substituted by a telemedicine program within a short timeframe. The objectives, therefore, were to identify challenges and tasks that need to be resolved and steps that need to be taken to achieve high-quality, efficacy, safety, and enable human encounter and motivation. We proceeded with four steps: 1) A literature review on quality and feasibility issues of telemedicine in general and specifically in exercise training in elderly individuals. 2) Participation in two international telemedicine task forces on integrative medicine, particularly mind-body medicine for cancer patients. 3) A broad discussion and interviews with study therapists,[1] personnel, and international experts on providing mindful movement exercises and other physiotherapies via live telecommunication technology, and with scientists and patient representatives. 4) A review and final evaluation of the core trial team and subsequent planning and implementation of changes. Results and Conclusions: A variety of tasks and challenges were identified for the technical equipment for therapists and patients, ability of therapists and trial participants to adequately manage the technology and telemedicine intervention, reservations and concerns about the technology among therapists and participants, safety and data protection in using the technology, and study design. Steps and possible solutions led to solutions for both a complete switch to telemedicine and a partial switch in the form of risk management pertaining to the former design and implementation. These steps and possible solutions may also inform other researchers or health care providers confronted with similar challenges in the current situation or similar future scenarios.Trail registration: www.drks.de. DRKS00016609. Registered 30th July 2019.