Addressing COVID-19 challenges in a randomised controlled trial on exercise interventions in a high-risk population.

Area of Science:

• Gerontology and Rehabilitation Medicine
• Clinical Trial Management
• Telemedicine and Digital Health

Background:

• The COVID-19 pandemic posed significant risks to ongoing clinical trials, especially those involving high-risk elderly participants requiring in-person contact.
• Chronically ill elderly individuals need regular physical activity and social interaction for health, conflicting with pandemic-related restrictions.
• The ENTAIER trial, focused on mindful movements to reduce fall risk in elderly individuals, faced disruption due to lockdowns.

Purpose of the Study:

• To identify challenges and solutions for adapting the ENTAIER randomized controlled trial to a telemedicine format.
• To ensure the continued high quality, efficacy, and safety of the trial interventions.
• To maintain participant motivation and human connection within a remote exercise program.

Main Methods:

• Conducted a literature review on telemedicine quality and feasibility in exercise training for the elderly.
• Participated in international telemedicine task forces focusing on integrative and mind-body medicine.
• Interviewed therapists, personnel, experts, and patient representatives regarding live telecommunication for mindful movement exercises and physiotherapy.

Main Results:

• Identified key challenges including technical equipment, user proficiency, participant/therapist concerns, safety, data protection, and study design.
• Explored two primary continuation strategies: a full transition to telemedicine or a hybrid approach integrating risk management.
• Highlighted the need for robust solutions to manage technology and ensure effective remote intervention delivery.

Conclusions:

• Adapting clinical trials to telemedicine during crises requires careful planning and implementation.
• Checklists for trial continuation and telemedicine implementation can guide researchers and healthcare providers.
• The ENTAIER trial's experience provides valuable insights for managing ongoing studies in similar crisis scenarios.