An advanced and structured physical activity program dedicated to supporting individuals with heart failure is set to begin, backed by a consortium of established research and healthcare institutions from Spain and the Netherlands. The initiative, which is currently in the pre-recruitment phase, promises to advance the understanding and management of heart failure symptoms through an evidence-based physical activity protocol.
In this article:
- What changed?
- Who is involved?
- Program goals and benefits
- FAQ
- Conclusion
- Disclaimer
- Full announcement
What changed?
The introduction of a novel behavioral intervention focusing on physical activity is slated to support individuals diagnosed with heart failure. Although the program has not yet begun enrollment as of October 2023, its forthcoming launch is sparking interest among healthcare professionals, clinical researchers, and regulatory experts due to its innovative approach to managing this prevalent cardiological condition.
Heart failure impacts millions globally, leading to significant healthcare costs and affecting the quality of life for patients. Structured physical activity programs have emerged as an important addition to the standard of care, offering potential benefits for symptom management and overall health outcomes. The announcement represents a focused effort to formally assess the implementation of such a program in a clinical trial setting.
Who is involved?
This program is supported by a diverse consortium of contributors. Key contributors include:
- Universidad de Granada, alongside the Department of Physical Education and Sports and its Faculty of Sport Sciences
- Sport and Health University Research Institute (iMUDS), University of Granada, Spain
- University Hospital Virgen de las Nieves
- Hospital Universitario Clínico San Cecilio
- Hospital Santa Ana de Motril
- Mind, Brain and Behaviour Research Centre (CIMCYC)
- Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBEROBN), under Spain’s Instituto de Salud Carlos III
- Department of Medical BioSciences and the Exercise Physiology Research Group at Radboud University Medical Center, The Netherlands
- Instituto de Investigación Biosanitaria IBS Granada
The partnership of these leading institutions emphasizes the scientific rigor and multidisciplinary approach being leveraged to drive meaningful outcomes for patients with heart failure.
Program goals and benefits
The primary intervention being trialed is categorized as behavioral, focusing specifically on structured physical activity programs designed for heart failure patients. By encouraging appropriate levels of physical exertion, the initiative aims to enhance physical and mental health outcomes among participants, reduce symptoms, and potentially improve overall quality of life. Research has continually emphasized the role of tailored exercise regimens in the rehabilitation and management of cardiac diseases, making this program an important addition to existing scientific efforts.
Importantly, the program’s implementation within a clinical trial setting ensures rigorous adherence to both safety and efficacy protocols, aligning with regulatory and ethical standards. Data from this trial could also provide key insights for healthcare policy makers looking to incorporate structured physical activity programs into standard care pathways for heart failure patients.
For medical device regulators and stakeholders, the trial is also an opportunity to observe how devices and digital health tools might complement behavioral health interventions. While the primary intervention here is not a traditional medical device, there could be implications for wearable technology and telehealth applications.
Further details on how the physical activity is structured and measured are anticipated as the recruitment phase progresses.
FAQ
1. When will the program begin recruiting participants?
The program has not started recruitment yet. The exact start date has not been disclosed as of this announcement.
2. Who can participate in the program?
The program is designed for individuals diagnosed with heart failure. Specific inclusion criteria will be detailed during the recruitment phase.
3. Which organizations are funding this research?
The program is sponsored by several organizations, including Universidad de Granada, University of Granada entities, multiple hospitals in Spain, and research institutes such as CIBEROBN and Radboud University Medical Center in the Netherlands.
Conclusion
This structured physical activity program represents a significant step forward in addressing the challenges faced by individuals living with heart failure. Through a collaborative and multidisciplinary approach, the initiative seeks to enhance the quality of life for participants while contributing valuable data for scientific and regulatory advancement. Stakeholders, especially within clinical and regulatory fields, are encouraged to monitor the progress of this project.
Disclaimer
This article is informational and intended for healthcare, clinical, and regulatory professionals. It does not constitute legal advice or specific clinical recommendations. For precise guidance, consult the official sources and your organization’s legal counsel.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07204834?term=medical+device