Embry-Riddle Aeronautical University has announced active recruitment for a clinical trial exploring the effects of breathing training devices and nitrate-based dietary supplements on exercise performance under simulated altitude conditions. This study targets a crucial aspect of training and hypoxia resilience, particularly for healthy adults, athletes, and clinicians managing exercise intolerance. Combining respiratory muscle training (RMT) devices with dietary interventions like beetroot juice concentrate may pave the way for advancements in health and fitness technologies.
In this article:
- What is the focus of the study?
- What interventions are being tested?
- Who could benefit from this research?
What is the focus of the study?
This trial dives into mechanisms improving exercise tolerance during hypoxia, mimicking high-altitude conditions, with objectives tailored to both short-term resilience and long-term training performance. Currently sponsored by Embry-Riddle Aeronautical University, the research aims to dissect how respiratory muscle training and nitrate supplementation influence physical exertion capacity. Findings could address gaps in therapeutic strategies for individuals with mechanical ventilation dependence or exercise intolerance.
What interventions are being tested?
Participants will be divided into cohorts receiving targeted interventions including:
- Respiratory Muscle Training (RMT) device aimed at improving inspiratory strength and endurance.
- Sham Respiratory Muscle Training device for control group assessments, ensuring unbiased outcome interpretations.
- Beetroot juice concentrate and placebo beverages to analyze the dietary nitrate’s role in physiological adaptation.
The devices and supplements align with regulatory standards, holding potential applications for medical devices and sports performance enhancement.
Who could benefit from this research?
The study focuses on healthy adults interested in augmented exercise outcomes under altered oxygen availability, as well as medical professionals guiding pulmonary rehabilitation techniques. Key populations include:
- Athletes seeking edge-through-altitude training simulations.
- Individuals experiencing exercise intolerance due to respiratory or metabolic constraints.
- Clinical teams evaluating devices qualifying under MDR regulations for respiratory therapies.
The trial’s findings could shape future device classifications and provide new dietary supplement claims for fitness markets.
FAQ
1. What is beetroot juice concentrate?
Beetroot juice concentrate is a nitrate-rich dietary supplement used to improve oxygen transport and stamina during exercise.
2. What are respiratory muscle training devices?
These devices facilitate strength and endurance in the inspiratory and expiratory muscles, lending to better performance under physical strain.
3. Why is altitude simulation important?
Simulating altitude conditions provides insight into hypoxia management and adaptive training strategies that mimic environments with reduced oxygen.
Conclusion
This clinical trial promises to unlock meaningful data about exercise adaptations through innovative device and dietary interventions. Stakeholders in fitness technologies and therapeutic advancements should monitor outcomes closely for potential regulatory impacts.
Disclaimer
This information provides a non-exhaustive overview for professionals working in clinical and regulatory contexts. It is not legal or medical advice.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07216755?term=medical+device