Impact of Respiratory Muscle Training and Nitrate Therapy on Exercise Tolerance in Simulated Altitude

Status: Recruiting
Location: See location...
Intervention Type: Device, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study investigates whether respiratory muscle training (RMT) and dietary nitrate supplementation can improve exercise tolerance under simulated moderate altitude conditions. Exposure to reduced oxygen availability at altitude places additional strain on the cardiovascular and respiratory systems, which may limit endurance performance. By combining RMT-designed to strengthen the muscles involved in breathing-with nitrate therapy, which enhances nitric oxide availability and vascular function, this study aims to determine whether these interventions independently or synergistically improve oxygen delivery, reduce physiological strain, and enhance exercise performance. The findings will help identify non-pharmacological strategies to improve physical performance and tolerance to hypoxia in both clinical and operational environments.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
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• Healthy adults between 18 and 40 years old.

⁃ Recreationally active (performing ≥3 hours of structured physical activity per week).

⁃ Non-smokers for at least the past 6 months.

⁃ Free from any known cardiovascular, pulmonary, metabolic, or neuromuscular disease as determined by health screening questionnaire and medical history.

⁃ Able to perform cycle ergometer exercise to volitional fatigue.

⁃ Willing to abstain from high-nitrate foods and supplements (e.g., beets, spinach, arugula) for 48 hours prior to each testing session.

⁃ Able and willing to provide written informed consent and comply with all study procedures.

Locations
United States
Florida
Embry-Riddle Aeronautical University
RECRUITING
Daytona Beach
Contact Information
Primary
Scott Ferguson K Ferguson, Ph.D.
ferguss8@erau.edu
386-226-7381
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 80
Treatments
Experimental: RMT + Nitrate Supplementation
Participants complete a multi-week respiratory muscle training (RMT) program using a handheld breathing device that provides progressive inspiratory and expiratory resistance. Participants also consume a daily standardized dose of beetroot juice concentrate containing dietary nitrate. This combination is expected to enhance breathing muscle strength, vascular function, and exercise tolerance under simulated altitude.
Placebo_comparator: Respiratory Muscle Training + Placebo
Participants perform the same RMT program as in Arm 1 but consume a placebo beverage that is visually and taste-matched to the nitrate drink but contains no active nitrate. This group allows assessment of the independent effects of respiratory muscle training.
Sham_comparator: Sham Respiratory Muscle Training + Nitrate Supplementation
Participants perform sham RMT with a very low resistance load that does not provide a training stimulus, while consuming the active nitrate beverage daily. This group isolates the independent effect of nitrate supplementation on exercise tolerance under hypoxic conditions.
Placebo_comparator: Sham Respiratory Muscle Training + Placebo
Participants complete sham RMT with minimal breathing resistance and consume a placebo beverage identical in appearance and flavor to the nitrate supplement but containing no active ingredients. This serves as the control condition for comparison with all other intervention groups.
Related Therapeutic Areas
Sponsors
Leads: Embry-Riddle Aeronautical University

This content was sourced from clinicaltrials.gov