Effects of Breathing Training and Nitrate on Exercise at Simulated Altitude

Conditions

• Dietary Supplement
• Exercise Intolerance
• Exercise Training
• Healthy Adults
• Hypoxia
• Inspiratory Muscle Training
• Mechanical Ventilation Dependence
• Nitrate Supplementation

Eligibility Criteria

Sex

ALL

Age

18 Years - 40 Years

Healthy Volunteers

Accepted

Interventions

• Respiratory Muscle Training (RMT) — DEVICE
  Participants perform supervised respiratory muscle training (RMT) using a handheld resistive breathing device designed to strengthen the inspiratory and expiratory muscles. Training sessions are conducted 5 days per week for approximately 4-6 weeks. Each session includes a series of resisted breathing maneuvers with progressively increased load as tolerated. The device is calibrated to maintain a constant pressure threshold to ensure consistent training intensity.
• Sham Respiratory Muscle Training — DEVICE
  Participants use an identical handheld breathing device with minimal resistance, providing no meaningful training stimulus. The training schedule and session duration match those of the active RMT group to maintain participant blinding.
• Dietary Supplement: Beetroot Juice Concentrate — DIETARY_SUPPLEMENT
  Participants consume a standardized dose of concentrated beetroot juice daily for the duration of the training period (approximately 4-6 weeks). The supplement provides a fixed quantity of dietary nitrate known to enhance nitric oxide availability and support vascular and metabolic function during exercise.
• placebo beverage — DIETARY_SUPPLEMENT
  Participants consume a placebo beverage identical in color, taste, and appearance to the nitrate supplement but containing no active nitrate. The beverage is consumed daily following the same schedule as the active supplement.

Study Details

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.

Key Dates

Start date

Sep 1, 2025

Status verified

Oct 2025

Primary completion

Aug 31, 2028

Completion

Aug 31, 2028

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

BASIC_SCIENCE

Arms

• 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.

Primary Outcome Measure

Change in Exercise Tolerance at Simulated Altitude [ Time Frame: Baseline to Post-Intervention (approximately 4-6 weeks) ]

Central Contacts

• Scott Ferguson K Ferguson, Ph.D.
  386-226-7381
  [email protected]

Locations (1)

Find similar trials in Daytona Beach, FL

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