Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
Healthy Volunteers
ID07216755

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

Led by Embry-Riddle Aeronautical University · Updated on 2025-10-15

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether respiratory muscle training (RMT) and dietary nitrate supplementation can improve exercise tolerance under moderate altitude conditions where oxygen is limited. The study focuses on healthy, recreationally active adults aged 18 to 40 without heart, lung, or metabolic diseases. By combining breathing muscle strengthening and nitrate therapy, which enhances blood vessel function, the study aims to find non-drug methods to enhance oxygen delivery and reduce physical strain during exercise in low-oxygen environments. Participants will be randomly assigned to one of four groups: RMT with nitrate supplement, RMT with placebo, sham RMT with nitrate supplement, or sham RMT with placebo. The RMT involves using a handheld breathing device with resistance five days a week for 4 to 6 weeks, while the nitrate group consumes daily concentrated beetroot juice. Sham groups use a low-resistance device or placebo drink that looks and tastes like the nitrate supplement but lacks active ingredients. Participants will undergo exercise tests on a stationary bike before and after the intervention, both at normal oxygen and simulated altitude. Researchers will measure exercise duration, oxygen use, heart rate, breathing, blood pressure, muscle oxygen levels, and respiratory muscle strength. The main outcome is change in exercise tolerance after 4 to 6 weeks. The study includes monitoring of physiological responses to understand how the treatments affect breathing and cardiovascular function during exercise.

CONDITIONS

Brief Title

Effects of Breathing Training and Nitrate on Exercise at Simulated Altitude

Who Can Participate

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adults between 18 and 40 years old
  • Recreationally active, performing at least 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
  • Able to perform cycle ergometer exercise to volitional fatigue
  • Willing to avoid high-nitrate foods and supplements for 48 hours before testing sessions
  • Able and willing to provide written informed consent and comply with study procedures
Not Eligible

You will not qualify if you...

  • Diagnosis or history of heart disease, hypertension, diabetes, or chronic respiratory disorders such as asthma or COPD
  • Current use of medications or supplements affecting cardiovascular, metabolic, or respiratory function
  • Smoking, vaping, or tobacco use within the past 6 months
  • Known allergy or intolerance to beetroot products or nitrates
  • Participation in another interventional research study in the past 30 days
  • Pregnant or breastfeeding women
  • Orthopedic or musculoskeletal limitations preventing safe exercise testing
  • Failure to meet inclusion criteria or inability to complete baseline testing

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 4 to 6 weeks

Participants perform respiratory muscle training using a handheld device several times per week and consume a daily beetroot juice supplement or placebo for approximately 4 to 6 weeks to test effects on breathing muscle strength and exercise tolerance.

Training sessions 5 days per week and daily supplement intake

Monitoring

Duration - Short visits before and after intervention

Before and after the intervention, participants complete exercise tests at normal and simulated altitude to measure exercise performance and physiological responses.

2 visits (in-person) for pre- and post-intervention exercise testing

Trial Site Locations

Total: 1 location

1

Embry-Riddle Aeronautical University

Daytona Beach, Florida, United States, 32114

Actively Recruiting

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Research Team

S

Scott Ferguson K Ferguson, Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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