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Completed

NCT Number: NCT07005622

Inspiratory Muscle Training Using the O2 Trainer

This study aims to investigate the effects of resistive inspiratory training using the O2 Trainer on cardiopulmonary outcomes in healthy individuals.

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Key information

Conditions

Inspiratory Muscle Training Blood Pressure

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sam Houston State University College of Osteopathic Medicine

Conroe, Texas, 77304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-65
  • Able to participate in training 5 days per week

Exclusion criteria

  • Previous ventilation
  • Diagnosed chronic obstructive pulmonary disease (COPD)
  • Uncontrolled asthma
  • Previous ear drum rupture
  • Previous abdominal hernia
  • Acute respiratory infection
  • Currently pregnant

Treatment and study plan

O2 Trainer

Other

The O2 Trainer uses varying caps to limit airflow during inspiration.

deep breathing

Other

Comparator/placebo for the control group

Primary outcomes

  1. Maximal Inspiratory Force

    Time frame: Change following 5-6 weeks of training

    Inspiratory force (mmHg) will be measured using a digital pressure gauge connected to a mouthpiece.

Secondary outcomes

  1. Blood Pressure

    Time frame: Change following 5-6 weeks of training

    mmHG measured by FDA approved automated blood pressure cuff.

  2. Resting Heart Rate

    Time frame: Change following 5-6 weeks of training

    Beats per minute, measured using a chest worn heart rate monitor.

  3. Heart Rate Variability

    Time frame: Change following 5-6 weeks of training

    Measured using a chest worn heart rate monitor.

  4. Diaphragm Thickness

    Time frame: Change following 5-6 weeks of training

    Measured by ultrasound

Other outcomes

  1. Handgrip strength via handgrip dynamometer

    Time frame: Change following 5-6 weeks of training

    Strength of handgrip will be recorded as kg of force using a handgrip dynamometer.

Sponsors and collaborators

Lead sponsor

Sam Houston State University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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