NCT07005622

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
Last Updated

June 5, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 14, 2025

Last Update Submit

May 27, 2025

Conditions

Inspiratory Muscle TrainingBlood Pressure

Keywords

Maximal Respiratory Pressures

Outcome Measures

Primary Outcomes (1)

  • Maximal Inspiratory Force

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

    Change following 5-6 weeks of training

Secondary Outcomes (4)

  • Blood Pressure

    Change following 5-6 weeks of training

  • Resting Heart Rate

    Change following 5-6 weeks of training

  • Heart Rate Variability

    Change following 5-6 weeks of training

  • Diaphragm Thickness

    Change following 5-6 weeks of training

Other Outcomes (1)

  • Handgrip strength via handgrip dynamometer

    Change following 5-6 weeks of training

Study Arms (2)

Control Group

PLACEBO COMPARATOR

The control group will practice deep breathing exercise 5 times per week

Other: Deep breathing

Experimental Group

EXPERIMENTAL

The experimental group will participate in inspiratory muscle training 5 times per week

Other: O2 Trainer

Interventions

O2 TrainerOTHER

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

Experimental Group
Deep breathingOTHER

Comparator/placebo for the control group

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sam Houston State University College of Osteopathic Medicine

Conroe, Texas, 77304, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

May 14, 2025

First Posted

June 5, 2025

Study Start

March 26, 2024

Primary Completion

July 15, 2024

Study Completion

August 1, 2024

Last Updated

June 5, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)