150 Participants Needed

Breathing Exercises for Healthy Subjects

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial excludes people who have used cardiovascular or psychotropic medications in the past 3 months, so you would need to stop these medications to participate.

What data supports the effectiveness of the treatment Breathing training device (Inspiratory Muscle Training)?

Research shows that inspiratory muscle training (IMT) using devices can improve breathing muscle strength and reduce breathlessness in people with chronic lung conditions like COPD. This suggests that similar benefits might be seen in healthy individuals using the same type of training.12345

Is inspiratory muscle training safe for humans?

Inspiratory muscle training (IMT) is generally considered safe for humans, as studies have shown it to be safe and effective in improving respiratory muscle function in patients with chronic conditions and those in intensive care. No significant safety concerns have been reported in the research available.26789

How is the breathing training device treatment different from other treatments for breathing issues?

The breathing training device, used for inspiratory muscle training, is unique because it provides real-time feedback on breathing characteristics, allowing for personalized adjustments to maximize respiratory muscle work and power. This approach is different from other treatments as it focuses on enhancing the strength and endurance of respiratory muscles through tailored resistance training.79101112

What is the purpose of this trial?

The goal of this study is to determine whether tasks related to breathing training (daily inspiratory muscle training (IMT) and increased access to health data/awareness) performed for 12 weeks leads to positive changes in mental and physical states, and if these changes are sustained three months later. The study will assess whether IMT, compared to a sham IMT and the control group, improves psychological well-being, body awareness, and physical relaxation. Although there is evidence that all three interventions make a difference, the extent of their impact is yet to be determined, so the study aims to compare the effectiveness of the interventions, aiming to determine which may be most beneficial.The main questions the study aims to answer are:* Do tasks related to breathing training (high resistance IMT, low resistance IMT, or access to health data) performed over 12 weeks enhance mental and physical well-being?* Are the changes in mental and physical states sustained three months post-intervention?* Is IMT more effective than sham IMT or simple health data engagement in improving well-being?* Who benefits from each intervention?Participants will be randomly assigned to three groups:* IMT: Daily inspiratory muscle training at a moderate to high resistance.* Sham IMT: Daily inspiratory muscle training at a low resistance.* Control: Participants will track their health data but not engage in IMT.Participants will:* Engage in daily IMT or sham IMT training for 12 weeks.* Engage with the Oura ring and app by checking in daily to sync the ring's data and review personal health insights.* Complete daily and weekly surveys tracking mental and physical health.* Have biometric data collected at baseline, post-intervention (12 weeks), and at a 3-month follow-up.

Research Team

PM

Paul Macey, PhD

Principal Investigator

Professor

Eligibility Criteria

This trial is for people with respiratory aspiration issues or healthy individuals interested in exploring how breathing training might affect their mental and physical well-being. Participants will be involved in daily activities and surveys for 12 weeks, plus follow-ups.

Exclusion Criteria

I should avoid activities that increase pressure in my chest or sinuses.
I recently started practicing mind-body techniques.
Diagnosed psychotic disorders
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in daily inspiratory muscle training (IMT) or sham IMT for 12 weeks, with health data engagement using the Oura ring.

12 weeks
Daily engagement with IMT or health data tracking

Follow-up

Participants are monitored for sustained changes in mental and physical states three months post-intervention.

12 weeks
Data collection at 3-month follow-up

Treatment Details

Interventions

  • Breathing training device (Inspiratory Muscle Training)
Trial Overview The study tests if a breathing training device (IMT) can improve psychological health, body awareness, and relaxation over 12 weeks. It compares high resistance IMT, low resistance IMT (sham), and just tracking health data without IMT.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: IMTExperimental Treatment2 Interventions
Participants will perform Inspiratory Muscle Training (IMT) using the PowerBreathe IMT K3 device at 65% resistance, focusing on the effects of higher resistance training on respiratory strength, physical well-being, and emotional well-being.
Group II: ControlActive Control1 Intervention
Participants will not undergo the IMT procedure and will instead receive general health awareness through the Oura ring (a biometric ring and app), serving as the baseline group for comparison.
Group III: IMT ShamPlacebo Group2 Interventions
Participants will perform the IMT procedure using the PowerBreathe IMT K3 device at 15% resistance to assess the effects of lower resistance on overall physical and emotional well-being, compared to higher resistance training.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

Findings from Research

Inspiratory muscle training (IMT) has been shown to significantly improve symptoms and quality of life in COPD patients, particularly through the use of specialized devices like AirOFit PRO™ and PowerBreath®.
The latest guidelines emphasize the importance of personalized respiratory rehabilitation programs, highlighting IMT as a beneficial component for enhancing health status and well-being in individuals with COPD.
Inspiratory Muscle Training in Patients with Chronic Obstructive Pulmonary Disease (COPD) as Part of a Respiratory Rehabilitation Program Implementation of Mechanical Devices: A Systematic Review.Vázquez-Gandullo, E., Hidalgo-Molina, A., Montoro-Ballesteros, F., et al.[2023]
An electronic inspiratory loading device was validated for assessing breathing characteristics during inspiratory muscle training (IMT) in patients with weaning difficulties, showing good to excellent agreement with a reference spirometer across 1002 breaths from 27 training sessions.
The device allows for real-time feedback on breathing effort, enabling adjustments to the training load, which can enhance respiratory muscle function and potentially improve weaning outcomes for patients with chronic obstructive pulmonary disease.
Measurement validity of an electronic training device to assess breathing characteristics during inspiratory muscle training in patients with weaning difficulties.Van Hollebeke, M., Poddighe, D., Gojevic, T., et al.[2021]

References

Inspiratory muscle training protocol using a pressure threshold device: effect on dyspnea in chronic obstructive pulmonary disease. [2019]
Effects of two types of equal-intensity inspiratory muscle training in stable patients with chronic obstructive pulmonary disease: A randomised controlled trial. [2018]
Predictors of positive outcomes following resistive inspiratory muscle training in non-ambulatory persons with advanced multiple sclerosis. [2022]
Respiratory muscle training with the incentive spirometer resistive breathing device. [2006]
Inspiratory Muscle Training in Patients with Chronic Obstructive Pulmonary Disease (COPD) as Part of a Respiratory Rehabilitation Program Implementation of Mechanical Devices: A Systematic Review. [2023]
Inspiratory muscle training in intensive care unit patients: An international cross-sectional survey of physiotherapist practice. [2022]
7.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[The EOL trainer for respiratory muscles]. [2006]
The impact of resistance respiratory muscle training with a SpiroTiger(®) device on lung function, exercise performance, and health-related quality of life in respiratory diseases. [2020]
Measurement validity of an electronic training device to assess breathing characteristics during inspiratory muscle training in patients with weaning difficulties. [2021]
Inspiratory muscle training in COPD patients. [2007]
11.United Statespubmed.ncbi.nlm.nih.gov
Behavioral interventions in asthma. Breathing training. [2022]
Evaluation of the effectiveness of a home-based inspiratory muscle training programme in patients with chronic obstructive pulmonary disease using multiple inspiratory muscle tests. [2015]
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