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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether breathing exercises can improve mental and physical well-being over 12 weeks and if these improvements persist three months later. Participants will be divided into three groups: one using a breathing training device for high-resistance exercises, another using the device with low resistance, and a control group that only tracks health data. The researchers aim to determine which approach most effectively enhances overall well-being. This trial suits individuals who have been healthy for the past three months and do not regularly use personal health tracking devices. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future health practices.

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 prior data suggests that this breathing training device is safe for healthy subjects?

Research has shown that Inspiratory Muscle Training (IMT) is generally safe. Studies have found that using the IMT device can safely enhance fitness levels. For example, one study found that IMT helped lower blood pressure without causing any issues. Another study demonstrated that IMT improved exercise ability safely, enabling better workouts without negative health effects. Additionally, the PowerBreathe device used in these studies is considered easy to use and comfortable for most people. Overall, IMT is well-tolerated, with no major safety concerns reported.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different resistance levels in breathing training can impact respiratory, physical, and emotional well-being. Unlike traditional breathing exercises, which often involve general deep breathing techniques, this trial uses a device called the PowerBreathe IMT K3 to deliver targeted inspiratory muscle training (IMT) at varying resistance levels. This approach could reveal how higher resistance training at 65% might bolster respiratory strength and overall well-being, compared to lower resistance at 15% or general health awareness. By understanding these differences, researchers hope to uncover more effective ways to enhance respiratory health and well-being.

What evidence suggests that this trial's breathing training interventions could be effective for improving mental and physical well-being?

Studies have shown that training the muscles used for breathing, known as inspiratory muscle training (IMT), can ease breathing and reduce breathlessness. This improvement can enhance the ability to perform daily activities. Research indicates that people with serious lung diseases who used IMT experienced less shortness of breath and improved mobility. In this trial, participants in the IMT arm will use the POWERbreathe device at 65% resistance to assess the effects of higher resistance training on respiratory strength, physical well-being, and emotional well-being. Participants in the IMT Sham arm will use the device at 15% resistance to evaluate the effects of lower resistance. These findings suggest that both high and low levels of IMT can improve physical and emotional well-being, though benefits may vary among individuals.678910

Who Is on the Research Team?

PM

Paul Macey, PhD

Principal Investigator

Professor

Are You a Good Fit for This Trial?

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.
Diagnosed psychotic disorders
I recently started practicing mind-body techniques.
See 3 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: IMTExperimental Treatment2 Interventions
Group II: ControlActive Control1 Intervention
Group III: IMT ShamPlacebo Group2 Interventions

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+

Published Research Related to This Trial

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]

Citations

POWERbreathe K3 for Inspiratory Muscle TrainingReference values for respiratory muscle strength measured with the Strength-Index® Test in well-trained athletes, e-sports athletes and age-matched controls.
The effects of inspiratory muscle training based on ...Inspiratory muscle training reduces breathlessness in advanced lung disease patients. Inspiratory muscle training improves daily activities, mobility and ...
Optimize Performance Using POWERbreathe Strength- ...POWERbreathe's Strength-Index® is a measure of inspiratory muscle strength based on the maximum flow of inhaled air the user can generate.
BreatheWell: Train Your Breathing, Relax Your Body, Open ...This study seeks to investigate the impact of daily inspiratory muscle training (IMT) over 12 weeks on mental and physical well-being.
Inspiratory Muscle Training Program Using the PowerBreathThis systematic review and meta-analysis aim to provide scientific evidence regarding the effects of training on respiratory muscle training's impact with ...
Inspiratory muscle training in children and adolescents living ...Inspiratory muscle training (at an intensity of 30% Pimax) appears safe, feasible and acceptable, in a small sample of children and adolescents with NMD.
Natural Ways To Lower Blood Pressure Quickly | IMSTThis natural home remedy has shown significant promise in reducing high blood pressure levels. Findings also show POWERbreathe IMST to be safe ...
Is inspiratory muscle training (IMT) an acceptable treatment ...Adherence with IMT was assessed by the Powerbreathe K3 device and participant diaries. Uptake of PR was identified. Results IMT was found to be acceptable.
Time‐Efficient Inspiratory Muscle Strength Training Lowers ...We show that 6 weeks of IMST reduced casual SBP, our primary outcome, and largely maintained this reduction following cessation from training.
Breathing Pattern Response after 6 Weeks of Inspiratory ...The main practical application is that IMT is an effective and safe intervention that enhances exercise capacity without causing changes or ...
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