Clinical trial NCT06920407: BreatheWell: Train Your Breathing, Relax Your Body, Open Your Mind
Official title: BreatheWell: Does Breathing Resistance Training Relax the Body and Calm the Mind?
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthy
Keywords: Breathing
Stress
Breathing Training
Inspiratory Muscle Training
Breathing resistance training
Interoception
Physical and mental well-being
Health tracking
Oura
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: This study seeks to investigate the impact of daily inspiratory muscle training (IMT) over 12 weeks on mental and physical well-being, focusing on whether the effects are sustained three months post-intervention. IMT is a breathing exercise known to improve respiratory function and reduce stress. This research will expand on previous findings showing that IMT can influence psychological states, such as increased awareness of the body, and improved relaxation and well-being. The investigators aim to compare the effects of IMT against a sham IMT group and a health data engagement-only group, assessing whether daily IMT enhances psychological well-being, body awareness, and physical relaxation.

Study Design and Groups:

* IMT Group: Participants will engage in daily inspiratory muscle training with the Powerbreathe device at moderate to high resistance, aimed at improving respiratory strength and exploring the effects of higher resistance training on well-being.
* Sham IMT Group: This group will complete daily IMT sessions at low resistance. This type of training encourages slower, deeper breaths, which some participants have found to help with relaxation and improving breath control.
* Engagement-Only Group: Participants will wear the Oura ring, which tracks health metrics such as heart rate, sleep, and physical activity. They will engage with the app to sync their data and review personal insights, fostering health awareness and self-monitoring.

Key Outcome Measures:

* Psychological Well-Being: Evaluated using the NIH Toolbox Psychological Well-Being (PWB) test.
* Body Awareness: Assessed with the Multidimensional Assessment of -Interoceptive Awareness (MAIA) scale.
* Physical Relaxation: Measured by heart rate variability (RMSSD), which reflects vagal tone and overall relaxation.

Study Procedures:

Participants will complete their assigned interventions for 12 weeks, with data collection at baseline, post-intervention (12 weeks), and at a 3-month follow-up. All participants will be asked to engage with weekly surveys to track their mental and physical health. The study also measures adherence, age, gender, physical activity, and sleep quality as potential confounding factors to better understand the broader impacts of the interventions.

This study aims to compare the effects of IMT at different resistance levels to see if it improves well-being, whether these benefits are maintained over time, and how it compares to simply engaging with health-tracking data.

Eligibility criteria: Inclusion Criteria:

* Age 18 or higher
* Stable health for the past 3 months.

Exclusion Criteria:

* IMT contraindications which relate to people who should not raise lung, thoracic, or sinus pressures
* Current or recent (\< 3 months) use of cardiovascular or psychotropic medications
* Diagnosed psychotic disorders
* Current participation in therapy
* Recent initiation of mind-body practice
* Current major illness or injury
* Regular use of personal tracking devices to monitor sleep, heart rate, activity, or related physiological data.

Primary outcomes:
measure: Change in Psychological Well-Being
timeFrame: From enrollment to the completion of the 12-week intervention period, followed by the observational period extending until week 24.
measure: Change in Body Awareness
timeFrame: From enrollment to the end of the 12-week intervention period, followed by an observational period through week 24.
measure: Change in Heart Rate Variability (HRV)
timeFrame: From enrollment to the end of the 12-week intervention period, followed by an observational period through week 24.
measure: Change in Inspiratory Muscle Strength
timeFrame: From enrollment (first physiology visit) to the end of the 12-week intervention period.
measure: Change in Peak Inspiratory Flow Rate
timeFrame: From enrollment (first physiology visit) to the end of the 12-week intervention period.
measure: Change in Inhaled Volume per Breath
timeFrame: From enrollment (first physiology visit) to the end of the 12-week intervention period.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA School of Nursing, Factor Bldg, 700 Tiverton Dr
state: California
Study officials:
affiliation: Professor
name: Paul Macey, PhD
role: PRINCIPAL_INVESTIGATOR
References: