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| ID | Type | Description | Link |
|---|---|---|---|
| 20233469 | Other Grant/Funding Number | Tiny Blue Dot Inc |
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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:
Participants will be randomly assigned to three groups:
Participants will:
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:
Key Outcome Measures:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMT | Experimental | 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. |
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| IMT Sham | Sham Comparator | 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. |
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| Control | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathing training device (Inspiratory Muscle Training) | Device | Daily inspiratory muscle training (IMT) using the PowerBreathe IMT K3 device at varying resistance levels (15% for Sham and 65% for Experimental group) for 12 weeks. Participants will perform breathing exercises designed to assess the effects of different resistance levels on overall physical and emotional well-being, with a focus on how varying resistance impacts both respiratory strength and well-being. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Psychological Well-Being | Psychological well-being will be assessed using the NIH Toolbox Psychological Well-Being Scale. This instrument evaluates life satisfaction, positive emotions, and sense of purpose. Higher scores indicate greater psychological well-being. Unit of Measure: Standardized scale score | From enrollment to the completion of the 12-week intervention period, followed by the observational period extending until week 24. |
| Change in Body Awareness | Body awareness will be assessed using the Multidimensional Assessment of Interoceptive Awareness (MAIA), a validated questionnaire examining emotional awareness, body listening, and self-regulation. Higher scores indicate greater interoceptive awareness. Unit of Measure: Questionnaire scale score | From enrollment to the end of the 12-week intervention period, followed by an observational period through week 24. |
| Change in Heart Rate Variability (HRV) | Heart rate variability will be assessed using the Root Mean Square of Successive Differences (RMSSD), reported in milliseconds. RMSSD reflects parasympathetic nervous system activity, with higher values indicating greater physiological relaxation. Unit of Measure: Milliseconds (ms) | From enrollment to the end of the 12-week intervention period, followed by an observational period through week 24. |
| Change in Inspiratory Muscle Strength | Inspiratory muscle strength will be measured using the PowerBreathe training device and reported in centimeters of water pressure (cmHâ‚‚O), representing the pressure generated during inhalation against resistance. Unit of Measure: cmHâ‚‚O | From enrollment (first physiology visit) to the end of the 12-week intervention period. |
| Change in Peak Inspiratory Flow Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Macey, PhD | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA School of Nursing, Factor Bldg, 700 Tiverton Dr | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Oura Ring | Device | The Oura ring measures daily biometrics such as heart rate, sleep, and blood oxygen levels, providing personalized health data and insights. Participants have access to this data through a mobile app, allowing researchers to assess whether increased access to health data and awareness has an impact on overall physical and emotional well-being. |
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Peak inspiratory flow rate will be measured using the PowerBreathe training device and recorded in liters per minute (L/min), indicating the maximum airflow achieved during inhalation.
Unit of Measure: Liters per minute (L/min)
| From enrollment (first physiology visit) to the end of the 12-week intervention period. |
| Change in Inhaled Volume per Breath | Inhaled volume per breath will be assessed using the PowerBreathe training device and measured in milliliters (mL), indicating changes in lung capacity throughout the intervention. Unit of Measure: Milliliters (mL) | From enrollment (first physiology visit) to the end of the 12-week intervention period. |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |