BreatheWell: Does Breathing Resistance Training Relax the Body and Calm the Mind?
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in Psychological Well-Being
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or higher
- •Stable health for the past 3 months.
排除标准
- •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.
研究组 & 干预措施
IMT
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.
干预措施: Breathing training device (Inspiratory Muscle Training) (Device)
IMT
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.
干预措施: Oura Ring (Device)
IMT Sham
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.
干预措施: Breathing training device (Inspiratory Muscle Training) (Device)
IMT Sham
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.
干预措施: Oura Ring (Device)
Control
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.
干预措施: Oura Ring (Device)
结局指标
主要结局
Change in Psychological Well-Being
时间窗: From enrollment to the completion of the 12-week intervention period, followed by the observational period extending until week 24.
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
Change in Body Awareness
时间窗: From enrollment to the end of the 12-week intervention period, followed by an observational period through week 24.
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
Change in Heart Rate Variability (HRV)
时间窗: From enrollment to the end of the 12-week intervention period, followed by an observational period through week 24.
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)
Change in Inspiratory Muscle Strength
时间窗: From enrollment (first physiology visit) to the end of the 12-week intervention period.
Inspiratory muscle strength will be measured using the PowerBreathe training device and reported in centimeters of water pressure (cmH₂O), representing the pressure generated during inhalation against resistance. Unit of Measure: cmH₂O
Change in Peak Inspiratory Flow Rate
时间窗: From enrollment (first physiology visit) to the end of the 12-week intervention period.
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)
Change in Inhaled Volume per Breath
时间窗: From enrollment (first physiology visit) to the end of the 12-week intervention period.
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)
次要结局
未报告次要终点
研究者
Paul Macey, PhD
Principal Investigator
University of California, Los Angeles