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| ID | Type | Description | Link |
|---|---|---|---|
| K99AT010158-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The purpose of this research study is to determine the influence of yoga breathing practices on cerebrospinal fluid (CSF) circulation, and to find out primarily if a regular practice of 8-week yoga breathing would enhance CSF circulation as well as if the intervention would improve participant's quality of life, quality of sleep, and reduce existing stress. Participants will be randomized into two arms for different breathing practices.
The purpose of this research protocol is to determine the influence of an 8-week breathing intervention on cerebrospinal fluid (CSF) circulation among healthy participants using a non-invasive real-time phase-contrast magnetic imaging (RT-PCMRI) technique. This aim will be examined by studying the changes in each participant's pre- and post-intervention CSF flow dynamics using the non-invasive RT-PCMRI technique during two MRI scans (one before and one after the 8-week intervention).
The study protocol consists of 20 healthy participants (two groups; 10 in each group with different breathing practices) undergoing an 8-week intervention, and pre-and post-intervention outcome measures.
The two 8-week interventions will be guided by two separate certified experienced yoga teachers. Both interventions will consist of 60-minute weekly group on-site sessions (1day/week) with a 20-minute daily home sessions (in between on-site sessions; 6 days/week) using home-aid practice materials. Participants' respiration data will be objectively tracked using a wearable respiration tracker device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breathing Group 1 | Experimental | Arm 1 will receive an 8-week intervention that consists of a set of breathing practices through 60-minute weekly group on-site sessions (1day/week) with a 20-minute daily home sessions (in between on-site sessions; 6 days/week). |
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| Breathing Group 2 | Active Comparator | Arm 2 will receive an 8-week intervention that consists of slow breathing practices through 60-minute weekly group on-site sessions (1day/week) with a 20-minute daily home sessions (in between on-site sessions; 6 days/week). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathing Group 1 | Behavioral | The 8-week breathwork intervention incorporates a set of breathing practices under the guidance of a certified yoga teacher. |
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| Measure | Description | Time Frame |
|---|---|---|
| CSF Flow Velocities | We have collected cerebrospinal fluid (CSF) flow measurements during a set of breathing practices while subjects were inside the MRI scanner. MRI-based CSF flow was quantified at the level of Foramen Magnum. Data processing included the extraction of velocity waveforms of the CSF motion ( i.e, CSF velocity in cm/s) and subsequent analysis of CSF velocities across different breathing conditions. Positive CSF velocities indicate fluid motion in the cranial (upward) direction, whereas negative velocities represent fluid motion in the caudal (downward) direction. For the registry, descriptive statistics of CSF velocities (mean and standard deviation) are reported at pre- and post-intervention for participants completing both MRI visits with analyzable CSF data (Group 1 n=7, Group 2 n=7). No inferential statistical tests or change score analyses are included in the registry submission; all reported results are descriptive only. | Baseline (pre-intervention) and post-intervention (after 8 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic and Diastolic Blood Pressure | Systolic and diastolic blood pressure were measured participants seated at rest at pre- and post-intervention visits. | Baseline (pre-intervention) and post-intervention (after 8 weeks). |
| Body Mass Index (BMI) |
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Inclusion Criteria:
- 18-65 years of age, able to provide their consent to be in the study, available and able to participate in study activities, who can lie in supine, able to walk 15 feet, who have no prior/current mind-body practice inducing breath awareness or training such as yoga, meditation, Ta-Chi, Qi-Gong.
Exclusion Criteria:
- Inability to provide informed consent, MRI contraindications, need for muscle relaxants or anti-anxiety drugs in order to tolerate MRI, history of neurological disorders, head trauma with loss of consciousness, craniospinal disorders, spinal injury, sleep disorders, allergic or respiratory disorders, major or uncontrolled psychiatric illness or major depression, lung and heart problems, any condition requiring the use of medication that acts on the brain like stimulants, sedatives current substance abuse issues, pregnancy or nursing.
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| Name | Affiliation | Role |
|---|---|---|
| Yildiz | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Breathing Group 1 | Arm 1 will receive an 8-week intervention that consists of a set of breathing practices through 60-minute weekly group on-site sessions (1day/week) with a 20-minute daily home sessions (in between on-site sessions; 6 days/week). Breathing Group 1: The 8-week breathwork intervention incorporates a set of breathing practices under the guidance of a certified yoga teacher. |
| FG001 | Breathing Group 2 | Arm 2 will receive an 8-week intervention that consists of slow breathing practices through 60-minute weekly group on-site sessions (1day/week) with a 20-minute daily home sessions (in between on-site sessions; 6 days/week). Breathing Group 2: The 8-week breathwork intervention incorporates a set of slow breathing practices under the guidance of a certified yoga teacher. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The baseline analysis population included all 21 participants who completed enrollment and provided pre-intervention data (Active n=11, Control n=10). These participants are represented in the baseline characteristics table.
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| ID | Title | Description |
|---|---|---|
| BG000 | Breathing Group 1 | Arm 1 will receive an 8-week intervention that consists of a set of breathing practices through 60-minute weekly group on-site sessions (1day/week) with a 20-minute daily home sessions (in between on-site sessions; 6 days/week). Breathing Group 1: The 8-week breathwork intervention incorporates a set of breathing practices under the guidance of a certified yoga teacher. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CSF Flow Velocities | We have collected cerebrospinal fluid (CSF) flow measurements during a set of breathing practices while subjects were inside the MRI scanner. MRI-based CSF flow was quantified at the level of Foramen Magnum. Data processing included the extraction of velocity waveforms of the CSF motion ( i.e, CSF velocity in cm/s) and subsequent analysis of CSF velocities across different breathing conditions. Positive CSF velocities indicate fluid motion in the cranial (upward) direction, whereas negative velocities represent fluid motion in the caudal (downward) direction. For the registry, descriptive statistics of CSF velocities (mean and standard deviation) are reported at pre- and post-intervention for participants completing both MRI visits with analyzable CSF data (Group 1 n=7, Group 2 n=7). No inferential statistical tests or change score analyses are included in the registry submission; all reported results are descriptive only. | The analysis population included participants who completed both MRI visits and had analyzable CSF flow data (n=14; Group 1=7, Group 2=7). Pre- and post-intervention peak CSF velocities (maximum cranially directed and minimum caudally directed) during breathing practices were summarized in absolute units (cm/s) as mean and standard deviation. | Posted | Mean | Standard Deviation | cm/s | Baseline (pre-intervention) and post-intervention (after 8 weeks). |
12 weeks per participant ( 2-week-pre intervention, 8-week intervention, and 2-week post-intervention).
The study were to record all reportable events by study staff and through participant self-report from baseline through 2 weeks after completion of the 8-week intervention, for a total monitoring period of 12 weeks per participant (including 2-week pre-intervention, 8-week intervention, and 2-week post-intervention).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Breathing Group 1 | Arm 1 will receive an 8-week intervention that consists of a set of breathing practices through 60-minute weekly group on-site sessions (1day/week) with a 20-minute daily home sessions (in between on-site sessions; 6 days/week). Breathing Group 1: The 8-week breathwork intervention incorporates a set of breathing practices under the guidance of a certified yoga teacher. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Selda Yildiz, PhD | Oregon Health & Science University (OHSU) | (503) 494-7219 | yildiz@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2019 | Apr 1, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| D007040 | Hypoventilation |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Breathing Group 2 | Behavioral | The 8-week breathwork intervention incorporates a set of slow breathing practices under the guidance of a certified yoga teacher. |
|
BMI was collected at pre- and post-intervention visits, and was calculated as weight in kilograms divided by height in meters squared (kg/m²).
| Baseline (pre-intervention) and post-intervention (after 8 weeks). |
| Daily Home Practice Frequency | Average breathing practice frequency were measured using a wearable respiration tracker to objectively evaluate home practice throughout the intervention: frequency (days/week). Preliminary analysis estimated mean frequency (days/week) across participants. Onsite class sessions were excluded. | 8 weeks (daily home practice over the course of 8-week intervention). |
| Daily Home Practice Duration | Average breathing practice duration were measured using a wearable respiration tracker to objectively evaluate home practice throughout the intervention: duration (in minute). Preliminary analysis estimated mean duration (minutes) across participants. Onsite class sessions were excluded. | 8 weeks (daily home practice over the course of 8-week intervention). |
| BG001 | Breathing Group 2 | Arm 2 will receive an 8-week intervention that consists of slow breathing practices through 60-minute weekly group on-site sessions (1day/week) with a 20-minute daily home sessions (in between on-site sessions; 6 days/week). Breathing Group 2: The 8-week breathwork intervention incorporates a set of slow breathing practices under the guidance of a certified yoga teacher. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
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| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Secondary | Systolic and Diastolic Blood Pressure | Systolic and diastolic blood pressure were measured participants seated at rest at pre- and post-intervention visits. | Participants who completed both pre- and post-intervention visits and had systolic/diastolic blood pressure data collected at both time points. | Posted | Mean | Standard Deviation | mmHg | Baseline (pre-intervention) and post-intervention (after 8 weeks). |
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| Secondary | Body Mass Index (BMI) | BMI was collected at pre- and post-intervention visits, and was calculated as weight in kilograms divided by height in meters squared (kg/m²). | The analysis population for BMI included participants who completed both pre- and post-intervention visits and had weight and height data collected at both time points. | Posted | Mean | Standard Deviation | kg/m² | Baseline (pre-intervention) and post-intervention (after 8 weeks). |
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| Secondary | Daily Home Practice Frequency | Average breathing practice frequency were measured using a wearable respiration tracker to objectively evaluate home practice throughout the intervention: frequency (days/week). Preliminary analysis estimated mean frequency (days/week) across participants. Onsite class sessions were excluded. | Twelve participants (6 in each group) who completed the 8-week intervention and had usable respiration tracker data. Participants without trackers or with missing data due to technical issues were excluded. | Posted | Mean | Standard Deviation | days/week | 8 weeks (daily home practice over the course of 8-week intervention). |
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| Secondary | Daily Home Practice Duration | Average breathing practice duration were measured using a wearable respiration tracker to objectively evaluate home practice throughout the intervention: duration (in minute). Preliminary analysis estimated mean duration (minutes) across participants. Onsite class sessions were excluded. | Twelve participants (6 in each group) who completed the 8-week intervention and had usable respiration tracker data. Participants without trackers or with missing data due to technical issues were excluded. | Posted | Mean | Standard Deviation | minute | 8 weeks (daily home practice over the course of 8-week intervention). |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Breathing Group 2 | Arm 2 will receive an 8-week intervention that consists of slow breathing practices through 60-minute weekly group on-site sessions (1day/week) with a 20-minute daily home sessions (in between on-site sessions; 6 days/week). Breathing Group 2: The 8-week breathwork intervention incorporates a set of slow breathing practices under the guidance of a certified yoga teacher. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D012131 | Respiratory Insufficiency |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| Post-intervention systolic blood pressure |
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| Pre-intervention diastolic blood pressure |
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| Post-intervention diastolic blood pressure |
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