CSF Circulation
Conditions
Keywords
Cerebrospinal Fluid, Cerebrospinal Fluid Flow, Cerebrospinal Fluid Circulation, Yoga, Yogic Breathwork, Magnetic Resonance Imaging, Breathing, Sleep, RT-PCMRI, CSF Flow, Slow Breathing, Respiration
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBreathing Group 1
The 8-week breathwork intervention incorporates a set of breathing practices under the guidance of a certified yoga teacher.
BEHAVIORALBreathing Group 2
The 8-week breathwork intervention incorporates a set of slow breathing practices under the guidance of a certified yoga teacher.
Sponsors
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CSF Flow Velocities | Baseline (pre-intervention) and post-intervention (after 8 weeks). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic and Diastolic Blood Pressure | Baseline (pre-intervention) and post-intervention (after 8 weeks). | Systolic and diastolic blood pressure were measured participants seated at rest at pre- and post-intervention visits. |
| Body Mass Index (BMI) | Baseline (pre-intervention) and post-intervention (after 8 weeks). | BMI was collected at pre- and post-intervention visits, and was calculated as weight in kilograms divided by height in meters squared (kg/m²). |
| Daily Home Practice Frequency | 8 weeks (daily home practice over the course of 8-week intervention). | 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. |
| Daily Home Practice Duration | 8 weeks (daily home practice over the course of 8-week intervention). | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| 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. | 10 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Breathing Group 1 | Breathing Group 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 10 Participants | 21 Participants |
| Age, Continuous | 35.09 Years STANDARD_DEVIATION 14.46 | 34.00 Years STANDARD_DEVIATION 14.05 | 34.57 Years STANDARD_DEVIATION 13.92 |
| Body Mass Index (BMI) | 25.15 kg/m² STANDARD_DEVIATION 4.62 | 25.89 kg/m² STANDARD_DEVIATION 5.23 | 25.50 kg/m² STANDARD_DEVIATION 4.81 |
| Diastolic Blood Pressure | 78.09 mmHg STANDARD_DEVIATION 11.95 | 68.60 mmHg STANDARD_DEVIATION 13.18 | 73.57 mmHg STANDARD_DEVIATION 13.16 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 7 Participants | 5 Participants | 12 Participants |
| Region of Enrollment United States | 11 participants | 10 participants | 21 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
| Systolic Blood Pressure | 126.45 mmHg STANDARD_DEVIATION 14.87 | 122.70 mmHg STANDARD_DEVIATION 21.23 | 124.67 mmHg STANDARD_DEVIATION 17.81 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 0 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 |
Outcome results
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.
Time frame: Baseline (pre-intervention) and post-intervention (after 8 weeks).
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Breathing Group 1 | CSF Flow Velocities | Post-intervention maximum (cranially directed) CSF velocity during deep abdominal breathing | 1.79 cm/s | Standard Deviation 0.57 |
| Breathing Group 1 | CSF Flow Velocities | Pre-intervention minimum (caudally directed) CSF velocity during natural breathing | -1.92 cm/s | Standard Deviation 0.51 |
| Breathing Group 1 | CSF Flow Velocities | Pre-intervention minimum (caudally directed) CSF velocity during deep abdominal breathing | -2.12 cm/s | Standard Deviation 0.61 |
| Breathing Group 1 | CSF Flow Velocities | Post-intervention maximum (cranially directed) CSF velocity during slow breathing | 1.56 cm/s | Standard Deviation 0.45 |
| Breathing Group 1 | CSF Flow Velocities | Post-intervention minimum (caudally directed) CSF velocity during deep abdominal breathing | -1.90 cm/s | Standard Deviation 0.47 |
| Breathing Group 1 | CSF Flow Velocities | Post-intervention maximum (cranially directed) CSF velocity during natural breathing | 1.48 cm/s | Standard Deviation 0.42 |
| Breathing Group 1 | CSF Flow Velocities | Pre-intervention maximum (cranially directed) CSF velocity during deep diaphragmatic breathing | 1.88 cm/s | Standard Deviation 0.38 |
| Breathing Group 1 | CSF Flow Velocities | Post-intervention maximum (cranially directed) CSF velocity during deep diaphragmatic breathing | 1.61 cm/s | Standard Deviation 0.58 |
| Breathing Group 1 | CSF Flow Velocities | Pre-intervention minimum (caudally directed) CSF velocity during slow breathing | -2.15 cm/s | Standard Deviation 0.63 |
| Breathing Group 1 | CSF Flow Velocities | Pre-intervention minimum (caudally directed) CSF velocity during deep diaphragmatic breathing | -2.14 cm/s | Standard Deviation 0.61 |
| Breathing Group 1 | CSF Flow Velocities | Post-intervention minimum (caudally directed) CSF velocity during natural breathing | -1.68 cm/s | Standard Deviation 0.47 |
| Breathing Group 1 | CSF Flow Velocities | Post-intervention minimum (caudally directed) CSF velocity during deep diaphragmatic breathing | -1.97 cm/s | Standard Deviation 0.256 |
| Breathing Group 1 | CSF Flow Velocities | Pre-intervention maximum (cranially directed) CSF velocity during deep chest breathing | 2.02 cm/s | Standard Deviation 0.62 |
| Breathing Group 1 | CSF Flow Velocities | Post-intervention minimum (caudally directed) CSF velocity during slow breathing | -1.80 cm/s | Standard Deviation 0.37 |
| Breathing Group 1 | CSF Flow Velocities | Post-intervention maximum (cranially directed) CSF velocity during deep chest breathing | 1.58 cm/s | Standard Deviation 0.45 |
| Breathing Group 1 | CSF Flow Velocities | Pre-intervention maximum (cranially directed) CSF velocity during natural breathing | 1.36 cm/s | Standard Deviation 0.27 |
| Breathing Group 1 | CSF Flow Velocities | Pre-intervention minimum (caudally directed) CSF velocity during deep chest breathing | -2.03 cm/s | Standard Deviation 0.42 |
| Breathing Group 1 | CSF Flow Velocities | Pre-intervention maximum (cranially directed) CSF velocity during deep abdominal breathing | 2.02 cm/s | Standard Deviation 0.64 |
| Breathing Group 1 | CSF Flow Velocities | Post-intervention minimum (caudally directed) CSF velocity during deep chest breathing | -1.74 cm/s | Standard Deviation 0.54 |
| Breathing Group 1 | CSF Flow Velocities | Pre-intervention maximum (cranially directed) CSF velocity during slow breathing | 1.76 cm/s | Standard Deviation 0.62 |
| Breathing Group 2 | CSF Flow Velocities | Post-intervention minimum (caudally directed) CSF velocity during deep chest breathing | -1.77 cm/s | Standard Deviation 0.53 |
| Breathing Group 2 | CSF Flow Velocities | Post-intervention minimum (caudally directed) CSF velocity during deep diaphragmatic breathing | -1.80 cm/s | Standard Deviation 0.46 |
| Breathing Group 2 | CSF Flow Velocities | Pre-intervention maximum (cranially directed) CSF velocity during natural breathing | 1.31 cm/s | Standard Deviation 0.23 |
| Breathing Group 2 | CSF Flow Velocities | Post-intervention maximum (cranially directed) CSF velocity during natural breathing | 1.15 cm/s | Standard Deviation 0.25 |
| Breathing Group 2 | CSF Flow Velocities | Pre-intervention minimum (caudally directed) CSF velocity during natural breathing | -1.73 cm/s | Standard Deviation 0.41 |
| Breathing Group 2 | CSF Flow Velocities | Post-intervention minimum (caudally directed) CSF velocity during natural breathing | -1.84 cm/s | Standard Deviation 0.45 |
| Breathing Group 2 | CSF Flow Velocities | Pre-intervention maximum (cranially directed) CSF velocity during slow breathing | 1.48 cm/s | Standard Deviation 0.37 |
| Breathing Group 2 | CSF Flow Velocities | Post-intervention maximum (cranially directed) CSF velocity during slow breathing | 1.35 cm/s | Standard Deviation 0.43 |
| Breathing Group 2 | CSF Flow Velocities | Pre-intervention minimum (caudally directed) CSF velocity during slow breathing | -1.68 cm/s | Standard Deviation 0.48 |
| Breathing Group 2 | CSF Flow Velocities | Post-intervention minimum (caudally directed) CSF velocity during slow breathing | -1.94 cm/s | Standard Deviation 0.66 |
| Breathing Group 2 | CSF Flow Velocities | Pre-intervention maximum (cranially directed) CSF velocity during deep abdominal breathing | 1.64 cm/s | Standard Deviation 0.43 |
| Breathing Group 2 | CSF Flow Velocities | Post-intervention maximum (cranially directed) CSF velocity during deep abdominal breathing | 1.43 cm/s | Standard Deviation 0.37 |
| Breathing Group 2 | CSF Flow Velocities | Pre-intervention minimum (caudally directed) CSF velocity during deep abdominal breathing | -1.68 cm/s | Standard Deviation 0.47 |
| Breathing Group 2 | CSF Flow Velocities | Post-intervention minimum (caudally directed) CSF velocity during deep abdominal breathing | -1.75 cm/s | Standard Deviation 0.55 |
| Breathing Group 2 | CSF Flow Velocities | Post-intervention maximum (cranially directed) CSF velocity during deep diaphragmatic breathing | 1.42 cm/s | Standard Deviation 0.33 |
| Breathing Group 2 | CSF Flow Velocities | Pre-intervention minimum (caudally directed) CSF velocity during deep diaphragmatic breathing | -2.23 cm/s | Standard Deviation 1.32 |
| Breathing Group 2 | CSF Flow Velocities | Pre-intervention maximum (cranially directed) CSF velocity during deep chest breathing | 1.49 cm/s | Standard Deviation 0.47 |
| Breathing Group 2 | CSF Flow Velocities | Post-intervention maximum (cranially directed) CSF velocity during deep chest breathing | 1.51 cm/s | Standard Deviation 0.44 |
| Breathing Group 2 | CSF Flow Velocities | Pre-intervention minimum (caudally directed) CSF velocity during deep chest breathing | -1.73 cm/s | Standard Deviation 0.56 |
| Breathing Group 2 | CSF Flow Velocities | Pre-intervention maximum (cranially directed) CSF velocity during deep diaphragmatic breathing | 2.00 cm/s | Standard Deviation 1.31 |
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).
Time frame: Baseline (pre-intervention) and post-intervention (after 8 weeks).
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Breathing Group 1 | Body Mass Index (BMI) | Pre-Intervention BMI | 25.33 kg/m² | Standard Deviation 1.66 |
| Breathing Group 1 | Body Mass Index (BMI) | Post-Intervention BMI | 25.16 kg/m² | Standard Deviation 1.57 |
| Breathing Group 2 | Body Mass Index (BMI) | Pre-Intervention BMI | 24.33 kg/m² | Standard Deviation 1.56 |
| Breathing Group 2 | Body Mass Index (BMI) | Post-Intervention BMI | 24.46 kg/m² | Standard Deviation 1.56 |
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.
Time frame: 8 weeks (daily home practice over the course of 8-week intervention).
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breathing Group 1 | Daily Home Practice Duration | 21.80 minute | Standard Deviation 2.27 |
| Breathing Group 2 | Daily Home Practice Duration | 20.22 minute | Standard Deviation 0.54 |
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.
Time frame: 8 weeks (daily home practice over the course of 8-week intervention).
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breathing Group 1 | Daily Home Practice Frequency | 5.00 days/week | Standard Deviation 0.82 |
| Breathing Group 2 | Daily Home Practice Frequency | 5.43 days/week | Standard Deviation 0.8 |
Secondary
Systolic and Diastolic Blood Pressure
Systolic and diastolic blood pressure were measured participants seated at rest at pre- and post-intervention visits.
Time frame: Baseline (pre-intervention) and post-intervention (after 8 weeks).
Population: Participants who completed both pre- and post-intervention visits and had systolic/diastolic blood pressure data collected at both time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Breathing Group 1 | Systolic and Diastolic Blood Pressure | Pre-intervention systolic blood pressure | 128.11 mmHg | Standard Deviation 16.07 |
| Breathing Group 1 | Systolic and Diastolic Blood Pressure | Post-intervention systolic blood pressure | 125.62 mmHg | Standard Deviation 4.55 |
| Breathing Group 1 | Systolic and Diastolic Blood Pressure | Pre-intervention diastolic blood pressure | 80.22 mmHg | Standard Deviation 4.08 |
| Breathing Group 1 | Systolic and Diastolic Blood Pressure | Post-intervention diastolic blood pressure | 76.00 mmHg | Standard Deviation 3.46 |
| Breathing Group 2 | Systolic and Diastolic Blood Pressure | Post-intervention diastolic blood pressure | 63.43 mmHg | Standard Deviation 4.15 |
| Breathing Group 2 | Systolic and Diastolic Blood Pressure | Pre-intervention systolic blood pressure | 117.71 mmHg | Standard Deviation 7.99 |
| Breathing Group 2 | Systolic and Diastolic Blood Pressure | Pre-intervention diastolic blood pressure | 66.29 mmHg | Standard Deviation 4.15 |
| Breathing Group 2 | Systolic and Diastolic Blood Pressure | Post-intervention systolic blood pressure | 118.29 mmHg | Standard Deviation 7.99 |