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This research will aid in understanding of slow-breathing and its effect on heart rate and blood pressure in people with a spinal cord injury (SCI). This research will investigate if traditional 'yogic' breathing exercises can be performed by subjects with SCI and its influence on the cardiovascular system.
The relationship between respiratory patterns and cardiovascular variability in healthy persons has been previously studied. However, the impact of SCI on the interrelationships between the respiratory and cardiovascular systems remains relatively unstudied. The loss of autonomic control in SCI may mean that slow breathing has profound effects on cardiovascular variability. Hence, those with SCI may represent a population that could benefit from the potential physiologic effects of numerous yogic-based breathing patterns that can be applied anywhere any time. Hence, it is important to determine if slower breathing patterns can shift the cardiovascular control pattern to-wards important healthful effects. This physiological study will compare the effects of uncontrolled breathing and traditional yogic slow-breathing practices on cardiovascular variability in SCI patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Cord Injured Participants | Experimental | 17 medically stable male and female subjects between 18 and 60 years old, BMI between 18.5-35 kg/m2, with a SCI and who use a wheelchair were recruited. Participants that did not speak English or with a history of renal, neurological, or coronary artery disease, cancer, diabetes, significant arrhythmia smoking, or using cardioactive medications were excluded. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Slow Breathing | Behavioral | On two separate visits (on Day 1 and between Day 7 and 9 of their self-practice) the subject will be coached on yoga breathing techniques. The breathing techniques will be varied in:
At the end of the first coaching visit the subject will be given a diary to record their own practice of the breathing techniques they were coached on. |
| Measure | Description | Time Frame |
|---|---|---|
| HRV | Heart rate variability assessed in the frequency domain during paced or unpaced breathing via Welch's modified periodogram method. Average power calculated by integrating the power spectral density in the low and high frequency bands. | 7 minutes of paced or unpaced breathing at single study visit on Day 14 |
| BPV | Systolic blood pressure variability from a Finometer assessed in the frequency domain via Welch's modified periodogram method. Average power calculated by integrating the power spectral density in the low and high frequency bands. | 7 minutes of paced or unpaced breathing at single study visit on Day 14 |
| SpO2 | Peripheral oxygen saturation during paced or unpaced breathing | 7 minutes of paced or unpaced breathing at single study visit on Day 14 |
| Expired Carbon Dioxide (CO2) | Expired CO2 from a nasal cannula | 7 minutes of paced or unpaced breathing at single study visit on Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Cambridge | Massachusetts | 02138 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38507692 | Derived | Mazur MD, Hamner JW, Anand AN, Taylor JA. Cardiorespiratory Effects of Yogic Versus Slow Breathing in Individuals with a Spinal Cord Injury: An Exploratory Cohort Study. J Integr Complement Med. 2024 Sep;30(9):878-885. doi: 10.1089/jicm.2023.0641. Epub 2024 Mar 20. |
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17 individuals signed an informed consent. 12 completed a study visit. All breathing patterns/milestones were completed by the 12 individuals who completed the study.
All participants had a spinal cord injury and were wheelchair users. After screening and signing an informed consent, participants receive instruction on how to perform the different breathing patterns (milestones/rows). After 2 instructional sessions and 2 weeks of practice on their own a study visit was scheduled. Participants completed all breathing patterns in a random order in a single study visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spinal Cord Injury | Individuals with a spinal cord injury. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Breathing Familiarization (2 weeks) |
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| Study Visit |
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| ID | Title | Description |
|---|---|---|
| BG000 | Spinal Cord Injury | Individuals with a spinal cord injury who completed the study visit. |
| 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, Continuous | Mean |
| 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 | HRV | Heart rate variability assessed in the frequency domain during paced or unpaced breathing via Welch's modified periodogram method. Average power calculated by integrating the power spectral density in the low and high frequency bands. | Repeated measures in 12 individuals during 1 study visit | Posted | Mean | Standard Error | ms^2 | 7 minutes of paced or unpaced breathing at single study visit on Day 14 |
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From enrollment until end of study visit, up to 2 weeks.
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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 | Spinal Cord Injury | Individuals with a spinal cord injury. | 0 |
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This exploratory study had a limited sample size, consisting of only 12 participants and specific exclusion criteria, certain medical histories, smoking, and use of cardioactive medications potentially which may restrict the generalizability of the results. The recruitment strategy from a single rehabilitation hospital program may introduce selection bias, limiting the diversity of the sample and potentially impacting the external validity of the findings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Andrew Taylor | Spaulding Hospital Cambridge | 617-753-5503 | jandrew_taylor@hms.harvard.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 | May 19, 2023 | Mar 10, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D007040 | Hypoventilation |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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This study was a small prospective cohort (N = 12 out of 17 completed) study with a one-time unblinded intervention of 4 differing breathing techniques/ratios compared to spontaneous breathing. Patients will receive instruction on D1 and on D7 lasting about 45 minutes and a diary for self-practice. On D14 the participant will be asked to sequentially perform the directed breathing frequencies and ratios. The lab visit will last approximately 1.5 hours, during which beat-by-beat cardiovascular variables and breath-by-breath respiratory variables will be recorded. The total in-person time commitment (~4 hours) over the 14 days.
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|
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| 0.083 Hz Breathing |
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| Box Breathing |
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| Extended Exhale Breathing |
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| Ujjayi Breathing |
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| COMPLETED |
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| NOT COMPLETED |
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| 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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| OG002 | 0.083 Hz Breathing | Frequency: 0.083 Hz Duty Cycle: 6 second inhale; 6 second exhale |
| OG003 | Box Breathing | Frequency: 0.083 Hz. Duty Cycle: 3 second inhale; 3 second hold: 3 second exhale: 3 second hold. |
| OG004 | Extended Exhale Breathing | Frequency: 0.083 Hz Duty Cycle: 4 sec Inhale: 8 sec exhale |
| OG005 | Ujjayi Breathing | Frequency: 0.083 Hz Duty Cycle: 6 sec Inhale: 6 sec exhale with throat resistance |
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|
| Primary | BPV | Systolic blood pressure variability from a Finometer assessed in the frequency domain via Welch's modified periodogram method. Average power calculated by integrating the power spectral density in the low and high frequency bands. | Repeated measures in the same 12 participants in 1 study visit. | Posted | Mean | Standard Error | mmHg^2 | 7 minutes of paced or unpaced breathing at single study visit on Day 14 |
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| Primary | SpO2 | Peripheral oxygen saturation during paced or unpaced breathing | Repeated measures in 12 participants made in 1 study visit. | Posted | Mean | Standard Error | % O2 satuation | 7 minutes of paced or unpaced breathing at single study visit on Day 14 |
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| Primary | Expired Carbon Dioxide (CO2) | Expired CO2 from a nasal cannula | Repeated measurements in 12 participants made during 1 study visit. | Posted | Mean | Standard Error | mmHg | 7 minutes of paced or unpaced breathing at single study visit on Day 14 |
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| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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| D014947 | Wounds and Injuries |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| High Frequency Systolic Blood Pressure Power(0.15 - 0.40 Hz) |
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| Total Systolic Blood Pressure Power(0.04 - 0.40 Hz) |
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