An interventional study of Slow Breathing in Spinal Cord Injuries and Slow Breathing, sponsored by Spaulding Rehabilitation Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Spaulding Rehabilitation Hospital · Not applicable, Interventional, and Supportive care
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's enrollment of 17 is below the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Spaulding Rehabilitation Hospital is the lead sponsor of 117 studies on the registry; 27 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 17 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Slow Breathing
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: 1. frequency (between 0.25 and 0.1 Hz) 2. Inspiratory:Expiratory (I:E) ratio or 'Duty Cycle' 3. with and without ujjayi (yogic throat restriction) 4. with and without inspiratory/expiratory breath holding 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.
Also known as: Yogic-Derived Breathing
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.
Time frame: 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.
Time frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14
SpO2
Peripheral oxygen saturation during paced or unpaced breathing
Time frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14
Expired Carbon Dioxide (CO2)
Expired CO2 from a nasal cannula
Time frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14
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.
| Milestone | Spinal Cord Injury |
|---|---|
| Started | 17 |
| Completed | 12 |
| Not completed | 5 |
| Milestone | Spinal Cord Injury |
|---|---|
| Started | 12 |
| Unpaced breathing | 12 |
| 0.25 hz breathing | 12 |
| 0.083 hz breathing | 12 |
| Box breathing | 12 |
| Extended exhale breathing | 12 |
| Ujjayi breathing | 12 |
| Completed | 12 |
| Not completed | 0 |
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.
| ms^2 | Unpaced Breathing | 0.25 Hz Breathing | 0.083 Hz Breathing | Box Breathing | Extended Exhale Breathing | Ujjayi Breathing |
|---|---|---|---|---|---|---|
| Low Frequency R-R Interval Power (0.04-15 Hz) | 1421 ± 412 | 813 ± 307 | 3173 ± 913 | 2819 ± 681 | 4008 ± 969 | 5490 ± 1465 |
| High Frequency R-R Interval Power(0.15-40 Hz) | 756 ± 247 | 802 ± 304 | 477 ± 203 | 722 ± 234 | 897 ± 378 | 759 ± 468 |
| Total R-R interval Power (0.04 - 0.40 Hz) | 2177 ± 637 | 1615 ± 496 | 3650 ± 1042 | 3590 ± 848 | 4905 ± 1159 | 6249 ± 1854 |
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.
| mmHg^2 | Unpaced Breathing | 0.25 Hz Breathing | 0.083 Hz Breathing | Box Breathing | Extended Exhale Breathing | Ujjayi Breathing |
|---|---|---|---|---|---|---|
| Low Frequency Systolic Blood Pressure Power (0.04 - 1.5 Hz) | 2.6 ± 0.7 | 1.4 ± 0.5 | 6.1 ± 1.8 | 7.6 ± 1.7 | 6.9 ± 1.4 | 15.1 ± 4.0 |
| High Frequency Systolic Blood Pressure Power(0.15 - 0.40 Hz) | 1.2 ± 0.2 | 1.5 ± 0.4 | 0.7 ± 0.2 | 2.5 ± 0.5 | 0.9 ± 0.2 | 1.7 ± 0.7 |
| Total Systolic Blood Pressure Power(0.04 - 0.40 Hz) | 3.8 ± 0.8 | 2.8 ± 0.7 | 6.8 ± 1.8 | 10.2 ± 1.7 | 7.8 ± 1.4 | 16.8 ± 4 |
Peripheral oxygen saturation during paced or unpaced breathing
| % O2 satuation | Unpaced Breathing | 0.25 Hz Breathing | 0.083 Hz Breathing | Box Breathing | Extended Exhale Breathing | Ujjayi Breathing |
|---|---|---|---|---|---|---|
| SpO2 | 96.1 ± 0.6 | 96.9 ± 0.5 | 97.2 ± 0.3 | 96.6 ± 0.5 | 96.7 ± 0.4 | 97.6 ± 0.3 |
Expired CO2 from a nasal cannula
| mmHg | Unpaced Breathing | 0.25 Hz Breathing | 0.083 Hz Breathing | Box Breathing | Extended Exhale Breathing | Ujjayi Breathing |
|---|---|---|---|---|---|---|
| Expired Carbon Dioxide (CO2) | 35 ± 1 | 31 ± 1 | 36 ± 1 | 37 ± 1 | 36 ± 1 | 32 ± 2 |
Collected over From enrollment until end of study visit, up to 2 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Spinal Cord Injury | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Continuous(Years) | Spinal Cord Injury |
|---|---|
| Mean | 33.25 ± 5.97 |
| Sex: Female, Male(Participants) | Spinal Cord Injury |
|---|---|
| Female | 3 |
| Male | 9 |
| Race (NIH/OMB)(Participants) | Spinal Cord Injury |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Ethnicity (NIH/OMB)(Participants) | Spinal Cord Injury |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 11 |
| Unknown or Not Reported | 0 |
| Body Mass Index(kg/m^2) | Spinal Cord Injury |
|---|---|
| Mean | 26.2 ± 4.9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2022 to primary completion in Jan 2024, 16 months.
Results were first posted in Apr 2026, 2 years 3 months after primary completion.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's 16 months is below that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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