Trial Outcomes & Findings for Slow Yogic-Derived Breathing and Respiration and Cardiovascular Variability in Spinal Cord Injury Patients (NCT NCT05480618)
NCT ID: NCT05480618
Last Updated: 2026-04-28
Results Overview
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.
COMPLETED
NA
17 participants
7 minutes of paced or unpaced breathing
2026-04-28
Participant Flow
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 (arms). After 2 instructional sessions and 2 weeks of practice on their own a study visit was scheduled. Participants completed all arms in a random order in a single study visit.
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.
Participant milestones
| Measure |
Spinal Cord Injury
Individuals with a spinal cord injury.
|
|---|---|
|
Breathing Familiarization (2 weeks)
STARTED
|
17
|
|
Breathing Familiarization (2 weeks)
COMPLETED
|
12
|
|
Breathing Familiarization (2 weeks)
NOT COMPLETED
|
5
|
|
Study Visit
STARTED
|
12
|
|
Study Visit
Unpaced Breathing
|
12
|
|
Study Visit
0.25 Hz Breathing
|
12
|
|
Study Visit
0.083 Hz Breathing
|
12
|
|
Study Visit
Box Breathing
|
12
|
|
Study Visit
Extended Exhale Breathing
|
12
|
|
Study Visit
Ujjayi Breathing
|
12
|
|
Study Visit
COMPLETED
|
12
|
|
Study Visit
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Slow Yogic-Derived Breathing and Respiration and Cardiovascular Variability in Spinal Cord Injury Patients
Baseline characteristics by cohort
| Measure |
Spinal Cord Injury
n=12 Participants
Individuals with a spinal cord injury who completed the study visit.
|
|---|---|
|
Age, Continuous
|
33.25 Years
STANDARD_DEVIATION 5.97 • n=9 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Body Mass Index
|
26.2 kg/m^2
STANDARD_DEVIATION 4.9 • n=9 Participants
|
PRIMARY outcome
Timeframe: 7 minutes of paced or unpaced breathingPopulation: Repeated measures in 12 individuals during 1 study visit
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.
Outcome measures
| Measure |
0.083 Hz Breathing
n=12 Participants
Frequency: 0.083 Hz Duty Cycle: 6 second inhale; 6 second exhale
|
Box Breathing
n=12 Participants
Frequency: 0.083 Hz. Duty Cycle: 3 second inhale; 3 second hold: 3 second exhale: 3 second hold.
|
Extended Exhale Breathing
n=12 Participants
Frequency: 0.083 Hz Duty Cycle: 4 sec Inhale: 8 sec exhale
|
Ujjayi Breathing
n=12 Participants
Frequency: 0.083 Hz Duty Cycle: 6 sec Inhale: 6 sec exhale with throat resistance
|
Unpaced Breathing
n=12 Participants
Frequency: Variable Duty Cycle: Variable
|
0.25 Hz Breathing
n=12 Participants
Frequency: 0.25 Hz Duty Cycle: 2 second inhale: 2 second exhale
|
|---|---|---|---|---|---|---|
|
HRV
Low Frequency R-R Interval Power (0.04-15 Hz)
|
3173 ms^2
Standard Error 913
|
2819 ms^2
Standard Error 681
|
4008 ms^2
Standard Error 969
|
5490 ms^2
Standard Error 1465
|
1421 ms^2
Standard Error 412
|
813 ms^2
Standard Error 307
|
|
HRV
High Frequency R-R Interval Power(0.15-40 Hz)
|
477 ms^2
Standard Error 203
|
722 ms^2
Standard Error 234
|
897 ms^2
Standard Error 378
|
759 ms^2
Standard Error 468
|
756 ms^2
Standard Error 247
|
802 ms^2
Standard Error 304
|
|
HRV
Total R-R interval Power (0.04 - 0.40 Hz)
|
3650 ms^2
Standard Error 1042
|
3590 ms^2
Standard Error 848
|
4905 ms^2
Standard Error 1159
|
6249 ms^2
Standard Error 1854
|
2177 ms^2
Standard Error 637
|
1615 ms^2
Standard Error 496
|
PRIMARY outcome
Timeframe: 7 minutes of paced or unpaced breathingPopulation: Repeated measures in the same 12 participants in 1 study visit.
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.
Outcome measures
| Measure |
0.083 Hz Breathing
n=12 Participants
Frequency: 0.083 Hz Duty Cycle: 6 second inhale; 6 second exhale
|
Box Breathing
n=12 Participants
Frequency: 0.083 Hz. Duty Cycle: 3 second inhale; 3 second hold: 3 second exhale: 3 second hold.
|
Extended Exhale Breathing
n=12 Participants
Frequency: 0.083 Hz Duty Cycle: 4 sec Inhale: 8 sec exhale
|
Ujjayi Breathing
n=12 Participants
Frequency: 0.083 Hz Duty Cycle: 6 sec Inhale: 6 sec exhale with throat resistance
|
Unpaced Breathing
n=12 Participants
Frequency: Variable Duty Cycle: Variable
|
0.25 Hz Breathing
n=12 Participants
Frequency: 0.25 Hz Duty Cycle: 2 second inhale: 2 second exhale
|
|---|---|---|---|---|---|---|
|
BPV
Low Frequency Systolic Blood Pressure Power (0.04 - 1.5 Hz)
|
6.1 mmHg^2
Standard Error 1.8
|
7.6 mmHg^2
Standard Error 1.7
|
6.9 mmHg^2
Standard Error 1.4
|
15.1 mmHg^2
Standard Error 4.0
|
2.6 mmHg^2
Standard Error 0.7
|
1.4 mmHg^2
Standard Error 0.5
|
|
BPV
High Frequency Systolic Blood Pressure Power(0.15 - 0.40 Hz)
|
0.7 mmHg^2
Standard Error 0.2
|
2.5 mmHg^2
Standard Error 0.5
|
0.9 mmHg^2
Standard Error 0.2
|
1.7 mmHg^2
Standard Error 0.7
|
1.2 mmHg^2
Standard Error 0.2
|
1.5 mmHg^2
Standard Error 0.4
|
|
BPV
Total Systolic Blood Pressure Power(0.04 - 0.40 Hz)
|
6.8 mmHg^2
Standard Error 1.8
|
10.2 mmHg^2
Standard Error 1.7
|
7.8 mmHg^2
Standard Error 1.4
|
16.8 mmHg^2
Standard Error 4
|
3.8 mmHg^2
Standard Error 0.8
|
2.8 mmHg^2
Standard Error 0.7
|
PRIMARY outcome
Timeframe: 7 minutes of paced or unpaced breathingPopulation: Repeated measures in 12 participants made in 1 study visit.
Peripheral oxygen saturation during paced or unpaced breathing
Outcome measures
| Measure |
0.083 Hz Breathing
n=12 Participants
Frequency: 0.083 Hz Duty Cycle: 6 second inhale; 6 second exhale
|
Box Breathing
n=12 Participants
Frequency: 0.083 Hz. Duty Cycle: 3 second inhale; 3 second hold: 3 second exhale: 3 second hold.
|
Extended Exhale Breathing
n=12 Participants
Frequency: 0.083 Hz Duty Cycle: 4 sec Inhale: 8 sec exhale
|
Ujjayi Breathing
n=12 Participants
Frequency: 0.083 Hz Duty Cycle: 6 sec Inhale: 6 sec exhale with throat resistance
|
Unpaced Breathing
n=12 Participants
Frequency: Variable Duty Cycle: Variable
|
0.25 Hz Breathing
n=12 Participants
Frequency: 0.25 Hz Duty Cycle: 2 second inhale: 2 second exhale
|
|---|---|---|---|---|---|---|
|
SpO2
|
97.2 % O2 satuation
Standard Error 0.3
|
96.6 % O2 satuation
Standard Error 0.5
|
96.7 % O2 satuation
Standard Error 0.4
|
97.6 % O2 satuation
Standard Error 0.3
|
96.1 % O2 satuation
Standard Error 0.6
|
96.9 % O2 satuation
Standard Error 0.5
|
PRIMARY outcome
Timeframe: 7 minutes of paced or unpaced breathingPopulation: Repeated measurements in 12 participants made during 1 study visit.
Expired CO2 from a nasal cannula
Outcome measures
| Measure |
0.083 Hz Breathing
n=12 Participants
Frequency: 0.083 Hz Duty Cycle: 6 second inhale; 6 second exhale
|
Box Breathing
n=12 Participants
Frequency: 0.083 Hz. Duty Cycle: 3 second inhale; 3 second hold: 3 second exhale: 3 second hold.
|
Extended Exhale Breathing
n=12 Participants
Frequency: 0.083 Hz Duty Cycle: 4 sec Inhale: 8 sec exhale
|
Ujjayi Breathing
n=12 Participants
Frequency: 0.083 Hz Duty Cycle: 6 sec Inhale: 6 sec exhale with throat resistance
|
Unpaced Breathing
n=12 Participants
Frequency: Variable Duty Cycle: Variable
|
0.25 Hz Breathing
n=12 Participants
Frequency: 0.25 Hz Duty Cycle: 2 second inhale: 2 second exhale
|
|---|---|---|---|---|---|---|
|
Expired Carbon Dioxide (CO2)
|
36 mmHg
Standard Error 1
|
37 mmHg
Standard Error 1
|
36 mmHg
Standard Error 1
|
32 mmHg
Standard Error 2
|
35 mmHg
Standard Error 1
|
31 mmHg
Standard Error 1
|
Adverse Events
Spinal Cord Injury
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place