Spinal Cord InjuriesSCOGANCT05480618

Slow Yogic-Derived Breathing and Respiration and Cardiovascular Variability in Spinal Cord Injury Patients

A study testing Slow Breathing in people with Spinal Cord Injuries and Slow Breathing, run by Spaulding Rehabilitation Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Spinal Cord Injuries, Slow Breathing
What is being tested?: Slow Breathing
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 22 Aug 2022to 20 Jan 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age: 18-60 years old
Wheelchair user
Medically stable \& able to follow directions
Body mass index (18.5 - 35 kg/m2)

Who cannot join

BP >140/90 mmHg
Current use of cardioactive medications (except medication to support blood pressure)
Current tobacco use
Significant arrhythmia
Coronary artery disease
Diabetes

Show all 9Show fewer

Renal Disease
Cancer
Epilepsy or other neurological diseases

Trial locations and contacts

1 site in 1 country.

United States1 site

Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, 02138

Other trials in United States

About this study

Official title: Effect of Slow Breathing and Yogic-Derived Breathing on Respiration and Cardiovascular Variability in Spinal Cord Injury Patients

Read the detailed description

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.

Conditions: Spinal Cord Injuries, Slow Breathing
Being tested: Slow Breathing
Keywords: resonance, yogic, pranayama, spinal cord injury
Medical subject headings: Spinal Cord Injuries, Hypoventilation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Slow BreathingBehavioural
Also called Yogic-Derived 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.

Study groups in NCT05480618
Study group	Role	What they receive
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. Receives: Behavioral: Slow Breathing

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 7 minutes of paced or unpaced breathing at single study visit on Day 14
SpO2
Peripheral oxygen saturation during paced or unpaced breathing
Measured: 7 minutes of paced or unpaced breathing at single study visit on Day 14
Expired Carbon Dioxide (CO2)
Expired CO2 from a nasal cannula
Measured: 7 minutes of paced or unpaced breathing at single study visit on Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Aug 202220 Jan 2024

First posted29 Jul 2022
Study start22 Aug 2022
Primary completion20 Jan 2024
Study completion20 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05480618
Sponsor's protocol ID: 2022P001696
Acronym: SCOGA
Status last verified: May 2026
First submitted: 27 Jul 2022
Last updated: 29 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 38507692

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Slow Breathing and Yogic-Derived Breathing on Respiration and Cardiovascular Variability in Spinal Cord Injury Patients
ClinicalTrials.gov ID: NCT05480618
Acronym / sponsor ID: SCOGA / 2022P001696
Conditions: Spinal Cord Injuries, Slow Breathing
Keywords: resonance, yogic, pranayama, spinal cord injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Spaulding Rehabilitation HospitalUniversity, hospital or other
Study start: 22 Aug 2022 (actual)
Primary completion: 20 Jan 2024 (actual)
Study completion: 20 Jan 2024 (actual)
First posted: 29 Jul 2022 (actual)
Results: Posted 28 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 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.

Arm	Type	Receives
Spinal Cord Injured Participants	Experimental	Behavioral: Slow Breathing17 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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Age: 18-60 years old
Wheelchair user
Medically stable \& able to follow directions
Body mass index (18.5 - 35 kg/m2)

Key exclusion criteria (9 listed)

BP >140/90 mmHg
Current use of cardioactive medications (except medication to support blood pressure)
Current tobacco use
Significant arrhythmia
Coronary artery disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Slow BreathingAlso: Yogic-Derived BreathingOn 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.	Behavioural	Spinal Cord Injured Participants

Primary outcome

HRV
Time frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14
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.
BPV
Time frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14
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.
SpO2
Time frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14
Peripheral oxygen saturation during paced or unpaced breathing
Expired Carbon Dioxide (CO2)
Time frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14
Expired CO2 from a nasal cannula

Results and safety

Results posted to the registry on 28 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spinal Cord Injury	17	12

Primary outcome: HRV

Time frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14. Mean (Standard Error). Unit: ms^2

Measure	Unpaced Breathing n = 12	0.25 Hz Breathing n = 12	0.083 Hz Breathing n = 12	Box Breathing n = 12	Extended Exhale Breathing n = 12	Ujjayi Breathing n = 12
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)

Population analysed: Repeated measures in 12 individuals during 1 study visit

Primary outcome: BPV

Time frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14. Mean (Standard Error). Unit: mmHg^2

Measure	Unpaced Breathing n = 12	0.25 Hz Breathing n = 12	0.083 Hz Breathing n = 12	Box Breathing n = 12	Extended Exhale Breathing n = 12	Ujjayi Breathing n = 12
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)

Population analysed: Repeated measures in the same 12 participants in 1 study visit.

Primary outcome: SpO2

Time frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14. Mean (Standard Error). Unit: % O2 satuation

Measure	Unpaced Breathing n = 12	0.25 Hz Breathing n = 12	0.083 Hz Breathing n = 12	Box Breathing n = 12	Extended Exhale Breathing n = 12	Ujjayi Breathing n = 12
Value	96.1 (0.6)	96.9 (0.5)	97.2 (0.3)	96.6 (0.5)	96.7 (0.4)	97.6 (0.3)

Population analysed: Repeated measures in 12 participants made in 1 study visit.

Primary outcome: Expired Carbon Dioxide (CO2)

Time frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14. Mean (Standard Error). Unit: mmHg

Measure	Unpaced Breathing n = 12	0.25 Hz Breathing n = 12	0.083 Hz Breathing n = 12	Box Breathing n = 12	Extended Exhale Breathing n = 12	Ujjayi Breathing n = 12
Value	35 (1)	31 (1)	36 (1)	37 (1)	36 (1)	32 (2)

Population analysed: Repeated measurements in 12 participants made during 1 study visit.

Adverse events

Time frame: From enrollment until end of study visit, up to 2 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spinal Cord Injury	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38507692Mazur 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Slow Breathing in people with Spinal Cord Injuries and Slow Breathing, run by Spaulding Rehabilitation Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HRV (time frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05480618, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.