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

NCT ID: NCT05480618

Last Updated: 2023-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-22

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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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

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Spinal Cord Injuries Slow Breathing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This study will be a small prospective cohort (N= 20) 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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Spinal Cord Injury Subjects

20 medically stable male and female subjects between 18 and 60 years old, BMI between 18.5-35 kg/m2, with a history of SCI and who use a wheelchair were included. 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.

Group Type EXPERIMENTAL

Slow Breathing

Intervention Type 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:

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Yogic-Derived Breathing

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. BP \>140/90 mmHg
2. Current use of cardioactive medications (except medication to support blood pressure)
3. Current tobacco use
4. Significant arrhythmia
5. Coronary artery disease
6. Diabetes
7. Renal Disease
8. Cancer
9. Epilepsy or other neurological diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spaulding Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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J. Andrew Taylor

Associate Professor of Physical Medicine and Rehabilitation, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38507692 (View on PubMed)

Other Identifiers

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2022P001696

Identifier Type: -

Identifier Source: org_study_id

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