Clinical trial NCT05480618: Slow Yogic-Derived Breathing and Respiration and Cardiovascular Variability in Spinal Cord Injury Patients
Official title: Effect of Slow Breathing and Yogic-Derived Breathing on Respiration and Cardiovascular Variability in Spinal Cord Injury Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Slow Breathing
Keywords: resonance
yogic
pranayama
spinal cord injury
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart Rate Variability
timeFrame: 1,5 hour during Slow-breathing
measure: beat-by-beat arterial pressure
timeFrame: 1,5 hour during Slow-breathing
measure: beat-by-beat limb blood flow
timeFrame: 1,5 hour during Slow-breathing
measure: peripheral capillary oxygen saturation (SpO2)
timeFrame: 1,5 hour during Slow-breathing
measure: respiratory excursions
timeFrame: 1,5 hour during Slow-breathing
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
References: