Trial Outcomes & Findings for Breathing Interventions for Relaxation: Dosing Through Extended Exhale (NCT NCT02870868)

Last Updated: 2024-05-29

Results Overview

This is a proxy measure of parasympathetic tone. In normal healthy adults, the average value is around 600 ms\^2 (miliseconds\*miliseconds). In hypertensive adults, the average value is around 100 ms\^2. In patients with autonomic failure (who lacks parasympathetic tone), the average value is around 20 ms\^2.

Recruitment status

COMPLETED

Study phase

Target enrollment

99 participants

Primary outcome timeframe

Baseline

Results posted on

2024-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	Slow Breathing With Exhale Greater Than Inhale Slow breathing performed with time of exhale longer than inhale	Slow Breathing With Exhale Equal to Inhale Slow breathing performed with time of exhale equal to inhale
Overall Study STARTED	49	50
Overall Study COMPLETED	47	49
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Slow Breathing With Exhale Greater Than Inhale Slow breathing performed with time of exhale longer than inhale	Slow Breathing With Exhale Equal to Inhale Slow breathing performed with time of exhale equal to inhale
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Erroneous electrocardiographic measurements for spectral analyses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Slow Breathing With Exhale Greater Than Inhale n=49 Participants Slow breathing: Slow breathing techniques from yoga	Slow Breathing With Exhale Equal to Inhale n=50 Participants Slow breathing: Slow breathing techniques from yoga	Total n=99 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=49 Participants	0 Participants n=50 Participants	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=49 Participants	50 Participants n=50 Participants	99 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=49 Participants	0 Participants n=50 Participants	0 Participants n=99 Participants
Age, Continuous	41.2 years STANDARD_DEVIATION 9.2 • n=49 Participants	41.0 years STANDARD_DEVIATION 8.7 • n=50 Participants	41.2 years STANDARD_DEVIATION 8.9 • n=99 Participants
Sex: Female, Male Female	39 Participants n=49 Participants	39 Participants n=50 Participants	78 Participants n=99 Participants
Sex: Female, Male Male	10 Participants n=49 Participants	11 Participants n=50 Participants	21 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=49 Participants	6 Participants n=50 Participants	10 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=49 Participants	44 Participants n=50 Participants	89 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=49 Participants	0 Participants n=50 Participants	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=49 Participants	0 Participants n=50 Participants	0 Participants n=99 Participants
Race (NIH/OMB) Asian	6 Participants n=49 Participants	1 Participants n=50 Participants	7 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=49 Participants	0 Participants n=50 Participants	1 Participants n=99 Participants
Race (NIH/OMB) Black or African American	6 Participants n=49 Participants	4 Participants n=50 Participants	10 Participants n=99 Participants
Race (NIH/OMB) White	34 Participants n=49 Participants	45 Participants n=50 Participants	79 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=49 Participants	0 Participants n=50 Participants	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=49 Participants	0 Participants n=50 Participants	2 Participants n=99 Participants
Region of Enrollment United States	49 participants n=49 Participants	50 participants n=50 Participants	99 participants n=99 Participants
High Frequency Heart Rate Variability	399 milliseconds^second STANDARD_DEVIATION 355 • n=41 Participants • Erroneous electrocardiographic measurements for spectral analyses	421 milliseconds^second STANDARD_DEVIATION 350 • n=35 Participants • Erroneous electrocardiographic measurements for spectral analyses	409 milliseconds^second STANDARD_DEVIATION 350 • n=76 Participants • Erroneous electrocardiographic measurements for spectral analyses
PROMIS Anxiety Scale	56.2 units on a scale STANDARD_DEVIATION 4.8 • n=47 Participants • Missing data	56.5 units on a scale STANDARD_DEVIATION 5.4 • n=49 Participants • Missing data	56.444 units on a scale STANDARD_DEVIATION 4.8 • n=96 Participants • Missing data

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Slow Breathing With Exhale Greater Than Inhale n=41 Participants Slow breathing: Slow breathing techniques from yoga	Slow Breathing With Exhale Equal to Inhale n=35 Participants Slow breathing: Slow breathing techniques from yoga
Magnitude of Change in High Frequency Heart Rate Variability	399 milliseconds^2 Standard Deviation 355	421 milliseconds^2 Standard Deviation 350

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Slow Breathing With Exhale Greater Than Inhale n=40 Participants Slow breathing: Slow breathing techniques from yoga	Slow Breathing With Exhale Equal to Inhale n=35 Participants Slow breathing: Slow breathing techniques from yoga
Magnitude of Change in High Frequency Heart Rate Variability	376 milliseconds^2 Standard Deviation 355	485 milliseconds^2 Standard Deviation 463

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Slow Breathing With Exhale Greater Than Inhale n=37 Participants Slow breathing: Slow breathing techniques from yoga	Slow Breathing With Exhale Equal to Inhale n=35 Participants Slow breathing: Slow breathing techniques from yoga
Magnitude of Change in High Frequency Heart Rate Variability	381 milliseconds^2 Standard Deviation 393	487 milliseconds^2 Standard Deviation 476

PRIMARY outcome

Timeframe: Baseline

Measure of psychological stress taken at baseline before any study intervention. The scale ranges from 0 (no anxiety) to 100 (maximal anxiety). In the normal adult population, the average of the PROMIS Cooperative Group. (2011). Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety score is 50. A higher score correlates with increased anxiety and a lower score correlates with lower anxiety.

Outcome measures

Outcome measures
Measure	Slow Breathing With Exhale Greater Than Inhale n=47 Participants Slow breathing: Slow breathing techniques from yoga	Slow Breathing With Exhale Equal to Inhale n=49 Participants Slow breathing: Slow breathing techniques from yoga
Magnitude of Change in PROMIS Anxiety Scale	56.2 units on a scale Standard Deviation 4.8	56.5 units on a scale Standard Deviation 5.4

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Slow Breathing With Exhale Greater Than Inhale n=47 Participants Slow breathing: Slow breathing techniques from yoga	Slow Breathing With Exhale Equal to Inhale n=49 Participants Slow breathing: Slow breathing techniques from yoga
Magnitude of Change in PROMIS Anxiety Scale	52.4 units on a scale Standard Deviation 5.1	53.9 units on a scale Standard Deviation 4.4

PRIMARY outcome

Timeframe: 12-weeks

Outcome measures

Outcome measures
Measure	Slow Breathing With Exhale Greater Than Inhale n=45 Participants Slow breathing: Slow breathing techniques from yoga	Slow Breathing With Exhale Equal to Inhale n=48 Participants Slow breathing: Slow breathing techniques from yoga
Magnitude of Change in PROMIS Anxiety Scale	52.0 units on a scale Standard Deviation 4.3	51.2 units on a scale Standard Deviation 5.6

Adverse Events

Slow Breathing With Exhale Greater Than Inhale

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Slow Breathing With Exhale Equal to Inhale

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Slow Breathing With Exhale Greater Than Inhale n=49 participants at risk Slow breathing: Slow breathing techniques from yoga	Slow Breathing With Exhale Equal to Inhale n=50 participants at risk Slow breathing: Slow breathing techniques from yoga
Respiratory, thoracic and mediastinal disorders Lightheadedness	0.00% 0/49 • 3 months	0.00% 0/50 • 3 months

Additional Information

Alfredo Gamboa

Vanderbilt University Medical Center

Phone: (615) 322-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place