High Blood Pressure
Conditions
Keywords
hypertension, high blood pressure, meditation
Brief summary
The purpose of this study is to investigate the nature of the physiological reasons for the decreases in resting blood pressure that can result from systematic practice of computer-guided breathing exercises or meditative relaxation.
Detailed description
In this randomized clinical trial, persons with moderately elevated blood pressure were trained in either computer-guided breathing exercises or meditative relaxation to breathing. The computer-guided breathing exercise involves listening to tones of ascending and descending pitch to which breathing is entrained to low frequencies over a 15 minute interval. The meditative relaxation involves passive attention to natural breathing for the same duration. Participants will perform these breathing exercises daily at home for four weeks. Before and after the intervention, respiratory, cardiovascular, and urinary endogenous digitalis-like factors will be systematically recorded to determine the extent to which chronic neuroendocrine changes underlie the reductions in blood pressure.
Interventions
BEHAVIORALGuided Breathing
The participant will engage in daily 15 min sessions of meditative relaxation that involves quiet attention to breathing pattern with no attempt to manipulate breathing pattern
DEVICERESPeRATE
The participant will be trained to perform a guided breathing task that involves a chest expansion sensor, battery-powered microcomputer, and earphones
Sponsors
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Over 21 years * Systolic blood pressure 130-160 or diastolic blood pressure 85-100
Exclusion criteria
* More than one antihypertensive medication * Beta blockers, angiotensin converting enzyme inhibitors or angiotensin receptor blockers * History of coronary artery disease, heart failure, stroke, angina or coronary revascularization * Kidney disease, defined as plasma creatinine \> 1.5mg/dL * Diabetes, defined by insulin or oral hypoglycemic medication or blood sugar \> 126mg/dL * Pulmonary disease, defined as chronic obstructive pulmonary disease, bronchitis, asthma, or use of inhaler * Upper respiratory infection during past 30 days * Medication that affects central nervous system function * Steroid use * Current pregnancy or lactation within past six months * Current birth control medication or hormone replacement therapy * Condition that in the judgment of the Principal Investigator is incompatible with the research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breathing Rate | After 15 minutes of guided breathing or control task | Breathing rate was monitored continuously via inductive plethysmography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minute Ventilation | After 15 minutes of guided breathing or control task | Minute Ventilation was continuously monitored via inductive plethysmography |
| End Tidal CO2 (PetCO2) | After 15 minutes of guided breathing or control task | End tidal CO2 was monitored continuously using a respiratory gas monitor |
Countries
United States
Participant flow
Recruitment details
102 Subjects responded to advertising and were assessed for eligibility. Forty-four were enrolled and randomized. 23 were randomized to guided breathing and 21 were on the Control arm.
Participants by arm
| Arm | Count |
|---|---|
| Device Guided Breathing The Device Guided Breathing (DGB) group were instructed to sit comfortably with eyes closed and arms and legs uncrossed. Individual breathing rate was initially determined from an expandable band around the torso connected to a commercially available device (RESPeRATE, Lod, Israel) that presented distinctive tones via earphone. Each subject was instructed to inspire during ascending tones and expire during descending tones, following two training sessions, respiration, blood pressure and breathing parameters were monitored during a 10 min rest period, a 15 min guided breathing task period, and a 10 min recovery period. | 23 |
| Control Group The Control Group were instructed to sit in the same matter, passively attend to their breathing, and silently repeat 'one' during each exhalation. If thoughts came to mind, they were instructed to calmly refocus attention on breathing. Following two sessions of practice of passive attention to breathing, blood pressure and breathing parameters of each subject were also monitored during a 10 min baseline, 15 min passive attention to breathing and 10 min recovery period. | 21 |
| Total | 44 |
Baseline characteristics
| Characteristic | Control Group | Device Guided Breathing | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 23 Participants | 43 Participants |
| Age, Continuous | 54.5 years STANDARD_DEVIATION 8 | 51.9 years STANDARD_DEVIATION 11.6 | 53.2 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment United States | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 11 Participants | 15 Participants | 26 Participants |
| Sex: Female, Male Male | 10 Participants | 8 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 21 |
| serious Total, serious adverse events | 0 / 23 | 0 / 21 |
Outcome results
Primary
Breathing Rate
Breathing rate was monitored continuously via inductive plethysmography.
Time frame: After 15 minutes of guided breathing or control task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Guided Breathing | Breathing Rate | 9.4 Breaths/minute | Standard Error 3.6 |
| Control Group | Breathing Rate | 13.7 Breaths/minute | Standard Error 4.7 |
Secondary
End Tidal CO2 (PetCO2)
End tidal CO2 was monitored continuously using a respiratory gas monitor
Time frame: After 15 minutes of guided breathing or control task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Guided Breathing | End Tidal CO2 (PetCO2) | 30.1 mmHg | Standard Error 5.6 |
| Control Group | End Tidal CO2 (PetCO2) | 36.5 mmHg | Standard Error 3.3 |
Secondary
Minute Ventilation
Minute Ventilation was continuously monitored via inductive plethysmography
Time frame: After 15 minutes of guided breathing or control task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Guided Breathing | Minute Ventilation | 7.6 L/min | Standard Error 3 |
| Control Group | Minute Ventilation | 5.6 L/min | Standard Error 1.8 |