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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Guided Breathing | Experimental | Individual breathing rate was determined from an expandable band around the torso connected to a commercially available device (RESPeRATE, Lod, Israel) that presented distinctive tones via earphones. |
|
| Control Group | Placebo Comparator | Control group were instructed to sit in the same manner passively attend to their breathing, and silently repeat 'one' during each exhalation. If other thoughts came to mind, they were instructed to calmly attend to their breathing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided Breathing | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Breathing Rate | Breathing rate was monitored continuously via inductive plethysmography. | After 15 minutes of guided breathing or control task |
| Measure | Description | Time Frame |
|---|---|---|
| Minute Ventilation | Minute Ventilation was continuously monitored via inductive plethysmography | After 15 minutes of guided breathing or control task |
| End Tidal CO2 (PetCO2) | End tidal CO2 was monitored continuously using a respiratory gas monitor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William B. Ershler, M.D. | NIA, Clinical research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIA Clinical Research Unit | Baltimore | Maryland | 21225 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15062893 | Background | Meles E, Giannattasio C, Failla M, Gentile G, Capra A, Mancia G. Nonpharmacologic treatment of hypertension by respiratory exercise in the home setting. Am J Hypertens. 2004 Apr;17(4):370-4. doi: 10.1016/j.amjhyper.2003.12.009. | |
| 15470284 | Background | Elliot WJ, Izzo JL Jr, White WB, Rosing DR, Snyder CS, Alter A, Gavish B, Black HR. Graded blood pressure reduction in hypertensive outpatients associated with use of a device to assist with slow breathing. J Clin Hypertens (Greenwich). 2004 Oct;6(10):553-9; quiz 560-1. doi: 10.1111/j.1524-6175.2004.03553.x. |
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There is no plan to share individual level data.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Of the 44 subjects randomly assigned to treatment and control group, 12 subjects were excluded from data analysis due to either non-compliance with the intervention or abnormal breathing pattern during baseline session.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Breathing Rate | Breathing rate was monitored continuously via inductive plethysmography. | Posted | Mean | Standard Error | Breaths/minute | After 15 minutes of guided breathing or control task |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 during an experimental session on a subsequent day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica McNeeley, Research Fellow | National Institute on Aging | 410-558-8110 | mcneeleyj@mail.nih.gov |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| RESPeRATE | Device | The participant will be trained to perform a guided breathing task that involves a chest expansion sensor, battery-powered microcomputer, and earphones |
|
| After 15 minutes of guided breathing or control task |
| 11319675 | Background | Grossman E, Grossman A, Schein MH, Zimlichman R, Gavish B. Breathing-control lowers blood pressure. J Hum Hypertens. 2001 Apr;15(4):263-9. doi: 10.1038/sj.jhh.1001147. |
| Background | Benson H. The Relaxation Response. New York: Avon Books, 1975 |
| 18820654 | Result | Anderson DE, McNeely JD, Chesney MA, Windham BG. Breathing variability at rest is positively associated with 24-h blood pressure level. Am J Hypertens. 2008 Dec;21(12):1324-9. doi: 10.1038/ajh.2008.292. Epub 2008 Sep 25. |
| 20200548 | Derived | Anderson DE, McNeely JD, Windham BG. Regular slow-breathing exercise effects on blood pressure and breathing patterns at rest. J Hum Hypertens. 2010 Dec;24(12):807-13. doi: 10.1038/jhh.2010.18. Epub 2010 Mar 4. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Twelve subjects were excluded from data analysis due to either non-compliance with the intervention or abnormal breathing pattern during baseline session. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Of the 44 subjects randomly assigned to treatment and control group, 12 subjects were excluded from data analysis due to either non-compliance with the intervention or abnormal breathing pattern during baseline session. | Number | participants |
|
| Participants |
|
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| Secondary | Minute Ventilation | Minute Ventilation was continuously monitored via inductive plethysmography | Posted | Mean | Standard Error | L/min | After 15 minutes of guided breathing or control task |
|
|
|
| Secondary | End Tidal CO2 (PetCO2) | End tidal CO2 was monitored continuously using a respiratory gas monitor | Posted | Mean | Standard Error | mmHg | After 15 minutes of guided breathing or control task |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | 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. | 0 | 21 | 0 | 21 |
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