Trial Outcomes & Findings for Breathe: Slow Paced Breathing to Lower Blood Pressure (NCT NCT00328016)
NCT ID: NCT00328016
Last Updated: 2017-07-02
Results Overview
Breathing rate was monitored continuously via inductive plethysmography.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
After 15 minutes of guided breathing or control task
Results posted on
2017-07-02
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
|
Overall Study
COMPLETED
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Twelve subjects were excluded from data analysis due to either non-compliance with the intervention or abnormal breathing pattern during baseline session.
Baseline characteristics by cohort
| Measure |
Device Guided Breathing
n=23 Participants
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.
|
Control Group
n=21 Participants
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.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=23 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=44 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=23 Participants
|
20 Participants
n=21 Participants
|
43 Participants
n=44 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=23 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=44 Participants
|
|
Age, Continuous
|
51.9 years
STANDARD_DEVIATION 11.6 • n=16 Participants • Twelve subjects were excluded from data analysis due to either non-compliance with the intervention or abnormal breathing pattern during baseline session.
|
54.5 years
STANDARD_DEVIATION 8.0 • n=16 Participants • Twelve subjects were excluded from data analysis due to either non-compliance with the intervention or abnormal breathing pattern during baseline session.
|
53.2 years
STANDARD_DEVIATION 9.8 • n=32 Participants • Twelve subjects were excluded from data analysis due to either non-compliance with the intervention or abnormal breathing pattern during baseline session.
|
|
Sex: Female, Male
Female
|
15 Participants
n=23 Participants
|
11 Participants
n=21 Participants
|
26 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=23 Participants
|
10 Participants
n=21 Participants
|
18 Participants
n=44 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=16 Participants • 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.
|
16 participants
n=16 Participants • 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.
|
32 participants
n=32 Participants • 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.
|
PRIMARY outcome
Timeframe: After 15 minutes of guided breathing or control taskBreathing rate was monitored continuously via inductive plethysmography.
Outcome measures
| Measure |
Device Guided Breathing
n=16 Participants
Practiced slow breathing using Guided Breathing Device
|
Control Group
n=16 Participants
Practiced passive attention to breathing
|
|---|---|---|
|
Breathing Rate
|
9.4 Breaths/minute
Standard Error 3.6
|
13.7 Breaths/minute
Standard Error 4.7
|
SECONDARY outcome
Timeframe: After 15 minutes of guided breathing or control taskMinute Ventilation was continuously monitored via inductive plethysmography
Outcome measures
| Measure |
Device Guided Breathing
n=16 Participants
Practiced slow breathing using Guided Breathing Device
|
Control Group
n=16 Participants
Practiced passive attention to breathing
|
|---|---|---|
|
Minute Ventilation
|
7.6 L/min
Standard Error 3.0
|
5.6 L/min
Standard Error 1.8
|
SECONDARY outcome
Timeframe: After 15 minutes of guided breathing or control taskEnd tidal CO2 was monitored continuously using a respiratory gas monitor
Outcome measures
| Measure |
Device Guided Breathing
n=16 Participants
Practiced slow breathing using Guided Breathing Device
|
Control Group
n=16 Participants
Practiced passive attention to breathing
|
|---|---|---|
|
End Tidal CO2 (PetCO2)
|
30.1 mmHg
Standard Error 5.6
|
36.5 mmHg
Standard Error 3.3
|
Adverse Events
Device Guided Breathing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jessica McNeeley, Research Fellow
National Institute on Aging
Phone: 410-558-8110
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place