Trial Outcomes & Findings for Assessing Alternative Approaches for Blood Pressure Control: A3BC Trial (NCT NCT02110381)
NCT ID: NCT02110381
Last Updated: 2017-03-28
Results Overview
Blood pressure was measured using an automated cuff with subject in a seated position for at least 5 minutes. Six measurements were recorded at 1-minute intervals. The mean was used in analysis.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
8 weeks and 16 weeks
Results posted on
2017-03-28
Participant Flow
Medical records were screened for initial eligibility criteria between 9/2014 - 4/2015. Patients were then contacted via letter and phone to gauge interest.
After consent, participants completed a run-in period in which they measured their blood pressure at home for 2 weeks. Participants with multiple readings greater than 160mmHg SBP or 100mmHg DBP were considered screen failures (n=13, plus 1 withdrawal).
Participant milestones
| Measure |
Device Guided Breathing
Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
|
Isometric Hand Grip
Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
|
|---|---|---|
|
Single Modality
STARTED
|
9
|
9
|
|
Single Modality
COMPLETED
|
7
|
8
|
|
Single Modality
NOT COMPLETED
|
2
|
1
|
|
Dual Modality
STARTED
|
7
|
8
|
|
Dual Modality
Began Active Treatment
|
7
|
7
|
|
Dual Modality
COMPLETED
|
5
|
7
|
|
Dual Modality
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessing Alternative Approaches for Blood Pressure Control: A3BC Trial
Baseline characteristics by cohort
| Measure |
Device Guided Breathing
n=9 Participants
Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
|
Isometric Hand Grip
n=9 Participants
Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.75 years
STANDARD_DEVIATION 14.85 • n=5 Participants
|
52.67 years
STANDARD_DEVIATION 15.48 • n=7 Participants
|
54.59 years
STANDARD_DEVIATION 14.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Systolic Blood pressure (mmHg)
|
127.33 mmHg
STANDARD_DEVIATION 10.15 • n=5 Participants
|
133.57 mmHg
STANDARD_DEVIATION 17.89 • n=7 Participants
|
129.06 mmHg
STANDARD_DEVIATION 9.00 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks and 16 weeksPopulation: 9 subjects in each group were analyzed. These subjects represent the individuals who passed started the intervention phase of the study.
Blood pressure was measured using an automated cuff with subject in a seated position for at least 5 minutes. Six measurements were recorded at 1-minute intervals. The mean was used in analysis.
Outcome measures
| Measure |
Device Guided Breathing
n=9 Participants
Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
|
Isometric Hand Grip
n=9 Participants
Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
|
|---|---|---|
|
Change in Blood Pressure
Baseline Systolic Blood Pressure
|
127.33 mmHg (millimeters of mercury)
Standard Deviation 10.15
|
133.57 mmHg (millimeters of mercury)
Standard Deviation 17.89
|
|
Change in Blood Pressure
Change from baseline at 8-weeks
|
5.71 mmHg (millimeters of mercury)
Standard Deviation 13.92
|
3.43 mmHg (millimeters of mercury)
Standard Deviation 8.00
|
|
Change in Blood Pressure
Change from baseline at 16-weeks
|
3.50 mmHg (millimeters of mercury)
Standard Deviation 10.344
|
6.17 mmHg (millimeters of mercury)
Standard Deviation 12.30
|
SECONDARY outcome
Timeframe: 8 weeksSubjects recorded sessions on a log; they were expected to complete 5 days/week for 8 weeks of single modality exercise for a minimum of 40 reported sessions. Results are reported as number of subjects reporting a minimum of 40 sessions.
Outcome measures
| Measure |
Device Guided Breathing
n=7 Participants
Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
|
Isometric Hand Grip
n=7 Participants
Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
|
|---|---|---|
|
Adherence to Single Modality Exercise (Device Guided Breathing or Isometric Hand Grip)
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 8 weeksSubjects recorded sessions on a log; they were expected to complete 5 days/week for 8 weeks of single modality exercise for a minimum of 40 reported sessions. Results are reported as number of subjects reporting a minimum of 40 sessions.
Outcome measures
| Measure |
Device Guided Breathing
n=5 Participants
Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
|
Isometric Hand Grip
n=7 Participants
Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
|
|---|---|---|
|
Adherence to Dual Modality Exercise (Device Guided Breathing + Isometric Hand Grip)
|
3 Participants
|
3 Participants
|
Adverse Events
Device Guided Breathing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Isometric Hand Grip
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Screen Failures
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Device Guided Breathing
n=9 participants at risk
Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
|
Isometric Hand Grip
n=9 participants at risk
Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
|
Screen Failures
n=14 participants at risk
These subjects reflect individuals who: 1) consented to be in the study, 2) participated in the initial run-in period to evaluate blood pressure, 3) ended up not meeting the blood pressure criteria required for randomization
|
|---|---|---|---|
|
Cardiac disorders
High blood pressure
|
0.00%
0/9 • We were in contact with subjects for 18 weeks total.
|
0.00%
0/9 • We were in contact with subjects for 18 weeks total.
|
7.1%
1/14 • Number of events 1 • We were in contact with subjects for 18 weeks total.
|
|
Investigations
Tight blood pressure cuff
|
0.00%
0/9 • We were in contact with subjects for 18 weeks total.
|
0.00%
0/9 • We were in contact with subjects for 18 weeks total.
|
7.1%
1/14 • Number of events 1 • We were in contact with subjects for 18 weeks total.
|
|
Musculoskeletal and connective tissue disorders
Sore hands
|
0.00%
0/9 • We were in contact with subjects for 18 weeks total.
|
11.1%
1/9 • Number of events 1 • We were in contact with subjects for 18 weeks total.
|
0.00%
0/14 • We were in contact with subjects for 18 weeks total.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place