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Assessing Alternative Approaches for Blood Pressure Control: A3BC Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02110381
Recruitment Status : Terminated (It was a pilot study and we enrolled sufficient numbers to evaluate the proposed outcomes.)
First Posted : April 10, 2014
Results First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Elizabeth A. Jackson, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Interventions Device: Device guided breathing RESPeRATE
Device: Isometric hand grip Zona Plus
Enrollment 32
Recruitment Details Medical records were screened for initial eligibility criteria between 9/2014 - 4/2015. Patients were then contacted via letter and phone to gauge interest.
Pre-assignment Details 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).
Arm/Group Title Device Guided Breathing Isometric Hand Grip
Hide Arm/Group Description

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.

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.

Period Title: Single Modality
Started 9 9
Completed 7 8
Not Completed 2 1
Period Title: Dual Modality
Started 7 8
Began Active Treatment 7 7
Completed 5 7
Not Completed 2 1
Arm/Group Title Device Guided Breathing Isometric Hand Grip Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 9 9 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 18 participants
56.75  (14.85) 52.67  (15.48) 54.59  (14.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
Female
2
  22.2%
5
  55.6%
7
  38.9%
Male
7
  77.8%
4
  44.4%
11
  61.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
American Indian or Alaska Native
1
  11.1%
0
   0.0%
1
   5.6%
Asian
0
   0.0%
1
  11.1%
1
   5.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  11.1%
1
   5.6%
White
7
  77.8%
7
  77.8%
14
  77.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  11.1%
0
   0.0%
1
   5.6%
Systolic Blood pressure (mmHg)  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 9 participants 9 participants 18 participants
127.33  (10.15) 133.57  (17.89) 129.06  (9.00)
1.Primary Outcome
Title Change in Blood Pressure
Hide Description 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.
Time Frame 8 weeks and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
9 subjects in each group were analyzed. These subjects represent the individuals who passed started the intervention phase of the study.
Arm/Group Title Device Guided Breathing Isometric Hand Grip
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: mmHg (millimeters of mercury)
Baseline Systolic Blood Pressure Number Analyzed 9 participants 9 participants
127.33  (10.15) 133.57  (17.89)
Change from baseline at 8-weeks Number Analyzed 9 participants 9 participants
5.71  (13.92) 3.43  (8.00)
Change from baseline at 16-weeks Number Analyzed 4 participants 6 participants
3.50  (10.344) 6.17  (12.30)
2.Secondary Outcome
Title Adherence to Single Modality Exercise (Device Guided Breathing or Isometric Hand Grip)
Hide Description Subjects 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.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Device Guided Breathing Isometric Hand Grip
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 7 7
Measure Type: Count of Participants
Unit of Measure: Participants
7
 100.0%
4
  57.1%
3.Secondary Outcome
Title Adherence to Dual Modality Exercise (Device Guided Breathing + Isometric Hand Grip)
Hide Description Subjects 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.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Device Guided Breathing Isometric Hand Grip
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 5 7
Measure Type: Count of Participants
Unit of Measure: Participants
3
  60.0%
3
  42.9%
Time Frame We were in contact with subjects for 18 weeks total.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Device Guided Breathing Isometric Hand Grip Screen Failures
Hide Arm/Group Description

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.

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.

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
All-Cause Mortality
Device Guided Breathing Isometric Hand Grip Screen Failures
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Device Guided Breathing Isometric Hand Grip Screen Failures
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/9 (0.00%)      0/14 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Device Guided Breathing Isometric Hand Grip Screen Failures
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      1/9 (11.11%)      1/14 (7.14%)    
Cardiac disorders       
High blood pressure * [1]  0/9 (0.00%)  0 0/9 (0.00%)  0 1/14 (7.14%)  1
Investigations       
Tight blood pressure cuff * [2]  0/9 (0.00%)  0 0/9 (0.00%)  0 1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders       
Sore hands * [3]  0/9 (0.00%)  0 1/9 (11.11%)  1 0/14 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Blood pressure readings of greater than 200mmHg systolic blood pressure and/or greater than 100mmHg diastolic pressure
[2]
Blood pressure cuff was too tight for subject comfort
[3]
Musculoskeletal soreness from using the isometric handgrip device
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Elizabeth Jackson
Organization: University of Michigan
Phone: 734-998-7411
EMail: lisjacks@med.umich.edu
Layout table for additonal information
Responsible Party: Elizabeth A. Jackson, University of Michigan
ClinicalTrials.gov Identifier: NCT02110381    
Other Study ID Numbers: HUM00086973
First Submitted: April 7, 2014
First Posted: April 10, 2014
Results First Submitted: February 7, 2017
Results First Posted: March 28, 2017
Last Update Posted: March 28, 2017