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Assessing Alternative Approaches for Blood Pressure Control: A3BC Trial

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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   --/--      --/--      --/--    
Show Serious Adverse Events 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%)    
Show Other (Not Including Serious) Adverse Events 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
Name/Title: Dr. Elizabeth Jackson
Organization: University of Michigan
Phone: 734-998-7411
Responsible Party: Elizabeth A. Jackson, University of Michigan
ClinicalTrials.gov Identifier: NCT02110381     History of Changes
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