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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| University of Wisconsin, Milwaukee | OTHER |
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The benefits of regular physical activity are well-established. Furthermore, the investigators have previously shown that in a population of patients with implanted pacemakers, those who exercise more than 2 hours daily have improved survival compared with those who exercise less than 2 hours daily. In this study, the aim f the investigators is to determine whether the offering subjects with pacemakers who have low levels of physical activity at baseline counseling to increase physical activity levels is effective as measured by their implanted device as well as by an external pacemaker.
The investigators seek to enroll about 30 patients into a 6-month 1:1 randomized interventional trial comparing the levels of physical activity in 2 groups, those who receive physical activity counseling versus usual care. The activity levels will be measured with external pedometers and with accelerometers embedded within the pacemaker device.
The benefits of habitual physical activity (PA, activities of at least moderate intensity defined as ≥ 3 metabolic equivalents (METs)) are well-recognized. Emerging information from large data sets strongly suggest high levels of sedentary behavior, defined as activities <1.5 METs (equivalent to the amount of energy expended during seated activities such as computer work) increases the risk of diabetes, cardiovascular disease, and death, independent of the amount and intensity PA. The increased risk of sedentary behavior appears to be mediated at least in part by reduced insulin sensitivity, impaired lipid metabolism, increased vascular inflammation, and increased thrombotic tendencies.
The internal accelerometer embedded in Medtronic pacemakers registers, stores, and reports total number of "active time" based on a threshold activity intensity level of approximately 70 steps/min (estimated to be > 1.5 METs). This implanted accelerometer, combined with the regular follow-up required for appropriate care make individuals who have undergone Medtronic pacemaker implantation an ideal population in which to evaluate the impact of altering sedentary behavior on mortality and cardiovascular events.
The hypotheses are as follows:
Potential subjects who are interested in the study will have a screening visit to determine whether they meet the inclusion and exclusion criteria. Those who qualify and agree to participate will be randomized into either the Physical Activity Counseling arm (intervention arm) or the Patient Usual Care arm (control arm).
Subjects in the interventional arm will be given a pedometer and physical activity counseling on a regular basis for 3 months. Physical activity data from their external pedometer will be collected every 2 weeks via phone calls. Accelerometry data from the implanted pacemaker will be collected from the subject's medical record as pacemaker interrogations are performed every 3 months as part of routine clinical care. After the initial 3 month interventional phase is complete, these subjects will be followed for another 3 months with collection of pedometer as well as accelerometer data as described above.
Subjects in the control arm will be given pedometers for the week prior to pacemaker interrogation. These subjects will be called to report the number of steps they walked each day prior to the interrogation. Their accelerometry data will be captured through routine clinical pacemaker interrogations.
The primary outcome is the physical activity level in each group as measured by the accelerometer at time 0, 3 months and 6 months. The secondary outcome is the step count in each group as measured by the pedometer at the same time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Activity Counseling | Experimental | Subjects will be given counseling on the benefits of increasing activity, instructions on how to slowly increase their activity over 12 weeks with walking, record their daily step counts, and have bi-weekly phone calls with study staff to reinforce the training and help them overcome barriers to being physically active. |
|
| Patient Usual Care | Placebo Comparator | Subjects will undergo usual care without intervention in this study arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity counseling | Behavioral | Subjects in this arm will receive counseling on how to increase their physical activity level. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity Level as Measured by Embedded Accelerometer | This is the daily measured active hours in the device | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity Level as Measured by External Pedometer | this is a daily step count (one week average) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Widlansky, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin and Froedtert Memorial Lutheran Hospital | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32375676 | Derived | Puppala VK, Hofeld BC, Anger A, Tyagi S, Strath SJ, Fox J, Berger MG, Ahn KW, Widlansky ME. Pacemaker detected active minutes are superior to pedometer-based step counts in measuring the response to physical activity counseling in sedentary older adults. BMC Geriatr. 2020 May 6;20(1):162. doi: 10.1186/s12877-020-01559-y. |
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Step-count data from the pedometers that the subjects wear along with the activity level as measured by the subject's pacemaker will be shared with the collaborating researchers at Medtronic and at UW-Milwaukee. This data will be obtained via phone conversations with the subject and via in-clinic or remote interrogations of the implanted pacemakers. The data will become available on an ongoing basis during the study duration as participants are contacted per the study protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Physical Activity Counseling | Subjects will be given counseling on the benefits of increasing activity, instructions on how to slowly increase their activity over 12 weeks with walking, record their daily step counts, and have bi-weekly phone calls with study staff to reinforce the training and help them overcome barriers to being physically active. Physical activity counseling: Subjects in this arm will receive counseling on how to increase their physical activity level. |
| FG001 | Patient Usual Care | Subjects will undergo usual care without intervention in this study arm Usual care: Subjects will undergo their usual care without intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Physical Activity Counseling | Subjects will be given counseling on the benefits of increasing activity, instructions on how to slowly increase their activity over 12 weeks with walking, record their daily step counts, and have bi-weekly phone calls with study staff to reinforce the training and help them overcome barriers to being physically active. Physical activity counseling: Subjects in this arm will receive counseling on how to increase their physical activity level. |
| 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 | Physical Activity Level as Measured by Embedded Accelerometer | This is the daily measured active hours in the device | Posted | Mean | Standard Deviation | active hours/day | 6 months |
|
Information on adverse events were recorded over the 1st 12 weeks of the study which contained the intervention
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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 | Physical Activity Counseling | Subjects will be given counseling on the benefits of increasing activity, instructions on how to slowly increase their activity over 12 weeks with walking, record their daily step counts, and have bi-weekly phone calls with study staff to reinforce the training and help them overcome barriers to being physically active. Physical activity counseling: Subjects in this arm will receive counseling on how to increase their physical activity level. |
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Unable to complete projected enrollment due to difficulties with recruitment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amberly Anger | Medical College of Wisconsin | 414-955-6708 | aanger@mcw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2016 | May 15, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Usual care | Behavioral | Subjects will undergo their usual care without intervention |
|
| BG001 | Patient Usual Care | Subjects will undergo usual care without intervention in this study arm Usual care: Subjects will undergo their usual care without intervention |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| History of Sustained Ventricular Tachycardia | Count of Participants | Participants |
|
| History of Non-Sustained Ventricular Tachycardia | Count of Participants | Participants |
|
| Sick Sinus Syndrome | Count of Participants | Participants |
|
| High Degree AV Block | Count of Participants | Participants |
|
| Creatinine Clearance < 60 mL/min/1.73 m2 | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Hyperlipidemia | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Heart Failure | Count of Participants | Participants |
|
| Coronary Stent | Count of Participants | Participants |
|
| Prior CABG | Count of Participants | Participants |
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| Prior CVA | Count of Participants | Participants |
|
| Atrial Fibrillation | Count of Participants | Participants |
|
| LVEF% | Mean | Standard Deviation | % |
|
| LV End Diastolic Dimension | Mean | Standard Deviation | mm |
|
| LV End Systolic Dimension | Mean | Standard Deviation | mm |
|
| Percent Atrial Pacing | Mean | Standard Deviation | % |
|
| Percent Ventricular Pacing | Mean | Standard Deviation | % |
|
| Moderate or Greater Mitral Regurgitation | Count of Participants | Participants |
|
| Current Smoker | Count of Participants | Participants |
|
| ACEI or ARB Therapy | Count of Participants | Participants |
|
| Beta Blocker Therapy | Count of Participants | Participants |
|
| HMG CoA Reductase Therapy | Count of Participants | Participants |
|
| SBP | Mean | Standard Deviation | mmHg |
|
| DBP | Mean | Standard Deviation | mmHg |
|
| HR | Mean | Standard Deviation | bpm |
|
| Calculated Gait Speed | Mean | Standard Deviation | m/sec |
|
| Pacemaker detected active minutes | Mean | Standard Deviation | hours/day |
|
| Pedometer-Based Daily Step Count | Mean | Standard Deviation | steps/day |
|
Subjects will undergo usual care without intervention in this study arm
Usual care: Subjects will undergo their usual care without intervention
|
|
| Secondary | Physical Activity Level as Measured by External Pedometer | this is a daily step count (one week average) | Posted | Mean | Standard Deviation | steps/day | 6 months |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Patient Usual Care | Subjects will undergo usual care without intervention in this study arm Usual care: Subjects will undergo their usual care without intervention | 0 | 6 | 0 | 6 | 0 | 6 |
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