Reducing Sedentary Time in Individuals With Pacemakers - Tracking By Pacemaker-Based Accelerometry
Phase: NA
Conditions: Physical Activity, Pacemaker, Cardiovascular Diseases, Arrythmia
Sponsor: Medical College of Wisconsin

Physical Activity and Pacemaker Study 
NCT03052829 
Initial Protocol approved:  12/21/2016

Phy 
 
Overview of approach:  Based upon our previous work, the overall 
experimental design of this study is a small pragmatic randomized controlled 
trial (RCT).  A general study diagram of events and procedures is present in 
Figure 2.   Potential subjects who fit inclusion/exclusion criteria will be 
approached for enrollment once they are identified as candidates for 
permanent pacemaker implantation or as patients with already implanted 
Medtronic Revo or EnRhythm pacemakers.  Individuals with, on average, less 
than 2 hours/day of active minutes over the prior 3 months (based in the 
pacemaker’s internal accelerometer daily active minute reading) will be 
eligible for randomization.  For individuals enrolled at the time of pacemaker 
implantation, the average active minutes for the time period of 3-6 months 
following implantation will be used to assess eligibility for randomization.  At 
the time of enrollment all subjects will have a detailed medical history 
obtained.  Thirty participants will be randomized across 2 parallel groups: an 
intervention group (n=15), or a Patient Usual Care (PUC) group (n=15).  The 
PAC intervention follows the 5 A’s (Assess, Advise, Agree, Assist, Arrange) 
model, which has been shown to be an effective clinical counseling tool for 
other health behaviors.14  Implanted Medtronic Pacemaker accelerometer 
data will be used to Assess physical activity levels. Subjects in the low active 
group will be referred to an intervention expert on the study staff.  Eligible 
patients will then be Advised of their activity levels, and migrate through the 5 
A’s intervention model for 12 weeks. A fuller description of the intervention is 
included below.  At the end of the 12 week active intervention, subjects in the 
intervention arm will enter a maintenance phase for an additional 3 months.  
During the study, pacemakers will be interrogated remotely or at clinic visits 
every 3 months.  All subjects in the intervention arm will be contacted every 2 
weeks to assess how they are doing with respect to the intervention.  The study 
schema is shown in Figure 1, described in accordance with the CONSORT 
statement’s recommendations for randomized clinical trials.  An outline of 
study procedures is presented in Table 1. 
 
Study setting. 

 
Subjects will be recruited from individuals who require permanent 
pacemaker placement at Froedtert Hospital and Zablocki VA Medical Center, 
both located in Milwaukee, WI.  
 
Participant eligibility and recruitment. 
 
Criteria for Enrollment and Randomization. 
Inclusion Criteria: 
1)  Age ≥ 55 years old 
2) Clinical indication for placement of permanent pacemaker or currently 
implanted pacemaker 
3) LVEF of ≥ 50% by most recent echocardiogram. 
4) Able to ambulate  
5) Average active time of ≤ 2 hours/day based on Revo or EnRhythm 
Accelerometer read out for the 3 month period prior to enrollment 
6) Able to take 650 steps over 10 minutes following pacemaker implantation 
(~2-2.5 mph walking speed) 
 
 
Exclusion Criteria: 
1) Follow up for implantation planned at a non-study center at the time of 
implantation. 
2) Individuals with and expected life span of 1 year or less at the time of 
implantation 
3) Known history of cognitive impairment or inability to follow study 
procedures 
4) Lack of stable internet access 
 

Randomization.  Randomization will occur at the patient level.  Upon 
potential eligibility being identified, subjects will be randomized in 3 blocks of 
10 participants and randomized 1:1 to each study arm.   We will enroll until we 
reach 15 subjects in each study arm who complete all study procedures. 
Randomization will be delivered via a random number generation sequence.  
Due to the nature of the trial, research staff, clinicians, and patients will not be 
blinded to patient assignment.   
 
Physical Activity Counseling Intervention Group:  The 12 week 
intervention is a multifaceted intervention that follows the 5 A’s (Assess, 
Advise, Agree, Assist, Arrange) model, designed to be both simple to 
implement and follow for patients.  It mimics a referral for education model 
that is used for patients who require a nutritionist or other specialist for 
behavioral modification.  The intervention includes the following elements.    
 
1) 
Assess: Subjects will undergo a physical activity assessment, utilizing 
the implanted Medtronic Pacemaker accelerometer data. 
2) 
Advise: Eligible patients will be shown the graph from our recent 
publication demonstrating the relationship between decreased active minute 
time and mortality to help build the case that an intervention is necessary. 
3) 
Agree: Those patients who agree enter into a shared decision making 
process to behavior change – in this case modifying physical activity behavior 
in an effort to decrease sedentary time. 
4) 
Assist: The patient will receive a written prescription that includes their 
baseline Medtronic Pacemaker accelerometer data, and a target to increase 
their activity.  Activity will be increased using the following: 
a. 
Self-regulatory monitoring: A pedometer with a target to increase steps 
by 10% per week, to a target of 10,000 steps/day. A calendar will be given for 
patients to write down daily amounts. 
b. 
Brief printed support materials – on different behavioral strategies to 
increase active behaviors 
c. 
A list of freely available internet-resources 

d. 
Bi-weekly telephone support: A member of the study staff will call each 
participant randomized to the PAC intervention group every other week. Calls 
will be limited to 5 minutes and used to offer support, advice, and solicit 
feedback. 
5) 
Arrange: A follow-up visit will be arranged for week 12, to retrieve 
outcome data for physical activity from the implanted Medtronic Pacemaker 
accelerometer. Alternatively, data will be obtained through convenient 
methods. 
 
Overall, our approach employs key strategies proven to increase the adoption 
and retention of lifestyle integrated habitual physical activity in older 
adults.15,16  These strategies included the use of frequent feedback,15 self-
regulation of activity,17,18 education and practice in realistic behavioral 
change strategies and goal setting,16 and rewarding.19    
Patient Usual Care (PAC) Group: The PAC group will undergo Implanted 
Medtronic Pacemaker Accelerometer data retrieval, but this data will not be 
shown to the patient, nor used to alter behavior.  This group will follow their 
typical clinical routine, and therefore represent a usual care approach. 
Communication of Physical Activity information:  All individuals with 
pacemakers will undergo interrogation of their device every 3 months during 
entire study period, including intervention phase and follow-up phase.  
Outcomes:   The primary outcome for this study is the number of active 
minutes as measured by the Medtronics Implanted Pacemaker accelerometer.   
 
Statistical Methods:  Baseline demographic and clinical data will be compared 
between groups by unpaired t-tests, Chi-squared tests, or non-parametric 
equivalents as appropriate.  The primary outcome will be compared between  
 
 
Data Analyses 
SPSS 24 and SigmaStat 12.5 were employed for data analyses. Data will be 
analyzed on a per protocol basis given that the goal of this pilot. Baseline 
characteristics will be compared between groups using unpaired t-tests, chi-

square, or Fisher’s Exact test as. Differences in step counts and pedometer 
determine active time over the study period will be investigated using general 
linear models for repeated measures with the randomization group 
assignment as the between subjects variable and a three factor within subjects 
comparisons representing the three measurement time points with the Tukey 
test applied for post-hoc comparisons if significance of the overall models was 
detected. Correlations between step count measurements and PDAH 
measurements were performed using Pearson’s r test. P < 0.05 were 
considered significant.