Physical Activity and Pacemaker Study

Reducing Sedentary Time in Individuals With Pacemakers - Tracking By Pacemaker-Based Accelerometry

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Physical Activity; Arrythmia; Pacemaker
• Intervention / Treatment: Behavioral: Physical activity counseling; Behavioral: Usual care

Detailed Description

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:

1. a 12 week intervention to increase moderate intensity physical activity delivered at the point of care in patients with pacemakers will result in parallel increases in active time as measured by the pacemaker and step count as measured by pedometer.
2. the increase in activity measured by both the metrics in hypothesis 1 will be greater than with usual care.

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin and Froedtert Memorial Lutheran Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 55 years old
• Clinical indication for placement of permanent pacemaker
• LVEF of ≥ 50% at the time of or within 72 hours of implantation.
• Able to ambulate
• Average active time of ≤ 2 hours/day based on Revo or EnRhythm Accelerometery read out for the 3 month period prior to enrollment
• Able to take 650 steps over 10 minutes following pacemaker implantation (~2-2.5 mph walking speed)

Exclusion Criteria:

• Follow up for implantation planned at a non-study center at the time of implantation.
• Individuals with and expected life span of 1 year or less at the time of implantation
• Known history of cognitive impairment or inability to follow study procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Physical activity counseling; Subjects in this arm will receive counseling on how to increase their physical activity level.
Placebo Comparator: Patient Usual Care; Subjects will undergo usual care without intervention in this study arm	Behavioral: Usual care; Subjects will undergo their usual care without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
increase in physical activity level as measured by embedded accelerometer	This is the daily measured active minutes in the device	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
increase in physical activity level as measured by external pedometer	this is a daily step count	6 months

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Medtronic; University of Wisconsin, Milwaukee
• Investigators: Principal Investigator: Michael Widlansky, MD, Medical College of Wisconsin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): January 14, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: February 10, 2017
• First Submitted That Met QC Criteria: February 10, 2017
• First Posted (Actual): February 14, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: PRO27994

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No