Physical Activity and Pacemaker Study

NCT03052829 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-09-19

Study results available
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Summary

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.

Conditions

Interventions

BEHAVIORAL

Physical activity counseling

Subjects in this arm will receive counseling on how to increase their physical activity level.

BEHAVIORAL

Usual care

Subjects will undergo their usual care without intervention

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY
  • University of Wisconsin, Milwaukee

    collaborator OTHER
  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Michael Widlansky, MD · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2019-01-14
Completion
2019-07-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03052829 on ClinicalTrials.gov