CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Physical activity counseling +1 morebehavioral
Likely dose
Not stated in record
Key inclusion· 6
  • Age greater than 55 years
  • Clinical indication for permanent pacemaker placement
  • Left ventricular ejection fraction ≥50% at implantation or within 72 hours
  • Able to ambulate
Key exclusion· 3
  • Follow-up implantation care planned at non-study center
  • Expected life span of 1 year or less at time of implantation
  • Known history of cognitive impairment or inability to follow study procedures

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03052829
NCT03052829N/ACompleted

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

Medical College of Wisconsin·interventional·Posted Feb 14, 2017·Updated Sep 19, 2024

In Brief

A clinical study evaluating Physical activity counseling and Usual care for Physical Activity and 3 related conditions. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 14, 2017
Enrollment StartMar 1, 2017
Primary CompletionJan 14, 2019
Study CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.4 years ago

Interventions

Physical activity counselingbehavioral

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

Usual carebehavioral

Subjects will undergo their usual care without intervention