Physical Activity and Pacemaker Study

NCT ID: NCT03052829

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-07-01

Brief 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.

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.

Conditions

Physical Activity; Pacemaker; Cardiovascular Diseases; Arrythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical activity counseling

Intervention Type: BEHAVIORAL

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

Patient Usual Care

Subjects will undergo usual care without intervention in this study arm

Group Type: PLACEBO_COMPARATOR

Usual care

Intervention Type: BEHAVIORAL

Subjects will undergo their usual care without intervention

Interventions

Physical activity counseling

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

Intervention Type: BEHAVIORAL

Usual care

Subjects will undergo their usual care without intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

University of Wisconsin, Milwaukee

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Michael E. Widlansky

Associate Professor of Medicine and Pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Widlansky, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Medical College of Wisconsin and Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32375676 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PRO27994

Identifier Type: -

Identifier Source: org_study_id