Physical Activity and Pacemaker Study

NCT03052829 | Completed Results

• 1 other identifier: PRO27994
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity; Pacemaker; Cardiovascular Diseases; Arrythmia

Outcome Measures

Primary Outcomes (1)

• Physical Activity Level as Measured by Embedded Accelerometer

  This is the daily measured active hours in the device

  6 months

Secondary Outcomes (1)

• Physical Activity Level as Measured by External Pedometer

  6 months

Study Arms (2)

Physical Activity Counseling

EXPERIMENTAL

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

Patient Usual Care

PLACEBO COMPARATOR

Subjects will undergo usual care without intervention in this study arm

Behavioral: Usual care

Interventions

Physical activity counseling BEHAVIORAL

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

Physical Activity Counseling

Usual care BEHAVIORAL

Subjects will undergo their usual care without intervention

Patient Usual Care

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Medtronic: collaborator
• University of Wisconsin, Milwaukee: collaborator

Study Sites (1)

Medical College of Wisconsin and Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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.

  PMID: 32375676 DERIVED

MeSH Terms

Conditions

Motor Activity; Cardiovascular Diseases; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Behavior; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Unable to complete projected enrollment due to difficulties with recruitment

Results Point of Contact

• Title: Amberly Anger
• Organization: Medical College of Wisconsin

aanger@mcw.edu

414-955-6708

Study Officials

• Michael Widlansky, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Pharmacology

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 14, 2017
• Study Start: March 1, 2017
• Primary Completion: January 14, 2019
• Study Completion: July 1, 2019
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)