N/A
N=21
Physical Activity and Pacemaker Study
Physical Activity · Pacemaker · Cardiovascular Diseases · Arrythmia
Bottom Line
View on ClinicalTrials.gov: NCT03052829 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Physical Activity Level as Measured by Embedded Accelerometer — 1.97; 1.77 active hours/day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Physical activity counseling (Behavioral); Usual care (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physical Activity Level as Measured by Embedded Accelerometer |
1.97; 1.77 | — |
| SECONDARY Physical Activity Level as Measured by External Pedometer |
1769; 2487 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03052829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.