Physical ActivityNCT03052829
Physical Activity and Pacemaker Study
A study testing Physical activity counseling in people with Physical Activity and Pacemaker, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Physical Activity, Pacemaker, Cardiovascular Diseases
- What is being tested?
- Physical activity counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin and Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
About this study
Official title: Reducing Sedentary Time in Individuals With Pacemakers - Tracking By Pacemaker-Based Accelerometry
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.
Read the 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:
- 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.
- 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
- Being tested
- Physical activity counseling, Usual care
- Medical subject headings
- Motor Activity, Cardiovascular Diseases, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity counselingBehavioural
Subjects in this arm will receive counseling on how to increase their physical activity level.
Usual careBehavioural
Subjects will undergo their usual care without intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Physical activity counseling |
| Patient Usual Care | Placebo comparator | Subjects will undergo usual care without intervention in this study arm Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Level as Measured by Embedded Accelerometer
This is the daily measured active hours in the device
Measured: 6 months
Secondary outcomes (1)
Physical Activity Level as Measured by External Pedometer
this is a daily step count (one week average)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start1 Mar 2017
- Primary completion14 Jan 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, University of Wisconsin, Milwaukee
- Responsible party
- Principal investigator, Michael E. Widlansky, Medical College of Wisconsin
- Investigators
- Michael Widlansky, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052829
- Sponsor's protocol ID
- PRO27994
- Status last verified
- May 2024
- First submitted
- 10 Feb 2017
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Step-count data from the pedometers that the subjects wear along with the activity level as measured by the subject's pacemaker will be shared with the collaborating researchers at Medtronic and at UW-Milwaukee. This data will be obtained via phone conversations with the subject and via in-clinic or remote interrogations of the implanted pacemakers. The data will become available on an ongoing basis during the study duration as participants are contacted per the study protocol.
Publications
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.
PubMed 32375676
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Sedentary Time in Individuals With Pacemakers - Tracking By Pacemaker-Based Accelerometry
- ClinicalTrials.gov ID
- NCT03052829
- Acronym / sponsor ID
- PRO27994
- Conditions
- Physical Activity, Pacemaker, Cardiovascular Diseases, Arrythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Medtronic, University of Wisconsin, Milwaukee
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Counseling | Experimental | Behavioral: Physical activity counselingSubjects 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. |
| Patient Usual Care | Placebo comparator | Behavioral: Usual careSubjects will undergo usual care without intervention in this study arm |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity counselingSubjects in this arm will receive counseling on how to increase their physical activity level. | Behavioural | Physical Activity Counseling |
| Usual careSubjects will undergo their usual care without intervention | Behavioural | Patient Usual Care |
Primary outcome
Physical Activity Level as Measured by Embedded Accelerometer
Time frame: 6 months
This is the daily measured active hours in the device
1 secondary outcome
Physical Activity Level as Measured by External Pedometer
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32375676Puppala 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.
- Individual participant dataSharing planned: Yes. Step-count data from the pedometers that the subjects wear along with the activity level as measured by the subject's pacemaker will be shared with the collaborating researchers at Medtronic and at UW-Milwaukee. This data will be obtained via phone conversations with the subject and via in-clinic or remote interrogations of the implanted pacemakers. The data will become available on an ongoing basis during the study duration as participants are contacted per the study protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Widlansky, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity counseling in people with Physical Activity and Pacemaker, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Level as Measured by Embedded Accelerometer (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03052829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.