A Study of Physical Activity paTTerns and Major Health Events in Older People With Implantable Cardiac Devices

An observational study of Physical Activity and Aging, run by University of Manchester at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

An observational study of physical activity patterns in 150 older adults with cardiac implantable electronic devices (CIED) Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Physical Activity, Aging, Cardiac Disease
How many people: 183 participants
Where: 1 siteUnited Kingdom
Study dates: 12 Oct 2018to 9 Nov 2020
Phase: Observational
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 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: People 60 years or older with CIED in situ for at least 6 months

Who may be able to join

Age 60+ years
Functioning CIED in situ for at least 6 months
Medtronic manufactured device compatible with CareLink® Cardiac Compass application (platform which measures and stores physiological parameters)
Lives in the Greater Manchester area
Able and willing to given written, informed consent to enter the study

Who cannot join

Faulty or incompatible device
Immobile (unable to walk in upright position)
Active participant in a clinical trial which does not allow concurrent recruitment into this study
People unable to consent in the English language (including the understanding of study literature which is published in English only)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Manchester Heart Centre
Manchester, M13 9WL

Other trials in United Kingdom

About this study

An observational study of physical activity patterns in 150 older adults with cardiac implantable electronic devices (CIED)

Read the detailed description

Study Type: observational, investigator led Study Design: observational model: cohort (retrospective) Population: 150 people over 60 years of age with a Medtronic CareLink® compatible CIED in situ recruited from the Manchester University NHS Foundation Trust, England, UK Data collection: daily PA measures, demographic details, co-morbidity status, physical frailty assessment, functional status, quality of life (QOL) and NEHA data Consent: for participation in the study, physical frailty assessment, additional collection of retrospective CIED data, and access to electronic patient records Data sources: CIED downloads, self-report questionnaire, physical measurements (height, weight, hand grip strength, gait speed), electronic hospital records, HES (hospital episode statistics) data Results analysis: data will be analysed to investigate: daily PA variability; the association between PA and NEHAs, and the impact of frailty on PA patterns

Conditions: Physical Activity, Aging, Cardiac Disease
Being tested: No intervention
Medical subject headings: Motor Activity, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No interventionOther
No intervention

Study groups in NCT03544424
Study group	Role	What they receive
Study cohort		People over 60 years of age with a Medtronic CareLink® compatible CIED in situ recruited from the Manchester University NHS Foundation Trust, England, UK Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Non-elective Hospital Admissions
Non-elective hospital admissions, as defined as an emergency admission to an National Health Service (NHS) hospital within England or Wales for any reason. Data collected from NHS England.
Number of Participants With Non-elective Hospital Admissions.
Measured: Retrospective: 12 months prior to enrolment (retrospective data spans 12 months prior to enrolment)

Secondary outcomes (1)

Frailty
Frailty as per Fried criteria
Fried frailty criteria is a score between 1-5. A score of 0-1 = not frail A score of 2 = pre-frail A score of 3+ = frailty
Reference:
Fried, L. P., Tangen, C. M., Walston, J., Newman, A. B., Hirsch, C., Gottdiener, J., ... \& McBurnie, M. A. (2001). Frailty in older adults: evidence for a phenotype. The journals of gerontology series a: biological sciences and medical sciences, 56(3), M146-M157.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 20189 Nov 2020

First posted1 Jun 2018
Study start12 Oct 2018
Primary completion3 Jul 2019
Study completion9 Nov 2020

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.
Other trials for Physical ActivityStudies of the same condition, open and under way.
More trials run by University of ManchesterThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 183 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03544424
Sponsor's protocol ID: 215964
Acronym: PATTErn
Status last verified: May 2025
First submitted: 21 May 2018
Last updated: 21 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Physical Activity trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Physical Activity paTTerns and Major Health Events in Older People With Implantable Cardiac Devices
ClinicalTrials.gov ID: NCT03544424
Acronym / sponsor ID: PATTErn / 215964
Conditions: Physical Activity, Aging, Cardiac Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 183 participants (actual)
Lead sponsor: University of ManchesterUniversity, hospital or other
Study start: 12 Oct 2018 (actual)
Primary completion: 3 Jul 2019 (actual)
Study completion: 9 Nov 2020 (actual)
First posted: 1 Jun 2018 (actual)
Results: Posted 21 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

An observational study of physical activity patterns in 150 older adults with cardiac implantable electronic devices (CIED)

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Study cohort	–	Other: No interventionPeople over 60 years of age with a Medtronic CareLink® compatible CIED in situ recruited from the Manchester University NHS Foundation Trust, England, UK

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: People 60 years or older with CIED in situ for at least 6 months

Key inclusion criteria (5 listed)

Age 60+ years
Functioning CIED in situ for at least 6 months
Medtronic manufactured device compatible with CareLink® Cardiac Compass application (platform which measures and stores physiological parameters)
Lives in the Greater Manchester area
Able and willing to given written, informed consent to enter the study

Key exclusion criteria (4 listed)

Faulty or incompatible device
Immobile (unable to walk in upright position)
Active participant in a clinical trial which does not allow concurrent recruitment into this study
People unable to consent in the English language (including the understanding of study literature which is published in English only)

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
No interventionNo intervention	Other	Study cohort

Primary outcome

Non-elective Hospital Admissions
Time frame: Retrospective: 12 months prior to enrolment (retrospective data spans 12 months prior to enrolment)
Non-elective hospital admissions, as defined as an emergency admission to an National Health Service (NHS) hospital within England or Wales for any reason. Data collected from NHS England. Number of Participants With Non-elective Hospital Admissions.

1 secondary outcome

Frailty
Time frame: 30 days

Results and safety

Results posted to the registry on 21 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Cohort	183	183

Primary outcome: Non-elective Hospital Admissions

Time frame: Retrospective: 12 months prior to enrolment (retrospective data spans 12 months prior to enrolment). Count of participants. Unit: Participants

Measure	Low Activity n = 33	Medium/High Activity n = 107
Non-elective hospitalisation	2	3
No non-elective hospitalisation	31	104

Population analysed: People over 60 years with compatible implanted cardiac device

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Cohort	0 of 183 (0%)	0 of 183 (0%)	0 of 183

Limitations and caveats (from the sponsor): This was a cross-sectional study. Recruitment was limited due to COVID-19, therefore study design was adapted. The primary outcome was non-elective hospital admissions, however there were too few events to facilitate the primary analysis. Secondary outcome of the study was to investigate the association between physical activity as measured by cardiac device and frailty.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Physical Activity

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
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Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
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RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
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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.

Adam Greenstein, MBChB, PhD study director

Manchester University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Physical Activity and Aging, run by University of Manchester at 1 site in United Kingdom.

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 5 inclusion and 4 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 21 May 2025. 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 Kingdom. 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. 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 21 May 2025). 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?

Non-elective Hospital Admissions (time frame: Retrospective: 12 months prior to enrolment (retrospective data spans 12 months prior to enrolment)). 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 NCT03544424.

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 21 May 2025.