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

May 19, 2025 updated by: Dr Joanne Taylor, University of Manchester
An observational study of physical activity patterns in 150 older adults with cardiac implantable electronic devices (CIED)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

183

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Manchester Heart Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Retrospective: 12 months prior to enrolment (retrospective data spans 12 months prior to enrolment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty
Time Frame: 30 days

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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Investigators

  • Study Director: Adam Greenstein, MBChB, PhD, Manchester University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2018

Primary Completion (Actual)

July 3, 2019

Study Completion (Actual)

November 9, 2020

Study Registration Dates

First Submitted

May 21, 2018

First Submitted That Met QC Criteria

May 21, 2018

First Posted (Actual)

June 1, 2018

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 215964

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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