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Completed

NCT Number: NCT03544424

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

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Manchester Heart Centre

Manchester, M13 9WL, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Acronym: PATTErn

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 1, 2018
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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