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

University of Manchester183 enrolled

Overview

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

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

183

Conditions

Physical Activity Aging Cardiac Disease

Interventions

No interventionOTHER

No intervention

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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)

Locations (1)

Manchester Heart Centre

Manchester, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: Retrospective: 12 months prior to enrolment (retrospective data spans 12 months prior to enrolment)

Secondary Outcomes

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.

Time frame: 30 days

Data from ClinicalTrials.gov

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