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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

183 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-12

Study Completion Date

2020-11-09

Brief Summary

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

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Detailed Description

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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

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Physical Activity Aging Cardiac Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No