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

NCT03544424 | Completed Results

• 1 other identifier: 215964
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Physical Activity; Aging; Cardiac Disease

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Frailty

  30 days

Study Arms (1)

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

Interventions

No intervention OTHER

No intervention

Study cohort

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Manchester Heart Centre

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity; Heart Diseases

Condition Hierarchy (Ancestors)

Behavior; Cardiovascular Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr Joanne Taylor
• Organization: University of Manchester

joanne.taylor-2@manchester.ac.uk

0161 306 6000

Study Officials

• Adam Greenstein, MBChB, PhD

  Manchester University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow in Cardiology, Postgraduate Student

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 1, 2018
• Study Start: October 12, 2018
• Primary Completion: July 3, 2019
• Study Completion: November 9, 2020
• Last Updated: May 21, 2025
• Results First Posted: May 21, 2025

Record last verified: 2025-05

Locations

GB (1)