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

Aging Clinical Trial

— PATTErn  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03544424
• Other study ID #: 215964
• Status: Recruiting
• Start date: October 12, 2018
• Est. completion date: April 12, 2020

Study information

• Verified date: October 2018
• Source: University of Manchester
• Contact: Dr Taylor, MBChB
• Phone: 0161 306 0679
• Email: joanne.taylor-2[@]manchester.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 12, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aging
• Cardiac Disease
• Heart Diseases
• Physical Activity

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
United Kingdom	Manchester Heart Centre	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-elective hospitalisation episodes	All cause	Retrospective, previous 400 days