Physical ActivityPATTErnNCT03544424
A Study of Physical Activity paTTerns and Major Health Events in Older People With Implantable Cardiac Devices
An observational study of Physical Activity and Aging, run by University of Manchester at 1 site in United Kingdom.
Trial summary
An observational study of physical activity patterns in 150 older adults with cardiac implantable electronic devices (CIED) Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Physical Activity, Aging, Cardiac Disease
- How many people
- 183 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Oct 2018to 9 Nov 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People 60 years or older with CIED in situ for at least 6 months
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
An observational study of physical activity patterns in 150 older adults with cardiac implantable electronic devices (CIED)
Read the detailed 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
- Conditions
- Physical Activity, Aging, Cardiac Disease
- Being tested
- No intervention
- Medical subject headings
- Motor Activity, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Retrospective: 12 months prior to enrolment (retrospective data spans 12 months prior to enrolment)
Secondary outcomes (1)
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start12 Oct 2018
- Primary completion3 Jul 2019
- Study completion9 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Joanne Taylor, University of Manchester
- Investigators
- Adam Greenstein, MBChB, PhD, Study director, Manchester University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544424
- Sponsor's protocol ID
- 215964
- Acronym
- PATTErn
- Status last verified
- May 2025
- First submitted
- 21 May 2018
- Last updated
- 21 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Physical Activity paTTerns and Major Health Events in Older People With Implantable Cardiac Devices
- ClinicalTrials.gov ID
- NCT03544424
- Acronym / sponsor ID
- PATTErn / 215964
- Conditions
- Physical Activity, Aging, Cardiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Posted 21 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational study of physical activity patterns in 150 older adults with cardiac implantable electronic devices (CIED)
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Other: No interventionPeople over 60 years of age with a Medtronic CareLink® compatible CIED in situ recruited from the Manchester University NHS Foundation Trust, England, UK |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People 60 years or older with CIED in situ for at least 6 months
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Study cohort |
Primary outcome
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.
1 secondary outcome
Frailty
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Greenstein, MBChB, PhD study director
Manchester University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity and Aging, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-elective Hospital Admissions (time frame: Retrospective: 12 months prior to enrolment (retrospective data spans 12 months prior to enrolment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.