Trial Outcomes & Findings for A Study of Physical Activity paTTerns and Major Health Events in Older People With Implantable Cardiac Devices (NCT NCT03544424)
NCT ID: NCT03544424
Last Updated: 2025-05-21
Results Overview
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.
COMPLETED
183 participants
Retrospective: 12 months prior to enrolment (retrospective data spans 12 months prior to enrolment)
2025-05-21
Participant Flow
Participant milestones
| Measure |
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: No intervention
|
|---|---|
|
Overall Study
STARTED
|
183
|
|
Overall Study
COMPLETED
|
183
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Physical Activity paTTerns and Major Health Events in Older People With Implantable Cardiac Devices
Baseline characteristics by cohort
| Measure |
Study Cohort
n=183 Participants
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: No intervention
|
|---|---|
|
Age, Continuous
|
73 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
183 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
183 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Retrospective: 12 months prior to enrolment (retrospective data spans 12 months prior to enrolment)Population: People over 60 years with compatible implanted cardiac device
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.
Outcome measures
| Measure |
Low Activity
n=33 Participants
Participants with mean physical activity \<1 hour per day
|
Medium/High Activity
n=107 Participants
Participants with mean physical activity \>1 hour per day
|
|---|---|---|
|
Non-elective Hospital Admissions
Non-elective hospitalisation
|
2 Participants
|
3 Participants
|
|
Non-elective Hospital Admissions
No non-elective hospitalisation
|
31 Participants
|
104 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 140 participants had adequate activity data from devices
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.
Outcome measures
| Measure |
Low Activity
n=140 Participants
Participants with mean physical activity \<1 hour per day
|
Medium/High Activity
Participants with mean physical activity \>1 hour per day
|
|---|---|---|
|
Frailty
Frailty
|
16 Participants
|
—
|
|
Frailty
Pre-frailty
|
74 Participants
|
—
|
|
Frailty
Not frail
|
50 Participants
|
—
|
Adverse Events
Study Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place