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An observational study of physical activity patterns in 150 older adults with cardiac implantable electronic devices (CIED)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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People 60 years or older with CIED in situ for at least 6 months
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| Name | Affiliation | Role |
|---|---|---|
| Adam Greenstein, MBChB, PhD | Manchester University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manchester Heart Centre | Manchester | M13 9WL | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | People over 60 years with compatible implanted cardiac device | Posted | Count of Participants | Participants | Retrospective: 12 months prior to enrolment (retrospective data spans 12 months prior to enrolment) |
|
1 day
No prospective follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Joanne Taylor | University of Manchester | 0161 306 6000 | joanne.taylor-2@manchester.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2018 | May 7, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D002318 | Cardiovascular Diseases |
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| 30 days |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | 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. | 140 participants had adequate activity data from devices | Posted | Count of Participants | Participants | 30 days |
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| 183 |
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| 183 |
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