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临床试验/NCT03544424
NCT03544424已完成不适用

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

University of Manchester1 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2018年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
183
试验地点
1
主要终点
Non-elective Hospital Admissions

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Non-elective Hospital Admissions

时间窗: 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.

次要结局

  • Frailty(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Joanne Taylor

Clinical Fellow in Cardiology, Postgraduate Student

University of Manchester

研究点 (1)

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