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临床试验/NCT05771610
NCT05771610尚未招募不适用

Sedentary Time in Individuals With Ischaemic Heart Disease and Its Association With Cardiac Function, Structure and Cardiovascular Risk Factors

University of Bedfordshire0 个研究点目标入组 67 人开始时间: 2023年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
67
主要终点
Daily sitting time in IHD

研究概览

简要总结

Cardiovascular Disease (CVD) is the leading cause of mortality and morbidity globally. Following a myocardial infarction (MI), an individual is at an increased risk of a secondary event (20-50% higher risk post MI), compared to those with no prior CVD. Independent of physical activity levels, high amounts of daily sitting is a risk factor for CVD, of which sitting is typically used as an indicator for sedentary behaviour. Sedentary behaviour is defined as a waking energy expenditure of less than 1.5 METs (metabolic task equivalent) while in a seated, reclined or lying posture.

Currently, there is little knowledge regarding the prevalence of sedentary behaviour ischaemic heart disease. The aim of this study is therefore to measure activity levels of an individual following a diagnosis of ischaemic heart disease, alongside its association to cardiac function and cardiovascular risk factors. Sitting patterns and physical activity will be monitored 24 h/day during each condition using an activPAL activity monitor (PAL Technologies, Glasco, Scotland). This will measure changes in posture and level of activity by cadence.

详细描述

An observational, cross-sectional study design will be used. Participants can have preliminary measures taken either during a visit to the Sport and Exercise Sciences Laboratories at the University of Bedfordshire or in their own home, depending on the participant's preference. This consists of anthropometric measures (height, weight and waist circumference). Participants will then rest for 5 minutes to achieve a steady state before baseline blood pressure is taken. Baseline cardiac function measures will be measured using an echocardiogram scan, as well as an electrocardiogram (ECG) to ensure there are no electrical contraindications to the heart (including new ST depression / elevation or any arrythmias) which would make the participant unsuitable to complete the study. Mood and wellbeing measures will then be assessed using questionnaires.

Following this, participants will be asked to complete 7 full days of normal daily activity, whilst wearing an activPAL monitor on their thigh to record sitting, standing and stepping. The main data collection will take place at the participant's home, workplace or leisure setting (i.e. under free-living conditions), with social distancing in place if required at the time of data collection. Instructions will be given to help ensure that the 7-day monitoring period reflects their usual habits. The monitoring period will also be carefully decided, to ensure it does not conflict with any events that are out of the usual for the participant, such as holidays or work-based events, which would alter their usual sedentary patterns.

Data collection

Demographic data Patient demographic data will include age, gender, diagnosis and intervention. This is routinely collected within Cardiac Rehabilitation as part of their usual standard of care.

Height and weight Equipment to measure height, weight and waist circumference will include a stadiometer (Leicester Height Scale, Marsden HM-250P, Leicester, UK) to measure height in cm, a measurement tape for waist circumference and digital weighing scales (Tanita, BWB0800, Allied Weighing, UK) to measure weight in kg.

研究设计

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

入排标准

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

入选标准

  • · Patients diagnosed with ischemic heart disease within the past 12 months (within National Audit of Cardiac Rehabilitation (NACR) outcome data). This includes post myocardial infarction (ST wave elevated MI or Non-ST wave elevated MI), post coronary artery bypass graft, post percutaneous coronary intervention.
  • Males and females
  • Aged 18 years or above.
  • Any ethnicity.

排除标准

  • · Under 18 years of age.
  • Unable to provide valid informed consent (lack of mental capacity).
  • Not had a cardiac event diagnosed within the past 12 months.
  • Unstable coronary disease.
  • Disease or conditions with a prognosis of less than 6 months to end of life (palliative care).

结局指标

主要结局

Daily sitting time in IHD

时间窗: 7 days

Measured using activpal

次要结局

  • BMI(9 months)
  • End volume(9 months)
  • Posterior wall thickness(9 months)
  • E wave(9 months)
  • E/A ratio(9 months)
  • Deceleration time(9 months)
  • Diastolic blood pressure(9 months)
  • Left ventricular internal diameter(9 months)
  • Aortic root(9 months)
  • Relative wall thickness(9 months)
  • Ejection fraction(9 months)
  • Systolic blood pressure(9 months)
  • Weight(9 months)
  • Intraventricular septum(9 months)
  • A wave(9 months)
  • Left ventricular mass(9 months)
  • Isovolumetric relaxation time(9 months)
  • Stroke volume(9 months)
  • Height(9 months)
  • Hospital anxiety and depression score(9 months)

研究者

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

Abbie C. Bell

Principal Investigator

University of Bedfordshire

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