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临床试验/NCT05193175
NCT05193175招募中不适用

Effects of Breaking up Sitting Time on Cardiometabolic Risk Markers and Cardiac Function Post Myocardial Infarction

University of Bedfordshire2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年11月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
18
试验地点
2
主要终点
Posterior wall thickness

研究概览

简要总结

Cardiovascular Disease (CVD) is one of the greatest causes of mortality and morbidity globally, particularly in middle to high income countries. In the UK alone, it was accountable for 124,641 deaths in 2017. Further to this, CVD contributes to a vast economic burden, costing the National Health Service (NHS) £19billion annually. This is mainly due to a significant number of hospital readmissions following a first cardiac event (198,000 per annum).

Following a cardiac event, an individual is therefore recommended to reduce their risk factors, including lipid profile, smoking status and physical inactivity, to reduce their risk of a secondary event. In healthy individuals, regularly breaking up sitting time reduces cardiometabolic risk markers. The aim of this study is to therefore observe if this effect is replicated in the cardiac population and thus whether breaking up sitting time will reduce the risk of a secondary cardiac event.

Potential participants will be required to meet an inclusion criteria to take part in the study: aged 50 years or above and had a myocardial infarction within the past three months at the time of recruitment to the study.

Participants will be randomised to each condition: 1) uninterrupted sitting; 2) sitting with intermittent standing and 3) sitting with intermittent light physical activity (stepping to a metronome beat). A number of physiological markers will be measured before, during and after each condition and analysed to compare the effectiveness of each condition.

All measurements will be taken at the University of Bedfordshire Sport and Exercise Science Laboratories.

详细描述

Study design A repeated measures, randomised cross over study design will be used. All data collection will take place at the Sport and Exercise Science Laboratories, University of Bedfordshire, Polhill Avenue, Bedford, UK. After a preliminary testing session, participants will complete three, 6-hour experimental conditions in a random order: 1) uninterrupted sitting; 2) sitting interrupted with standing breaks, and 3) sitting interrupted with light intensity stepping breaks. There will be a washout period of at least 72 hours between conditions, as previous research suggests that a single session of exercise can affect blood glucose levels for the following 48 hours (Mikines, et al., 1988). Participants will be randomised to order of condition using computer generated random numbers. This will assign them a trial order using block randomization with balanced block sizes. Participants will be blinded to the trial condition until they arrive on the day of their first and second experimental conditions.

Preliminary testing Patients will first attend a preliminary testing session where they will become accustomed to light intensity stepping on the spot to the beat of a metronome and use of the Borg RPE scale. This will ensure patients are familiar with an intensity that is equivalent to an RPE of 8-11 (very light to light) that will be used in the respective experimental condition. Participants will step to different metronome paces starting at a slow pace and building up gradually every 1-2 minutes until an RPE of 8-11 is found. This imitates the intensity recommended within the warm up of CR, as recommended by BACPR. Height (cm) and weight (kg) will also be measured using a stadiometer (Harpenden 98.602, Holtain Ltd., Crymych) and digital scales (Tanita BWB0800, Tanita Corp., Tokyo, Japan) respectively, to calculate body mass index (kg/m2).

Experimental Protocol Participants will be asked to refrain from any alcohol and caffeine for 24 hours prior to each visit, as well as avoid exercise for 72 hours and complete an overnight fast. This will be explained to them during the preliminary visit. To monitor this, they will be asked prior to participation per visit whether they have fasted/ when they last ate and drank.

Participants will be asked to perform an overnight fast for at least 10 hours before arrival and minimise active travel to the laboratory (e.g. use a car for travel). They will rest for 30 minutes to achieve a steady state before baseline blood pressure (two measures with 2 minutes rest between each and the average taken) and blood samples are taken. Baseline cardiac function measures (global strain, ejection fraction and systolic volume) will be measured using an echocardiogram scan, as well as an electrocardiogram (ECG) to ensure there are no electrical contraindications to the heart which would make the participant unsuitable to complete the study intervention including ST depression / elevation or any arrythmias. Baseline mood and wellbeing measures will then be assessed using questionnaires.

Following baseline measures, a standardised breakfast will be consumed (see meals section below) and participants will then commence the experimental condition. See Figure 1 for schematic of experimental conditions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • Patients post myocardial infarction (ST wave elevated MI or Non-ST wave elevated MI) within the past three months (confirmed by elevated blood biomarkers or electrocardiographic changes), in which the procedure/ recovery uncomplicated and are therefore classified as low risk.
  • Aged 40 years or above.
  • Any ethnicity.
  • Individuals with diet controlled type 2 diabetes mellitus

排除标准

  • Previous MI
  • Under 40 years of age.
  • Unable to provide valid informed consent (lack of mental capacity).
  • Not had a cardiac event diagnosed within the past three months.
  • Existing comorbidities including cancer, chronic kidney disease and gastro-oesophageal diseases.
  • Unstable coronary disease.
  • Diagnosed diabetes and use of medication.
  • Disease or conditions with a prognosis of less than 6 months to end of life (palliative care). Any known blood borne disease.
  • Unable to stand and engage in light-intensity stepping.

结局指标

主要结局

Posterior wall thickness

时间窗: 4 months

Posterior wall thickness in cm

Left ventricular internal diameter

时间窗: 4 months

Left ventricular internal diameter in cm

E wave

时间窗: 4 months

E wave in ms

Aortic root

时间窗: 4 months

Aortic root in cm

A wave

时间窗: 4 months

A wave in ms

End volume

时间窗: 4 months

End volume in cm

Interventricular septum

时间窗: 4 months

Interventricular septum in cm

Isovolumetric relaxation time

时间窗: 4 months

Isovolumetric relaxation time in ms

Stroke volume

时间窗: 4 months

Stroke volume in L

Relative wall thickness

时间窗: 4 months

Relative wall thickness in cm

Left ventricular mass

时间窗: 4 months

Left ventricular mass in g

E/A ratio

时间窗: 4 months

E/A ratio

Deceleration time

时间窗: 4 months

Deceleration time in ms

Ejection fraction

时间窗: 4 months

Ejection fraction in %

次要结局

  • Diastolic Blood pressure(4 months)
  • Postprandial triglycerides(4 months)
  • Systolic Blood pressure(4 months)
  • Postprandial low density lipoprotein cholesterol(4 months)
  • Mood and wellbeing(4 months)
  • Postprandial total cholesterol(4 months)
  • Postprandial high density lipoprotein cholesterol(4 months)
  • Postprandial insulin(4 months)
  • Postprandial glucose(4 months)

研究者

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

Abbie C. Bell

PhD Candidate

University of Bedfordshire

研究点 (2)

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