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临床试验/NCT05356871
NCT05356871已完成不适用

Validity and Reliability of a Clinical Method for Assessment of Cardiorespiratory Fitness Using Seismocardiography

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年6月29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
20
试验地点
1
主要终点
Validity and reliability of the SCG VO2max prediction model

研究概览

简要总结

Measurement of cardiorespiratory fitness (here VO2max) is considered a valuable tool for improving the risk prediction of cardiovascular disease and overall patient management. However, the gold standard method for determining VO2max requires both maximal exercise until exhaustion and expensive equipment, why it is not always feasible. A new method for estimating VO2max using a non-exercise prediction model with seismocardiography (SCG) information has been proposed. SCG is recording and interpretations of vibrations originating from the beating heart measured on the chest wall with an accelerometer. SCG has previously been shown to correlate to physiologic events in the cardiac cycle and thus a measure of cardiac performance. VO2max is generally believed to be limited by the rate of oxygen delivery to the muscles, where maximal cardiac output and oxygen carrying capacity of the blood are considered the main limiting factors. The theoretical basis for incorporating SCG to a VO2max prediction model is therefore evident. The previous studies assessed the prediction model in a cross-sectional study design to compare validity of the method. A requirement of further validation of the prediction model with reliability assessment is therefore needed.

Biological age is a concept trying to relate the age to the health status rather than the date of birth. Biological age assesses the heterogeneity in functional metabolic status and vulnerability to disease. A Biological age model has previously been designed for health promotion interventions. However, reliability assessment of the model is needed.

The purpose of the current study was therefore to:

  1. investigate the validity and reliability of a new clinical method for estimation of maximal oxygen consumption (VO2max) using seismocardiography.
  2. investigate the reliability of the biological age model.

详细描述

20 healthy participants were recruited for the study. The study included three identical visit to the laboratory within 14 days.

The participants received both written and oral information about the study and the possible risks associated hereof, before volunteering and signing a written informed consent form.

The participants arrived at the laboratory after an overnight fast from latest 10pm the day before (water excepted). Furthermore, the participants were asked to avoid strenuous exercise 48 hours prior to the test day and eat a habitual diet, which had to be replicated before the second and third visit.

Testing at each visit to the laboratory included:

Completion of a short version of the International Physical Activity Questionaire, about leisure time physical activities.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy participants

排除标准

  • A history of previous or current cardiovascular disease
  • Pregnancy
  • Conditions that prevent maximal cycling exercise

结局指标

主要结局

Validity and reliability of the SCG VO2max prediction model

时间窗: From June until December

For assessment of validity and reliability of the SCG VO2max prediction model, three repeated measures of SCG VO2max and the gold standard determination of VO2max will be conducted on three different test days within 14 days. The validity assessment will be based on differences and agreement between the two methods. The reliability assessment will be based on intra-method variations between test days.

次要结局

  • Reliability of the biological age model(From June until December)

研究者

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

Jørn Wulff Helge

Professor

University of Copenhagen

研究点 (1)

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