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临床试验/NCT07318844
NCT07318844已完成不适用

Stroke Volume at Rest and During Exercise in Healthy Volunteers

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Between-day smallest real difference (SRD) for stroke volume during upright rest

研究概览

简要总结

Background Changes in cardiac output, driven by increased heart rate and stroke volume, are crucial for oxygen delivery during acute exercise and influence maximal oxygen uptake (VO₂max). Thoracic electrical bioimpedance provides a non-invasive alternative to traditional invasive methods by estimating stroke volume through impedance changes during ventricular filling and emptying. However, its test-retest reliability remains uncertain, requiring further investigation for use in acute and long-term training assessments.

Methods Inclusion: 12 healthy individuals (six males, six females) Exclusion: Known ischaemic heart disease, known heart failure, symptoms of disease within 2 weeks prior to the study, known malignant disease, claudication, pregnancy, unstable cardiac arrhythmic disease, renal or liver dysfunction, known chronic lung disease Design: Test-retest study of thoracic electrical bioimpedance-based stroke volume

Intervention: Acute exercise bout on a bicycle ergometer Statistical design: Rest-to-exercise changes, as well as between-day smallest real difference, coefficient of variation and intraclass correlation coefficient Sample size: Since this is a pilot study, the sample size is set at 12 in accordance with current recommendations.

Perspective The results are relevant for designing future studies in which stroke volume is measured and compared in response to various interventions at rest and during exercise.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women
  • 18-70 years

排除标准

  • Known chronic lung disease
  • Known ischaemic heart disease
  • Known heart failure
  • Symptoms of disease within 2 weeks prior to the study
  • Known malignant disease
  • Claudication
  • Pregnancy
  • Unstable cardiac arrhythmic disease
  • Renal or liver dysfunction

结局指标

主要结局

Between-day smallest real difference (SRD) for stroke volume during upright rest

时间窗: 2-10 days

Between-day coefficient of variance (CV) for for stroke volume during upright rest

时间窗: 2-10 days

次要结局

  • Between-day CV for stroke volume at 60% of Wmax during CPET(2-10 days)
  • Between-day smallest real difference (SRD) for stroke volume during supine rest(2-10 days)
  • Between-day coefficient of variance (CV) for stroke volume during supine rest(2-10 days)
  • Between-day SRD for stroke volume at 60% of maximal workload (Wmax) during CPET(2-10 days)

研究者

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

Ronan Berg

Professor, MD DMSc

Rigshospitalet, Denmark

研究点 (1)

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