- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07318844
Stroke Volume at Rest and During Exercise in Healthy Volunteers
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2100
- Trygfondens Center for Aktiv Sundhed
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria
- Men and women
- 18-70 years
Exclusion criteria
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Exercise bout
A cardiopulmonary exercise test (CPET), during which stroke volume and heart rate are continuously measured
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The two study days are identical, and consist of stroke volume, heart rate and non-invasive blood pressure measurements during upright rest, in the supine position, and during incremental exercise (CPET).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Between-day smallest real difference (SRD) for stroke volume during upright rest
Time Frame: 2-10 days
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2-10 days
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Between-day coefficient of variance (CV) for for stroke volume during upright rest
Time Frame: 2-10 days
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2-10 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Between-day smallest real difference (SRD) for stroke volume during supine rest
Time Frame: 2-10 days
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2-10 days
|
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Between-day coefficient of variance (CV) for stroke volume during supine rest
Time Frame: 2-10 days
|
2-10 days
|
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Between-day SRD for stroke volume at 60% of maximal workload (Wmax) during CPET
Time Frame: 2-10 days
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2-10 days
|
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Between-day CV for stroke volume at 60% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Between-day SRD for stroke volume at 40% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
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Between-day CV for stroke volume at 40% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day SRD for stroke volume at 80% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day CV for stroke volume at 80% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day SRD for stroke volume at Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day CV for stroke volume at Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
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Between-day intraclass correlation coefficient (ICC) for stroke volume during upright rest
Time Frame: 2-10 days
|
2-10 days
|
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Between-day ICC for stroke volume during supine rest
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day ICC for stroke volume at 60% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day ICC for stroke volume at 40% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day ICC for stroke volume at 80% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day ICC for stroke volume at Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day SRD for cardiac output (measured as the product of stroke volume and heart rate) during upright rest
Time Frame: 2-10 days
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2-10 days
|
|
Between-day CV for for cardiac output during upright rest
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day ICC for for cardiac output during upright rest
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day SRD for cardiac output during supine rest
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day CV for for cardiac output during supine rest
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day ICC for for cardiac output during supine rest
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day SRD for cardiac output at 60% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day CV for cardiac output at 60% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day ICC for cardiac output at 60% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day SRD for cardiac output at 40% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day CV for cardiac output at 40% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day ICC for cardiac output at 40% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day SRD for cardiac output at 80% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day CV for cardiac output at 80% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day ICC for cardiac output at 80% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day SRD for cardiac output at Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day CV for cardiac output at Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day ICC for cardiac output at Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day SRD for heart rate (measured with the CPET equipment) during upright rest
Time Frame: 2-10 days
|
2-10 days
|
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Between-day CV for for heart rate during upright rest
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day ICC for for heart rate during upright rest
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day SRD for heart rate during supine rest
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day CV for for heart rate during supine rest
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day ICC for for heart rate during supine rest
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day SRD for heart rate at 60% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day CV for heart rate at 60% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day ICC for heart rate at 60% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day SRD for heart rate at 40% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day CV for heart rate at 40% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day ICC for heart rate at 40% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day SRD for heart rate at 80% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day CV for heart rate at 80% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day ICC for heart rate at 80% of Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day SRD for heart rate at Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
|
Between-day CV for heart rate at Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
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Between-day ICC for heart rate at Wmax during CPET
Time Frame: 2-10 days
|
2-10 days
|
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Uright-to supine changes in stroke volume, heart-rate and cardiac output and arterial blood pressure at rest
Time Frame: 2-10 days
|
2-10 days
|
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Changes in stroke volume from upright rest to exercise at 40%, 60%, 80% and 100% of Wmax.
Time Frame: 2-10 days
|
2-10 days
|
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Changes in cardiac output from upright rest to exercise at 40%, 60%, 80% and 100% of Wmax.
Time Frame: 2-10 days
|
2-10 days
|
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Changes in arterial blood pressure from upright rest to exercise at 40%, 60%, 80% and 100% of Wmax.
Time Frame: 2-10 days
|
2-10 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-25024676
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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