Stroke Volume at Rest and During Exercise in Healthy Volunteers
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Sep 2025
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2025
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedFirst Posted
Study publicly available on registry
January 6, 2026
CompletedJanuary 6, 2026
January 1, 2026
3 months
August 31, 2025
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Between-day smallest real difference (SRD) for stroke volume during upright rest
2-10 days
Between-day coefficient of variance (CV) for for stroke volume during upright rest
2-10 days
Secondary Outcomes (4)
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
Between-day CV for stroke volume at 60% of Wmax during CPET
2-10 days
Other Outcomes (52)
Between-day SRD for stroke volume at 40% of Wmax during CPET
2-10 days
Between-day CV for stroke volume at 40% of Wmax during CPET
2-10 days
Between-day SRD for stroke volume at 80% of Wmax during CPET
2-10 days
- +49 more other outcomes
Study Arms (1)
Exercise bout
EXPERIMENTALA cardiopulmonary exercise test (CPET), during which stroke volume and heart rate are continuously measured
Interventions
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).
Eligibility Criteria
You may qualify if:
- Men and women
- years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Trygfondens Center for Aktiv Sundhed
Copenhagen, 2100, Denmark
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD DMSc
Study Record Dates
First Submitted
August 31, 2025
First Posted
January 6, 2026
Study Start
September 1, 2025
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
January 6, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share