HealthyNCT07318844
Stroke Volume at Rest and During Exercise in Healthy Volunteers
A study testing Cardiopulmonary exercise test in people with Healthy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cardiopulmonary exercise test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women
- 18-70 years
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy
- Unstable cardiac arrhythmic disease
- Renal or liver dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
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
Read more
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.
- Conditions
- Healthy
- Being tested
- Cardiopulmonary exercise test
- Keywords
- stroke volume, test-retest, Acute exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise testOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Exercise bout | Experimental | A cardiopulmonary exercise test (CPET), during which stroke volume and heart rate are continuously measured Receives: Other: Cardiopulmonary exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-day smallest real difference (SRD) for stroke volume during upright rest
Measured: 2-10 days
Between-day coefficient of variance (CV) for for stroke volume during upright rest
Measured: 2-10 days
Secondary outcomes (4)
Between-day smallest real difference (SRD) for stroke volume during supine rest
Measured: 2-10 days
Between-day coefficient of variance (CV) for stroke volume during supine rest
Measured: 2-10 days
Between-day SRD for stroke volume at 60% of maximal workload (Wmax) during CPET
Measured: 2-10 days
Between-day CV for stroke volume at 60% of Wmax during CPET
Measured: 2-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Sep 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronan Berg, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318844
- Sponsor's protocol ID
- H-25024676
- Status last verified
- Jan 2026
- First submitted
- 31 Aug 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Volume at Rest and During Exercise in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07318844
- Acronym / sponsor ID
- H-25024676
- Conditions
- Healthy
- Keywords
- stroke volume, test-retest, Acute exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise bout | Experimental | Other: Cardiopulmonary exercise testA cardiopulmonary exercise test (CPET), during which stroke volume and heart rate are continuously measured |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women
- 18-70 years
Key exclusion criteria (9 listed)
- Known chronic lung disease
- Known ischaemic heart disease
- Known heart failure
- Symptoms of disease within 2 weeks prior to the study
- Known malignant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary exercise testThe 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). | Other | Exercise bout |
Primary outcome
Between-day smallest real difference (SRD) for stroke volume during upright rest
Time frame: 2-10 days
Between-day coefficient of variance (CV) for for stroke volume during upright rest
Time frame: 2-10 days
4 secondary outcomes
Between-day smallest real difference (SRD) for stroke volume during supine rest
Time frame: 2-10 days
Between-day coefficient of variance (CV) for stroke volume during supine rest
Time frame: 2-10 days
Between-day SRD for stroke volume at 60% of maximal workload (Wmax) during CPET
Time frame: 2-10 days
Between-day CV for stroke volume at 60% of Wmax during CPET
Time frame: 2-10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiopulmonary exercise test in people with Healthy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-day smallest real difference (SRD) for stroke volume during upright rest (time frame: 2-10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.