NCT07318844

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

August 31, 2025

Last Update Submit

January 5, 2026

Conditions

Keywords

stroke volumetest-retestAcute exercise

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

EXPERIMENTAL

A cardiopulmonary exercise test (CPET), during which stroke volume and heart rate are continuously measured

Other: Cardiopulmonary exercise test

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).

Exercise bout

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

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

Locations