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OpenTrials
Completed

NCT Number: 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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trygfondens Center for Aktiv Sundhed

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiopulmonary exercise test

Other

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).

Primary outcomes

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

    Time frame: 2-10 days

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

    Time frame: 2-10 days

Secondary outcomes

  1. Between-day smallest real difference (SRD) for stroke volume during supine rest

    Time frame: 2-10 days

  2. Between-day coefficient of variance (CV) for stroke volume during supine rest

    Time frame: 2-10 days

  3. Between-day SRD for stroke volume at 60% of maximal workload (Wmax) during CPET

    Time frame: 2-10 days

  4. Between-day CV for stroke volume at 60% of Wmax during CPET

    Time frame: 2-10 days

Other outcomes

  1. Between-day SRD for stroke volume at 40% of Wmax during CPET

    Time frame: 2-10 days

  2. Between-day CV for stroke volume at 40% of Wmax during CPET

    Time frame: 2-10 days

  3. Between-day SRD for stroke volume at 80% of Wmax during CPET

    Time frame: 2-10 days

  4. Between-day CV for stroke volume at 80% of Wmax during CPET

    Time frame: 2-10 days

  5. Between-day SRD for stroke volume at Wmax during CPET

    Time frame: 2-10 days

  6. Between-day CV for stroke volume at Wmax during CPET

    Time frame: 2-10 days

  7. Between-day intraclass correlation coefficient (ICC) for stroke volume during upright rest

    Time frame: 2-10 days

  8. Between-day ICC for stroke volume during supine rest

    Time frame: 2-10 days

  9. Between-day ICC for stroke volume at 60% of Wmax during CPET

    Time frame: 2-10 days

  10. Between-day ICC for stroke volume at 40% of Wmax during CPET

    Time frame: 2-10 days

  11. Between-day ICC for stroke volume at 80% of Wmax during CPET

    Time frame: 2-10 days

  12. Between-day ICC for stroke volume at Wmax during CPET

    Time frame: 2-10 days

  13. Between-day SRD for cardiac output (measured as the product of stroke volume and heart rate) during upright rest

    Time frame: 2-10 days

  14. Between-day CV for for cardiac output during upright rest

    Time frame: 2-10 days

  15. Between-day ICC for for cardiac output during upright rest

    Time frame: 2-10 days

  16. Between-day SRD for cardiac output during supine rest

    Time frame: 2-10 days

  17. Between-day CV for for cardiac output during supine rest

    Time frame: 2-10 days

  18. Between-day ICC for for cardiac output during supine rest

    Time frame: 2-10 days

  19. Between-day SRD for cardiac output at 60% of Wmax during CPET

    Time frame: 2-10 days

  20. Between-day CV for cardiac output at 60% of Wmax during CPET

    Time frame: 2-10 days

  21. Between-day ICC for cardiac output at 60% of Wmax during CPET

    Time frame: 2-10 days

  22. Between-day SRD for cardiac output at 40% of Wmax during CPET

    Time frame: 2-10 days

  23. Between-day CV for cardiac output at 40% of Wmax during CPET

    Time frame: 2-10 days

  24. Between-day ICC for cardiac output at 40% of Wmax during CPET

    Time frame: 2-10 days

  25. Between-day SRD for cardiac output at 80% of Wmax during CPET

    Time frame: 2-10 days

  26. Between-day CV for cardiac output at 80% of Wmax during CPET

    Time frame: 2-10 days

  27. Between-day ICC for cardiac output at 80% of Wmax during CPET

    Time frame: 2-10 days

  28. Between-day SRD for cardiac output at Wmax during CPET

    Time frame: 2-10 days

  29. Between-day CV for cardiac output at Wmax during CPET

    Time frame: 2-10 days

  30. Between-day ICC for cardiac output at Wmax during CPET

    Time frame: 2-10 days

  31. Between-day SRD for heart rate (measured with the CPET equipment) during upright rest

    Time frame: 2-10 days

  32. Between-day CV for for heart rate during upright rest

    Time frame: 2-10 days

  33. Between-day ICC for for heart rate during upright rest

    Time frame: 2-10 days

  34. Between-day SRD for heart rate during supine rest

    Time frame: 2-10 days

  35. Between-day CV for for heart rate during supine rest

    Time frame: 2-10 days

  36. Between-day ICC for for heart rate during supine rest

    Time frame: 2-10 days

  37. Between-day SRD for heart rate at 60% of Wmax during CPET

    Time frame: 2-10 days

  38. Between-day CV for heart rate at 60% of Wmax during CPET

    Time frame: 2-10 days

  39. Between-day ICC for heart rate at 60% of Wmax during CPET

    Time frame: 2-10 days

  40. Between-day SRD for heart rate at 40% of Wmax during CPET

    Time frame: 2-10 days

  41. Between-day CV for heart rate at 40% of Wmax during CPET

    Time frame: 2-10 days

  42. Between-day ICC for heart rate at 40% of Wmax during CPET

    Time frame: 2-10 days

  43. Between-day SRD for heart rate at 80% of Wmax during CPET

    Time frame: 2-10 days

  44. Between-day CV for heart rate at 80% of Wmax during CPET

    Time frame: 2-10 days

  45. Between-day ICC for heart rate at 80% of Wmax during CPET

    Time frame: 2-10 days

  46. Between-day SRD for heart rate at Wmax during CPET

    Time frame: 2-10 days

  47. Between-day CV for heart rate at Wmax during CPET

    Time frame: 2-10 days

  48. Between-day ICC for heart rate at Wmax during CPET

    Time frame: 2-10 days

  49. Uright-to supine changes in stroke volume, heart-rate and cardiac output and arterial blood pressure at rest

    Time frame: 2-10 days

  50. Changes in stroke volume from upright rest to exercise at 40%, 60%, 80% and 100% of Wmax.

    Time frame: 2-10 days

  51. Changes in cardiac output from upright rest to exercise at 40%, 60%, 80% and 100% of Wmax.

    Time frame: 2-10 days

  52. Changes in arterial blood pressure from upright rest to exercise at 40%, 60%, 80% and 100% of Wmax.

    Time frame: 2-10 days

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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