NCT04287114

Brief Summary

The main aim of the present investigation is to study cardiac function in different exercise intensities in healthy human subjects. Two techniques will be used: cardiac ultrasound-derived stroke volume measurements and body impedance measurements. 20 healthy men (n=10) and women (n=10) aged 18-45 years will be investigated at rest and during exercise. All study procedures are non-invasive.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

2 active sites

Status
unknown

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

February 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

February 8, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

February 25, 2020

Last Update Submit

February 8, 2021

Conditions

Cardiac Function

Outcome Measures

Primary Outcomes (1)

  • Cardiac stroke volume

    1 min

Secondary Outcomes (2)

  • End-diastolic and end-systolic volumes

    1 min

  • Ejection fraction

    1 min

Study Arms (1)

Healthy young men and women

EXPERIMENTAL

Single group consisting of 10 men and 10 women

Behavioral: Acute exercise

Interventions

Acute exerciseBEHAVIORAL

Acute exercise with different exercise intensities

Healthy young men and women

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-45
  • BMI 18-30
  • Resting Blood pressure \< 140/90 mmHg
  • Participation in regular exercise

You may not qualify if:

  • Acute illness
  • Pregnancy
  • Pace maker
  • Artificial joint
  • History of a cardiac event
  • Insulin or medically treated diabetes
  • Any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
  • Abundant use of alcohol
  • Use of narcotics
  • Smoking of tobacco or consuming snuff tobacco
  • Diagnosed depressive or bipolar disorder
  • Abnormalities in resting ECG (revised by the study physician)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Turku PET Centre

Turku, 20521, Finland

RECRUITING

University of Turku

Turku, Finland

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Ilkka HA Heinonen, PhD

CONTACT

408393962ilkka.heinonen@utu.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 27, 2020

Study Start

February 8, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

FI(2)