SVproject: Cardiac Stroke Volume at Rest and During Different Exercise Intensities

• Sponsor: Turku University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04287114
• Collaborator: (none)
• Enrollment: 20
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 10.7
• Patients Per Site: 10
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Function	Behavioral: Acute exercise	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Cardiac Stroke Volume at Rest and During Different Exercise Intensities
• Actual Study Start Date: Feb 8, 2021
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy young men and women Single group consisting of 10 men and 10 women	Behavioral: Acute exercise; Acute exercise with different exercise intensities

Outcome Measures

Primary Outcome Measures

1. Cardiac stroke volume [1 min]

Secondary Outcome Measures

1. End-diastolic and end-systolic volumes [1 min]

2. Ejection fraction [1 min]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age 18-45

• BMI 18-30

• Resting Blood pressure < 140/90 mmHg

• Participation in regular exercise

Exclusion Criteria:

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Turku PET Centre	Turku		Finland	20521
2	University of Turku	Turku		Finland

Sponsors and Collaborators

• Turku University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Turku University Hospital
• ClinicalTrials.gov Identifier: NCT04287114
• Other Study ID Numbers: T24/2020
• First Posted: Feb 27, 2020
• Last Update Posted: Feb 9, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 9, 2021