Cardiovascular Fitness and Venous Function in Trained and... | NCT01215630

Studies
Cardiovascular Fitness and Venous Function in Trained and Untrained Subjects

NCT01215630

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Feb 9, 2017Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Healthy Subjects

Interventions

Aerobic Interval Training

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010Actual

Primary Completion Date

Mar 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Oct 4, 2010

First Submission Date that Met QC Criteria

Oct 5, 2010

First Posted Date

Oct 6, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2017

Last Update Posted Date

Feb 9, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary aim is to study the relationship between vascular function, cardiovascular fitness and age in healthy subjects. Individuals with the highest cardiovascular fitness will have the greatest arterial inflow independent of age.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy subjects		Men Women Age; 18-75	Behavioral: Aerobic Interval Training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aerobic Interval Training	Behavioral	One interval training session	Healthy subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Venous Compliance	Echocardiography; Test - retest	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Maximal oxygen uptake	Cardiopulmonary testing	one test at baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy subjects, 18-75 years of age

Exclusion Criteria:

Inability to exercise due to musculoskeletal conditions
Known ischemic cardiovascular disease
Smoking or tobacco use
Acute medical conditions
Active infections
Pharmacotherapy with known vascular effects

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy men and women, aged 18-75 yrs

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Trine Karlsen, PhD	Norwegian University of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Norwegian University of Science and Technology		Trondheim		7491	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26667796	Result	Leinan IM, Aamot IL, Stoylen A, Karlsen T, Wisloff U. Upper arm venous compliance and fitness in stable coronary artery disease patients and healthy controls. Clin Physiol Funct Imaging. 2017 Sep;37(5):498-506. doi: 10.1111/cpf.12324. Epub 2015 Dec 15.
	Result	Leinan IM, Grønnevik Ø, Støylen A, Wisløff U, Karlsen T. A cross sectional study of arm venous compliance in fit healthy subjects. Journal of Cardiovascular Research 1(2). http://www.vipoa.org/journals/pdf/5947267721.pdf