Healthy SubjectsNCT01215630
Cardiovascular Fitness and Venous Function in Trained and Untrained Subjects
An observational study of Healthy Subjects, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Aerobic Interval Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2010to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy men and women, aged 18-75 yrs
Who may be able to join
- Healthy subjects, 18-75 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy Subjects
- Being tested
- Aerobic Interval Training
- Keywords
- Veins, Exercise tests, maximal oxygen uptake, VO2max
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Interval TrainingBehavioural
One interval training session
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Men Women Age; 18-75 Receives: Behavioral: Aerobic Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous Compliance
Echocardiography; Test - retest
Measured: 2 weeks
Secondary outcomes (1)
Maximal oxygen uptake
Cardiopulmonary testing
Measured: one test at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trine Karlsen, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215630
- Sponsor's protocol ID
- REK 2010/1512-2
- Status last verified
- Feb 2017
- First submitted
- 4 Oct 2010
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26667796Leinan 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Fitness and Venous Function in Trained and Untrained Subjects
- ClinicalTrials.gov ID
- NCT01215630
- Acronym / sponsor ID
- REK 2010/1512-2
- Conditions
- Healthy Subjects
- Keywords
- Veins, Exercise tests, maximal oxygen uptake, VO2max
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Oct 2010 (actual)
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 6 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Behavioral: Aerobic Interval TrainingMen Women Age; 18-75 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy men and women, aged 18-75 yrs
Key inclusion criteria (1 listed)
- Healthy subjects, 18-75 years of age
Key exclusion criteria (6 listed)
- Inability to exercise due to musculoskeletal conditions
- Known ischemic cardiovascular disease
- Smoking or tobacco use
- Acute medical conditions
- Active infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Interval TrainingOne interval training session | Behavioural | Healthy subjects |
Primary outcome
Venous Compliance
Time frame: 2 weeks
Echocardiography; Test - retest
1 secondary outcome
Maximal oxygen uptake
Time frame: one test at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Results publication: PubMed 26667796Leinan 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.
- Results publicationLeinan 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trine Karlsen, PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Subjects, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous Compliance (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01215630, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.