AgingNCT01931111
Cardiovascular Risk Factors, Maximal Oxygen Uptake and Sedentariness: an Observational Study
An observational study of Aging, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
This is a substudy of the Generation-100 study (NCT01666340). The aim of this study is to find critical values for (1) maximal oxygen uptake and (2) sedentary behavior, below which cardiovascular risk parameter clustering is apparent in an elderly Norwegian population. Read more about this study
- Who is it for?
- Ages 70 to 77 years
- Conditions the study is for
- Aging
- How many people
- 874 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2012to Sep 2014
- 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 70 to 77 years
- All sexes
- No healthy volunteers
- Older adult
Study population: elderly, norwegian
Who may be able to join
- ability to walk at least 1km,
- born in 1938,1939,1940,1941 or 1942
- Sufficiently good health to be able to take part in the study, as determined by the researchers
Who cannot join
- Illness or disability that precludes exercise or hinders completion of the study
- Uncontrolled hypertension
- Symptomatic valve disease, hyper tropic cardio-myopathy or unstable angina
- Active cancer
- Test results indicating that study participation is unsafe
- Inclusion in other studies conflicting with participation in this one
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Cardiovascular Risk Factors, Sedentary Behaviors and Maximal Oxygen Uptake in an Elderly Norwegian Population
This is a substudy of the Generation-100 study (NCT01666340). The aim of this study is to find critical values for (1) maximal oxygen uptake and (2) sedentary behavior, below which cardiovascular risk parameter clustering is apparent in an elderly Norwegian population.
- Conditions
- Aging
- Keywords
- physical activity, maximal oxygen uptake
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Norwegian Elderly Population | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL blood correlation to maximal oxygen uptake
Maximal oxygen uptake test on the bike or treadmill
Measured: baseline
LDL blood correlation to maximal oxygen uptake
Measured: baseline
C-reactive protein (CRP) correlation to maximal oxygen uptake
Measured: baseline
Secondary outcomes (1)
sedentariness correlation with maximal oxygen uptake
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startAug 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 874 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- dorthe stensvold, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931111
- Sponsor's protocol ID
- Gen100sub3
- Status last verified
- Sep 2017
- First submitted
- 19 Jul 2013
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zisko N, Nauman J, Sandbakk SB, Aspvik NP, Salvesen O, Carlsen T, Viken H, Ingebrigtsen JE, Wisloff U, Stensvold D. Absolute and relative accelerometer thresholds for determining the association between physical activity and metabolic syndrome in the older adults: The Generation-100 study. BMC Geriatr. 2017 May 16;17(1):109. doi: 10.1186/s12877-017-0497-1.
PubMed 28511695
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Cardiovascular Risk Factors, Sedentary Behaviors and Maximal Oxygen Uptake in an Elderly Norwegian Population
- ClinicalTrials.gov ID
- NCT01931111
- Acronym / sponsor ID
- Gen100sub3
- Conditions
- Aging
- Keywords
- physical activity, maximal oxygen uptake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 874 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 29 Aug 2013 (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.
This is a substudy of the Generation-100 study (NCT01666340). The aim of this study is to find critical values for (1) maximal oxygen uptake and (2) sedentary behavior, below which cardiovascular risk parameter clustering is apparent in an elderly Norwegian population.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Norwegian Elderly Population | – | – |
Who may qualify
- Ages
- 70 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- elderly, norwegian
Key inclusion criteria (3 listed)
- ability to walk at least 1km,
- born in 1938,1939,1940,1941 or 1942
- Sufficiently good health to be able to take part in the study, as determined by the researchers
Key exclusion criteria (6 listed)
- Illness or disability that precludes exercise or hinders completion of the study
- Uncontrolled hypertension
- Symptomatic valve disease, hyper tropic cardio-myopathy or unstable angina
- Active cancer
- Test results indicating that study participation is unsafe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HDL blood correlation to maximal oxygen uptake
Time frame: baseline
Maximal oxygen uptake test on the bike or treadmill
LDL blood correlation to maximal oxygen uptake
Time frame: baseline
C-reactive protein (CRP) correlation to maximal oxygen uptake
Time frame: baseline
1 secondary outcome
sedentariness correlation with maximal oxygen uptake
Time frame: 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 19 Sep 2017.
- Results publication: PubMed 28511695Zisko N, Nauman J, Sandbakk SB, Aspvik NP, Salvesen O, Carlsen T, Viken H, Ingebrigtsen JE, Wisloff U, Stensvold D. Absolute and relative accelerometer thresholds for determining the association between physical activity and metabolic syndrome in the older adults: The Generation-100 study. BMC Geriatr. 2017 May 16;17(1):109. doi: 10.1186/s12877-017-0497-1.
- Individual participant dataSharing planned: Undecided
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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.
dorthe stensvold, 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 Aging, 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 3 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 19 Sep 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?
HDL blood correlation to maximal oxygen uptake (time frame: baseline). The study lists 3 primary outcomes in all. 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 NCT01931111, which also lists 1 linked publication.
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 19 Sep 2017.