AgingGen100sub2NCT01915290
Physical Activity and Its Correlation to Maximal Oxygen Uptake in an Elderly Population
An observational study of Aging, run by Norwegian University of Science and Technology.
Trial summary
This is a substudy of the Generation-100 study (NCT01666340). Self reported physical activity versus objectively measured physical activity and its correlation to maximal oxygen uptake in an elderly Norwegian population (observational study). Read more about this study
- Who is it for?
- Ages 70 to 77 years
- Conditions the study is for
- Aging
- How many people
- 1,237 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Jul 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: Norwegian elderly population 70-77 years of age
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
About this study
Official title: Self Reported Physical Activity vs Objectively Measured Physical Activity and Its Correlation to Maximal Oxygen Uptake in an Elderly Population: an Observational Study
This is a substudy of the Generation-100 study (NCT01666340). Self reported physical activity versus objectively measured physical activity and its correlation to maximal oxygen uptake in an elderly Norwegian population (observational study).
Read the detailed description
Data is collected using activity monitors. This data then compared to self reported physical activity obtained through questionnaires. Questionnaires are based on recall. Overall physical activity will then be correlated to maximal oxygen uptake to see whether people with high activity also have high maximal oxygen uptake.
- 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 |
|---|---|---|
| 1600 elderly participants | Norwegian elderly population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between maximal oxygen uptake and activity level
maximal oxygen uptake measured using Metamax on a Treadmill. Activity level assessed using triaxial activity monitors.
Measured: baseline
Secondary outcomes (1)
Difference between self reported recall physical activity and activity monitor measured physical activity
self reported Physical Activity is assessed by having participants fill out a questionnaire (developed by HUNT) outlining their Physical Activity (through recall).
Physical activity is objectively measured using triaxial accelerometers.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startAug 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 1,237 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 TechnologyUlrik Wisløff, PhD, Study chair, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915290
- Sponsor's protocol ID
- Gen100sub2
- Acronym
- Gen100sub2
- Status last verified
- Aug 2014
- First submitted
- 22 Jul 2013
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Reported Physical Activity vs Objectively Measured Physical Activity and Its Correlation to Maximal Oxygen Uptake in an Elderly Population: an Observational Study
- ClinicalTrials.gov ID
- NCT01915290
- Acronym / sponsor ID
- Gen100sub2 / Gen100sub2
- Conditions
- Aging
- Keywords
- physical activity, maximal oxygen uptake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,237 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 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). Self reported physical activity versus objectively measured physical activity and its correlation to maximal oxygen uptake in an elderly Norwegian population (observational study).
Detailed description
Data is collected using activity monitors. This data then compared to self reported physical activity obtained through questionnaires. Questionnaires are based on recall. Overall physical activity will then be correlated to maximal oxygen uptake to see whether people with high activity also have high maximal oxygen uptake.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1600 elderly participants | – | –Norwegian elderly population |
Who may qualify
- Ages
- 70 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Norwegian elderly population 70-77 years of age
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
Correlation between maximal oxygen uptake and activity level
Time frame: baseline
maximal oxygen uptake measured using Metamax on a Treadmill. Activity level assessed using triaxial activity monitors.
1 secondary outcome
Difference between self reported recall physical activity and activity monitor measured physical activity
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 13 Aug 2014.
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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
Ulrik Wisløff, PhD study chair
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by Norwegian University of Science and Technology.
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 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Correlation between maximal oxygen uptake and activity level (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2014.