HealthyGEN100NCT02017847
Intensity of Physical Activity Measured by Activity Monitors in Elderly Persons
An observational study of Healthy, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Aim of this study is to identify intensity cut off points for physical activity in a population over the age of 70. Read more about this study
- Who is it for?
- Ages 70 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2013to Jan 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 76 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Persons in the age of 70-76 living in Trondheim, Norway
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
- 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.
Norway1 site
NTNU, Faculty of Medicine Department, of Circulation and Medical Imaging
Trondheim, 7491
About this study
Official title: Assessment of Intensity Cut Off Points for Physical Activity Measured by Activity Monitors in Elderly Persons
Aim of this study is to identify intensity cut off points for physical activity in a population over the age of 70.
Read the detailed description
Activity monitors measure activity in counts. The higher the counts, the higher the intensity of the measured activity. In this study the count cut off points for low, moderate and high intensity activity will be investigated in a population of elderly people over the age of 70. This information will subsequently (in future studies) be used to investigate the physical activity patterns in a population of elderly over the age of 70 who have worn an activity monitor for a duration of 7 days.
- Conditions
- Healthy
- Keywords
- oxygen consumption, activity monitors, METs, intensity
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 |
|---|---|---|
| Gen100 | 150 participants in the Generation 100 study with anticipated 3000 participants aged 70-75 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of physical activity
measured in counts by activity monitors
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2014
- Study completionJan 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 HealthyStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Zisko, MSc, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017847
- Sponsor's protocol ID
- GEN100Study5
- Acronym
- GEN100
- Status last verified
- Aug 2016
- First submitted
- 17 Dec 2013
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zisko N, Carlsen T, Salvesen O, Aspvik NP, Ingebrigtsen JE, Wisloff U, Stensvold D. New relative intensity ambulatory accelerometer thresholds for elderly men and women: the Generation 100 study. BMC Geriatr. 2015 Aug 4;15:97. doi: 10.1186/s12877-015-0093-1.
PubMed 26238198
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Intensity Cut Off Points for Physical Activity Measured by Activity Monitors in Elderly Persons
- ClinicalTrials.gov ID
- NCT02017847
- Acronym / sponsor ID
- GEN100 / GEN100Study5
- Conditions
- Healthy
- Keywords
- oxygen consumption, activity monitors, METs, intensity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 Dec 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.
Aim of this study is to identify intensity cut off points for physical activity in a population over the age of 70.
Detailed description
Activity monitors measure activity in counts. The higher the counts, the higher the intensity of the measured activity. In this study the count cut off points for low, moderate and high intensity activity will be investigated in a population of elderly people over the age of 70. This information will subsequently (in future studies) be used to investigate the physical activity patterns in a population of elderly over the age of 70 who have worn an activity monitor for a duration of 7 days.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gen100 | – | –150 participants in the Generation 100 study with anticipated 3000 participants aged 70-75 |
Who may qualify
- Ages
- 70 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Persons in the age of 70-76 living in Trondheim, Norway
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 (8 listed)
- Illness or disability that precludes exercise or hinders completion of the study
- Uncontrolled hypertension
- Symptomatic valve disease
- hyper tropic cardio-myopathy
- unstable angina
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
Intensity of physical activity
Time frame: 1 year
measured in counts by activity monitors
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 4 Aug 2016.
- Results publication: PubMed 26238198Zisko N, Carlsen T, Salvesen O, Aspvik NP, Ingebrigtsen JE, Wisloff U, Stensvold D. New relative intensity ambulatory accelerometer thresholds for elderly men and women: the Generation 100 study. BMC Geriatr. 2015 Aug 4;15:97. doi: 10.1186/s12877-015-0093-1.
- Generation 100Link provided by the sponsor.
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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.
Nina Zisko, MSc 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, 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 8 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 4 Aug 2016. 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?
Intensity of physical activity (time frame: 1 year). 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 NCT02017847, 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 4 Aug 2016.