NCT01931111

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
874

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

2.1 years

First QC Date

July 19, 2013

Last Update Submit

September 18, 2017

Conditions

Aging

Keywords

physical activitymaximal oxygen uptake

Outcome Measures

Primary Outcomes (3)

  • HDL blood correlation to maximal oxygen uptake

    Maximal oxygen uptake test on the bike or treadmill

    baseline

  • LDL blood correlation to maximal oxygen uptake

    baseline

  • C-reactive protein (CRP) correlation to maximal oxygen uptake

    baseline

Secondary Outcomes (1)

  • sedentariness correlation with maximal oxygen uptake

    baseline

Study Arms (1)

Norwegian Elderly Population

Eligibility Criteria

Age70 Years - 77 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

elderly, norwegian

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, Norway

Location

Related Publications (1)

  • 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.

    PMID: 28511695RESULT

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • dorthe stensvold, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2013

First Posted

August 29, 2013

Study Start

August 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 19, 2017

Record last verified: 2017-09

Locations

NO(1)