Cardiovascular Risk Factors, Maximal Oxygen Uptake and Sedentariness: an Observational Study

September 18, 2017 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

874

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • Norwegian University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 77 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

elderly, norwegian

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Norwegian Elderly Population

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HDL blood correlation to maximal oxygen uptake
Time Frame: baseline
Maximal oxygen uptake test on the bike or treadmill
baseline
LDL blood correlation to maximal oxygen uptake
Time Frame: baseline
baseline
C-reactive protein (CRP) correlation to maximal oxygen uptake
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
sedentariness correlation with maximal oxygen uptake
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2012

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

July 19, 2013

First Submitted That Met QC Criteria

August 26, 2013

First Posted (ESTIMATE)

August 29, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 19, 2017

Last Update Submitted That Met QC Criteria

September 18, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Gen100sub3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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