Generation 100: How Exercise Affects Mortality and Morbidity in the Elderly: A Randomized Control Study (GEN100)

November 22, 2022 updated by: Norwegian University of Science and Technology
Hypothesis: Exercise will reduce morbidity and mortality rates in an elderly population. The extent of reduction will be intensity dependent.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Literature lacks large controlled randomized studies that look at the effect of exercise training on morbidity and mortality. Generation 100 will be the first randomized, controlled clinical study where the primary objective is to study the effects of exercise training on morbidity and mortality in the elderly. Furthermore, the researchers will investigate whether there is a relationship between the exercise intensity and health benefits, with particular focus on major health problems in the elderly population. In addition to being a study, this is also an initiative to improve public health in all healthy individuals between 70-75 years of age in the Trondheim municipality. The participants will either be randomized to supervised exercise or follow current guidelines for physical activity on their own. Clinical examinations, as well as questionnaires, will be administered to all participants at baseline, after one year, after three years, and after five years. Additionally, participants will be followed-up by linking to relevant registers for up to 20 years.

Also data will be collected with the purposes of (a) investigating genetic predisposition for fitness and cardiovascular diseases, and (b) identification of potential targets for therapies.

The study seeks to determine if exercise training gives the seniors a longer active and healthy life.

Study Type

Interventional

Enrollment (Actual)

1567

Phase

  • Not Applicable

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, 7006
        • 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 76 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Born in 1936, 1937, 1938, 1939, 1940, 1941 or 1942
  • Able to complete the exercise program (determined by the researchers).

Exclusion Criteria:

  • Illness or disabilities that preclude exercise or hinder completion of the study
  • Uncontrolled hypertension
  • Symptomatic valvular, hypertrophic cardiomyopathy, unstable angina, pulmonary hypertension, heart failure and severe arrhythmia
  • Diagnosed dementia
  • Cancer that makes participation impossible or exercise contraindicated. Considered individually, in consultation with the attending physician.
  • Chronic communicable infectious diseases.
  • Test results indicating that study participation is unsafe
  • Participation in other studies conflicting with participation in Generation 100

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high intensity aerobic training
Exercise intervention: High intensity group performing high intensity training where they are required to raise their heart rate several times during the workout and reach perceived exhaustion of 16 on a Borg scale
Other: Exercise intervention
Group asked to perform exercise at a given moderate intensity for a set time
Other Names:
  • Moderate training
Other: Exercise intervention
High intensity exercise
Other Names:
  • High intensity
Other: Moderate intensity training
Exercise intervention: Moderate intensity Group of people asked to perform moderate training where they exercise at a given intensity (moderate as per Borg scale) for a certain amount of time
Other: Exercise intervention
Group asked to perform exercise at a given moderate intensity for a set time
Other Names:
  • Moderate training
Other: Exercise intervention
High intensity exercise
Other Names:
  • High intensity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 5 years follow up
using data from governmental registers
5 years follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General measurements
Time Frame: 1 year follow up, 3 years follow up, 5 years follow up
resting blood pressure, resting fasting blood sample, resting heart rate, weight, height and waistline, body composition (muscle vs fat) questionnaires (activity, safety, monthly training diary) walking test, grip strength test, leg strength test, pulmonary function, physical activity level
1 year follow up, 3 years follow up, 5 years follow up
Epigenetics
Time Frame: 1 year follow up, 3 years follow up, 5 years follow up
transcriptomics (messenger RNAs and microRNAs) and proteomics arrays, aimed at blood-borne factors induced by training.
1 year follow up, 3 years follow up, 5 years follow up
Morbidity
Time Frame: 3 and 5 years
Look at morbidity after 3 and 5 years follow up(i.e. cardiovascular disease, cancer, etc.) using medical records and link to the different health registers.
3 and 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive screening
Time Frame: 1 year follow up, 3 years follow up, 5 years follow ut
Mini Mental Status (MMS)
1 year follow up, 3 years follow up, 5 years follow ut

Collaborators and Investigators

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

Sponsor

Norwegian University of Science and Technology

Investigators

  • Study Chair: Ulrik Wisløff, Professor, 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

Helpful Links

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 21, 2012

Primary Completion (Actual)

June 1, 2018

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

August 10, 2012

First Posted (Estimate)

August 16, 2012

Study Record Updates

Last Update Posted (Actual)

November 23, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Generation-100

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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