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NCT Number: NCT01666340

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

Hypothesis: Exercise will reduce morbidity and mortality rates in an elderly population. The extent of reduction will be intensity dependent.

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This study is active but is not currently recruiting participants.

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Key information

Age range

70 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian University of Science and Technology

Trondheim, 7006, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise intervention

Other

Group asked to perform exercise at a given moderate intensity for a set time

Other names: Moderate training

Primary outcomes

  1. Mortality

    Time frame: 5 years follow up

    using data from governmental registers

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. Mortality and Morbidity

    Time frame: 10 years

    Look at morbidity after 10 year follow-up

Other outcomes

  1. Cognitive screening

    Time frame: 1 year follow up, 3 years follow up, 5 years follow ut

    Mini Mental Status (MMS)

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Acronym: GEN100

Important dates

Study start
2012
Primary completion
2018
Study completion
2026
First posted
Aug 16, 2012
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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