<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01666340</url>
  </required_header>
  <id_info>
    <org_study_id>Generation-100</org_study_id>
    <nct_id>NCT01666340</nct_id>
  </id_info>
  <brief_title>Generation 100: How Exercise Affects Mortality and Morbidity in the Elderly: A Randomized Control Study</brief_title>
  <acronym>GEN100</acronym>
  <official_title>Generation 100: How Exercise Affects Mortality and Morbidity in the Elderly: A Randomized Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis: Exercise will reduce morbidity and mortality rates in an elderly population. The&#xD;
      extent of reduction will be intensity dependent.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Literature lacks large controlled randomized studies that look at the effect of exercise&#xD;
      training on morbidity and mortality. Generation 100 will be the first randomized, controlled&#xD;
      clinical study where the primary objective is to study the effects of exercise training on&#xD;
      morbidity and mortality in the elderly. Furthermore, the researchers will investigate whether&#xD;
      there is a relationship between the exercise intensity and health benefits, with particular&#xD;
      focus on major health problems in the elderly population. In addition to being a study, this&#xD;
      is also an initiative to improve public health in all healthy individuals between 70-75 years&#xD;
      of age in the Trondheim municipality. The participants will either be randomized to&#xD;
      supervised exercise or follow current guidelines for physical activity on their own. Clinical&#xD;
      examinations, as well as questionnaires, will be administered to all participants at&#xD;
      baseline, after one year, after three years, and after five years. Additionally, participants&#xD;
      will be followed-up by linking to relevant registers for up to 20 years.&#xD;
&#xD;
      Also data will be collected with the purposes of (a) investigating genetic predisposition for&#xD;
      fitness and cardiovascular diseases, and (b) identification of potential targets for&#xD;
      therapies.&#xD;
&#xD;
      The study seeks to determine if exercise training gives the seniors a longer active and&#xD;
      healthy life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 21, 2012</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>5 years follow up</time_frame>
    <description>using data from governmental registers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>General measurements</measure>
    <time_frame>1 year follow up, 3 years follow up, 5 years follow up</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epigenetics</measure>
    <time_frame>1 year follow up, 3 years follow up, 5 years follow up</time_frame>
    <description>transcriptomics (messenger RNAs and microRNAs) and proteomics arrays, aimed at blood-borne factors induced by training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>3 and 5 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cognitive screening</measure>
    <time_frame>1 year follow up, 3 years follow up, 5 years follow ut</time_frame>
    <description>Mini Mental Status (MMS)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1567</enrollment>
  <condition>Ageing</condition>
  <arm_group>
    <arm_group_label>high intensity aerobic training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate intensity training</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise intervention</intervention_name>
    <description>Group asked to perform exercise at a given moderate intensity for a set time</description>
    <arm_group_label>Moderate intensity training</arm_group_label>
    <arm_group_label>high intensity aerobic training</arm_group_label>
    <other_name>Moderate training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise intervention</intervention_name>
    <description>High intensity exercise</description>
    <arm_group_label>Moderate intensity training</arm_group_label>
    <arm_group_label>high intensity aerobic training</arm_group_label>
    <other_name>High intensity</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Born in 1936, 1937, 1938, 1939, 1940, 1941 or 1942&#xD;
&#xD;
          -  Able to complete the exercise program (determined by the researchers).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Illness or disabilities that preclude exercise or hinder completion of the study&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Symptomatic valvular, hypertrophic cardiomyopathy, unstable angina, pulmonary&#xD;
             hypertension, heart failure and severe arrhythmia&#xD;
&#xD;
          -  Diagnosed dementia&#xD;
&#xD;
          -  Cancer that makes participation impossible or exercise contraindicated. Considered&#xD;
             individually, in consultation with the attending physician.&#xD;
&#xD;
          -  Chronic communicable infectious diseases.&#xD;
&#xD;
          -  Test results indicating that study participation is unsafe&#xD;
&#xD;
          -  Participation in other studies conflicting with participation in Generation 100&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>76 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulrik Wisløff, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Norwegian University of Science and Technology</name>
      <address>
        <city>Trondheim</city>
        <zip>7006</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <link>
    <url>http://www.ntnu.edu/cerg/generation100</url>
    <description>Generation 100 web page</description>
  </link>
  <link>
    <url>https://doi.org/10.1136/bmj.m3485</url>
    <description>Results published in BMJ Oct 2020</description>
  </link>
  <reference>
    <citation>Stensvold D, Viken H, Rognmo O, Skogvoll E, Steinshamn S, Vatten LJ, Coombes JS, Anderssen SA, Magnussen J, Ingebrigtsen JE, Fiatarone Singh MA, Langhammer A, Stoylen A, Helbostad JL, Wisloff U. A randomised controlled study of the long-term effects of exercise training on mortality in elderly people: study protocol for the Generation 100 study. BMJ Open. 2015 Feb 12;5(2):e007519. doi: 10.1136/bmjopen-2014-007519.</citation>
    <PMID>25678546</PMID>
  </reference>
  <reference>
    <citation>Viken H, Reitlo LS, Zisko N, Nauman J, Aspvik NP, Ingebrigtsen JE, Wisloff U, Stensvold D. Predictors of Dropout in Exercise Trials in Older Adults: The Generation 100 Study. Med Sci Sports Exerc. 2019 Jan;51(1):49-55. doi: 10.1249/MSS.0000000000001742.</citation>
    <PMID>30113524</PMID>
  </reference>
  <results_reference>
    <citation>Stensvold D, Viken H, Steinshamn SL, Dalen H, Stoylen A, Loennechen JP, Reitlo LS, Zisko N, Baekkerud FH, Tari AR, Sandbakk SB, Carlsen T, Ingebrigtsen JE, Lydersen S, Mattsson E, Anderssen SA, Fiatarone Singh MA, Coombes JS, Skogvoll E, Vatten LJ, Helbostad JL, Rognmo O, Wisloff U. Effect of exercise training for five years on all cause mortality in older adults-the Generation 100 study: randomised controlled trial. BMJ. 2020 Oct 7;371:m3485. doi: 10.1136/bmj.m3485.</citation>
    <PMID>33028588</PMID>
  </results_reference>
  <results_reference>
    <citation>Letnes JM, Berglund I, Johnson KE, Dalen H, Nes BM, Lydersen S, Viken H, Hassel E, Steinshamn S, Vesterbekkmo EK, Stoylen A, Reitlo LS, Zisko N, Baekkerud FH, Tari AR, Ingebrigtsen JE, Sandbakk SB, Carlsen T, Anderssen SA, Singh MAF, Coombes JS, Helbostad JL, Rognmo O, Wisloff U, Stensvold D. Effect of 5 years of exercise training on the cardiovascular risk profile of older adults: the Generation 100 randomized trial. Eur Heart J. 2022 Jun 1;43(21):2065-2075. doi: 10.1093/eurheartj/ehab721.</citation>
    <PMID>34746955</PMID>
  </results_reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>November 22, 2022</last_update_submitted>
  <last_update_submitted_qc>November 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Elderly</keyword>
  <keyword>Mortality</keyword>
  <keyword>Morbidity</keyword>
  <keyword>Prognosis</keyword>
  <keyword>Longevity</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01666340
org study id: Generation-100
nct id: NCT01666340
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Hypothesis: Exercise will reduce morbidity and mortality rates in an elderly population. The
      extent of reduction will be intensity dependent.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Mortality
time frame: 5 years follow up
description: using data from governmental registers
measure: General measurements
time frame: 1 year follow up, 3 years follow up, 5 years follow up
description: 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
measure: Epigenetics
time frame: 1 year follow up, 3 years follow up, 5 years follow up
description: transcriptomics (messenger RNAs and microRNAs) and proteomics arrays, aimed at blood-borne factors induced by training.
measure: Morbidity
time frame: 3 and 5 years
description: 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.
measure: Cognitive screening
time frame: 1 year follow up, 3 years follow up, 5 years follow ut
description: Mini Mental Status (MMS)
arm group label: high intensity aerobic training
arm group type: Experimental
description: 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
arm group label: Moderate intensity training
arm group type: Other
description: 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
intervention type: Other
intervention name: Exercise intervention
description: Group asked to perform exercise at a given moderate intensity for a set time
arm group label: Moderate intensity training
arm group label: high intensity aerobic training
other name: Moderate training
intervention type: Other
intervention name: Exercise intervention
description: High intensity exercise
arm group label: Moderate intensity training
arm group label: high intensity aerobic training
other name: High intensity
criteria: 
gender: All
minimum age: 70 Years
maximum age: 76 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ulrik Wisløff, Professor
role: Study Chair
affiliation: Norwegian University of Science and Technology
facility: 
country: Norway
url: http://www.ntnu.edu/cerg/generation100
description: Generation 100 web page
url: https://doi.org/10.1136/bmj.m3485
description: Results published in BMJ Oct 2020
citation: Stensvold D, Viken H, Rognmo O, Skogvoll E, Steinshamn S, Vatten LJ, Coombes JS, Anderssen SA, Magnussen J, Ingebrigtsen JE, Fiatarone Singh MA, Langhammer A, Stoylen A, Helbostad JL, Wisloff U. A randomised controlled study of the long-term effects of exercise training on mortality in elderly people: study protocol for the Generation 100 study. BMJ Open. 2015 Feb 12;5(2):e007519. doi: 10.1136/bmjopen-2014-007519.
PMID: 25678546
citation: Viken H, Reitlo LS, Zisko N, Nauman J, Aspvik NP, Ingebrigtsen JE, Wisloff U, Stensvold D. Predictors of Dropout in Exercise Trials in Older Adults: The Generation 100 Study. Med Sci Sports Exerc. 2019 Jan;51(1):49-55. doi: 10.1249/MSS.0000000000001742.
PMID: 30113524
citation: Stensvold D, Viken H, Steinshamn SL, Dalen H, Stoylen A, Loennechen JP, Reitlo LS, Zisko N, Baekkerud FH, Tari AR, Sandbakk SB, Carlsen T, Ingebrigtsen JE, Lydersen S, Mattsson E, Anderssen SA, Fiatarone Singh MA, Coombes JS, Skogvoll E, Vatten LJ, Helbostad JL, Rognmo O, Wisloff U. Effect of exercise training for five years on all cause mortality in older adults-the Generation 100 study: randomised controlled trial. BMJ. 2020 Oct 7;371:m3485. doi: 10.1136/bmj.m3485.
PMID: 33028588
citation: Letnes JM, Berglund I, Johnson KE, Dalen H, Nes BM, Lydersen S, Viken H, Hassel E, Steinshamn S, Vesterbekkmo EK, Stoylen A, Reitlo LS, Zisko N, Baekkerud FH, Tari AR, Ingebrigtsen JE, Sandbakk SB, Carlsen T, Anderssen SA, Singh MAF, Coombes JS, Helbostad JL, Rognmo O, Wisloff U, Stensvold D. Effect of 5 years of exercise training on the cardiovascular risk profile of older adults: the Generation 100 randomized trial. Eur Heart J. 2022 Jun 1;43(21):2065-2075. doi: 10.1093/eurheartj/ehab721.
PMID: 34746955
responsible party type: Sponsor