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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01666340
First received: August 8, 2012
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention
Ageing
Other: Exercise intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Generation 100: How Exercise Affects Mortality and Morbidity in the Elderly: A Randomized Control Study

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Mortality [ Time Frame: 5 years follow up ] [ Designated as safety issue: No ]
    using data from governmental registers


Secondary Outcome Measures:
  • General measurements [ Time Frame: 1 year follow up, 3 years follow up, 5 years follow up ] [ Designated as safety issue: No ]
    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

  • Epigenetics [ Time Frame: 1 year follow up, 3 years follow up, 5 years follow up ] [ Designated as safety issue: No ]
    transcriptomics (messenger RNAs and microRNAs) and proteomics arrays, aimed at blood-borne factors induced by training.

  • Morbidity [ Time Frame: 3 and 5 years ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Cognitive screening [ Time Frame: 1 year follow up, 3 years follow up, 5 years follow ut ] [ Designated as safety issue: No ]
    Mini Mental Status (MMS)


Estimated Enrollment: 4000
Study Start Date: August 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Moderate training
Other: Exercise intervention
High intensity exercise
Other Name: High intensity
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 Name: Moderate training
Other: Exercise intervention
High intensity exercise
Other Name: High intensity

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.

  Eligibility

Ages Eligible for Study:   70 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666340

Locations
Norway
Norwegian University of Science and Technology
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Study Chair: Ulrik Wisløff, Professor Norwegian University of Science and Technology
  More Information

Additional Information:
No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01666340     History of Changes
Other Study ID Numbers: Generation-100
Study First Received: August 8, 2012
Last Updated: September 9, 2014
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Norwegian University of Science and Technology:
Exercise
Elderly
Mortality
Morbidity
Prognosis
Longevity

ClinicalTrials.gov processed this record on September 16, 2014