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: March 23, 2014
Last verified: March 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 and Morbidity [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Follow up the participants and look at morbidity (i.e. cardiovascular disease, cancer, etc.) review mortality using governmental registers


Secondary Outcome Measures:
  • General measurements [ Time Frame: 1 year ] [ 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


Other Outcome Measures:
  • Cognitive screening [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Mini Mental Status (MMS)


Estimated Enrollment: 4000
Study Start Date: August 2012
Estimated Study Completion Date: August 2015
Primary Completion Date: August 2013 (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, and after three years. Additionally, participants will be followed by by linking to relevant registers for up to 20 years. 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 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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: March 23, 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 April 22, 2014