Generation 100: How Exercise Affects Mortality and Morbidity in the Elderly: A Randomized Control Study (GEN100)
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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 |
- Maximal oxygen uptake [ Time Frame: 1 year ] [ Designated as safety issue: No ]maximal oxygen uptake, resting heart rate, recovery heart rate 1 minute after testing, blood sample post VO2max test, BP during before and after VO2max test
- 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
- Cognitive screening [ Time Frame: 1 year ] [ Designated as safety issue: No ]MMS
| Estimated Enrollment: | 4000 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2015 |
| Estimated 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 |
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| Contact: Ulrik Wisløff, Professor | 004772828113 | ulrik.wisloff@ntnu.no |
| Contact: Dorthe Stensvold, PhD | 004792092856 | dorthe.stensvold@ntnu.no |
| Norway | |
| Norwegian University of Science and Technology | Recruiting |
| Trondheim, Norway, 7006 | |
| Contact: Ulrik Wisløff, Professor 00477288113 ulrik.wisloff@ntnu.no | |
| Contact: Dorthe Stensvold, PhD 004792092856 dorthe.stensvold@ntun.no | |
| Sub-Investigator: Dorthe Stensvold, PhD | |
| Principal Investigator: Ulrik Wisløff, Professor | |
| 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: | August 10, 2012 |
| 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 June 17, 2013