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

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

Detailed Description
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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.

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

Conditions
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Ageing

Intervention / Treatment
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* Other: Exercise intervention
* Other: Exercise intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high intensity aerobic training<br>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<br>* Group asked to perform exercise at a given moderate intensity for a set time<br>* Other names: Moderate training;Other: Exercise intervention<br>* High intensity exercise<br>* Other names: High intensity;|
| Other: Moderate intensity training<br>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<br>* Group asked to perform exercise at a given moderate intensity for a set time<br>* Other names: Moderate training;Other: Exercise intervention<br>* High intensity exercise<br>* Other names: High intensity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | using data from governmental registers | 5 years follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General measurements | 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 | 1 year follow up, 3 years follow up, 5 years follow up | 
| Epigenetics | transcriptomics (messenger RNAs and microRNAs) and proteomics arrays, aimed at blood-borne factors induced by training. | 1 year follow up, 3 years follow up, 5 years follow up | 
| Morbidity | 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. | 3 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Elderly, Mortality, Morbidity, Prognosis, Longevity