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

Norwegian University of Science and Technology

Status: Active, not recruiting

Conditions: Ageing

Treatments: Other: Exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01666340

Generation-100

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,567 patients

Sex: All

Ages: 70 to 76 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,567 participants in 2 patient groups

high intensity aerobic training

Experimental group

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

Treatment:

Other: Exercise intervention

Other: Exercise intervention

Moderate intensity training

Other group

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

Treatment:

Other: Exercise intervention

Other: Exercise intervention