Overview

This trial is active, not recruiting.

Condition ageing
Treatments exercise intervention
Sponsor Norwegian University of Science and Technology
Start date August 2012
End date June 2018
Trial size 4000 participants
Trial identifier NCT01666340, Generation-100

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
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
exercise intervention Moderate training
Group asked to perform exercise at a given moderate intensity for a set time
exercise intervention High intensity
High intensity exercise
(Other)
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
exercise intervention Moderate training
Group asked to perform exercise at a given moderate intensity for a set time
exercise intervention High intensity
High intensity exercise

Primary Outcomes

Measure
Mortality
time frame: 5 years follow up

Secondary Outcomes

Measure
General measurements
time frame: 1 year follow up, 3 years follow up, 5 years follow up
Epigenetics
time frame: 1 year follow up, 3 years follow up, 5 years follow up
Morbidity
time frame: 3 and 5 years

Eligibility Criteria

Male or female participants from 70 years up to 76 years old.

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

Additional Information

Official title Generation 100: How Exercise Affects Mortality and Morbidity in the Elderly: A Randomized Control Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Norwegian University of Science and Technology.