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

Ageing Clinical Trial

— GEN100  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01666340
• Other study ID #: Generation-100
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 21, 2012
• Est. completion date: June 2023

Study information

• Verified date: November 2022
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1567
• Est. completion date: June 2023
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Ageing

Intervention

Other:
• Exercise intervention
Group asked to perform exercise at a given moderate intensity for a set time
• Exercise intervention
High intensity exercise

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (4)

Letnes JM, Berglund I, Johnson KE, Dalen H, Nes BM, Lydersen S, Viken H, Hassel E, Steinshamn S, Vesterbekkmo EK, Støylen A, Reitlo LS, Zisko N, Bækkerud FH, Tari AR, Ingebrigtsen JE, Sandbakk SB, Carlsen T, Anderssen SA, Singh MAF, Coombes JS, Helbostad — View Citation

Stensvold D, Viken H, Rognmo Ø, Skogvoll E, Steinshamn S, Vatten LJ, Coombes JS, Anderssen SA, Magnussen J, Ingebrigtsen JE, Fiatarone Singh MA, Langhammer A, Støylen A, Helbostad JL, Wisløff U. A randomised controlled study of the long-term effects of exercise training on mortality in elderly people: study protocol for the Generation 100 study. BMJ Open. 2015 Feb 12;5(2):e007519. doi: 10.1136/bmjopen-2014-007519. — View Citation

Stensvold D, Viken H, Steinshamn SL, Dalen H, Støylen A, Loennechen JP, Reitlo LS, Zisko N, Bækkerud FH, Tari AR, Sandbakk SB, Carlsen T, Ingebrigtsen JE, Lydersen S, Mattsson E, Anderssen SA, Fiatarone Singh MA, Coombes JS, Skogvoll E, Vatten LJ, Helbost — View Citation

Viken H, Reitlo LS, Zisko N, Nauman J, Aspvik NP, Ingebrigtsen JE, Wisløff U, Stensvold D. Predictors of Dropout in Exercise Trials in Older Adults: The Generation 100 Study. Med Sci Sports Exerc. 2019 Jan;51(1):49-55. doi: 10.1249/MSS.0000000000001742. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive screening	Mini Mental Status (MMS)	1 year follow up, 3 years follow up, 5 years follow ut
Primary	Mortality	using data from governmental registers	5 years follow up
Secondary	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
Secondary	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
Secondary	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

External Links

•   Generation 100 web page
•   Results published in BMJ Oct 2020