Clinical trial NCT01666340: Generation 100: How Exercise Affects Mortality and Morbidity in the Elderly: A Randomized Control Study
Official title: Generation 100: How Exercise Affects Mortality and Morbidity in the Elderly: A Randomized Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ageing
Keywords: Exercise
Elderly
Mortality
Morbidity
Prognosis
Longevity
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2012-08-16
Enrollment: 1567
Sex: ALL
Minimum age (years): 70
Maximum age (years): 76
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 5 years follow up
Secondary outcomes:
measure: General measurements
timeFrame: 1 year follow up, 3 years follow up, 5 years follow up
measure: Epigenetics
timeFrame: 1 year follow up, 3 years follow up, 5 years follow up
measure: Morbidity
timeFrame: 3 and 5 years
Other outcomes:
measure: Cognitive screening
timeFrame: 1 year follow up, 3 years follow up, 5 years follow ut
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Ulrik Wisløff, Professor
role: STUDY_CHAIR
References:
citation: Stensvold D, Viken H, Rognmo O, Skogvoll E, Steinshamn S, Vatten LJ, Coombes JS, Anderssen SA, Magnussen J, Ingebrigtsen JE, Fiatarone Singh MA, Langhammer A, Stoylen A, Helbostad JL, Wisloff 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.
citation: Viken H, Reitlo LS, Zisko N, Nauman J, Aspvik NP, Ingebrigtsen JE, Wisloff 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.
citation: Stensvold D, Viken H, Steinshamn SL, Dalen H, Stoylen A, Loennechen JP, Reitlo LS, Zisko N, Baekkerud FH, Tari AR, Sandbakk SB, Carlsen T, Ingebrigtsen JE, Lydersen S, Mattsson E, Anderssen SA, Fiatarone Singh MA, Coombes JS, Skogvoll E, Vatten LJ, Helbostad JL, Rognmo O, Wisloff U. Effect of exercise training for five years on all cause mortality in older adults-the Generation 100 study: randomised controlled trial. BMJ. 2020 Oct 7;371:m3485. doi: 10.1136/bmj.m3485.
citation: Letnes JM, Berglund I, Johnson KE, Dalen H, Nes BM, Lydersen S, Viken H, Hassel E, Steinshamn S, Vesterbekkmo EK, Stoylen A, Reitlo LS, Zisko N, Baekkerud FH, Tari AR, Ingebrigtsen JE, Sandbakk SB, Carlsen T, Anderssen SA, Singh MAF, Coombes JS, Helbostad JL, Rognmo O, Wisloff U, Stensvold D. Effect of 5 years of exercise training on the cardiovascular risk profile of older adults: the Generation 100 randomized trial. Eur Heart J. 2022 Jun 1;43(21):2065-2075. doi: 10.1093/eurheartj/ehab721.
citation: Zotcheva E, Haberg AK, Wisloff U, Salvesen O, Selbaek G, Stensvold D, Ernstsen L. Effects of 5 Years Aerobic Exercise on Cognition in Older Adults: The Generation 100 Study: A Randomized Controlled Trial. Sports Med. 2022 Jul;52(7):1689-1699. doi: 10.1007/s40279-021-01608-5. Epub 2021 Dec 8.
citation: Sokolowski DR, Hansen TI, Rise HH, Reitlo LS, Wisloff U, Stensvold D, Haberg AK. 5 Years of Exercise Intervention Did Not Benefit Cognition Compared to the Physical Activity Guidelines in Older Adults, but Higher Cardiorespiratory Fitness Did. A Generation 100 Substudy. Front Aging Neurosci. 2021 Nov 16;13:742587. doi: 10.3389/fnagi.2021.742587. eCollection 2021.
citation: Berglund I, Vesterbekkmo EK, Retterstol K, Anderssen SA, Fiatarone Singh MA, Helge JW, Lydersen S, Wisloff U, Stensvold D. The Long-term Effect of Different Exercise Intensities on High-Density Lipoprotein Cholesterol in Older Men and Women Using the Per Protocol Approach: The Generation 100 Study. Mayo Clin Proc Innov Qual Outcomes. 2021 Sep 16;5(5):859-871. doi: 10.1016/j.mayocpiqo.2021.07.002. eCollection 2021 Oct.