NCT01666340

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,567

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

August 21, 2012

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

5.8 years

First QC Date

August 8, 2012

Last Update Submit

September 8, 2025

Conditions

Keywords

ExerciseElderlyMortalityMorbidityPrognosisLongevity

Outcome Measures

Primary Outcomes (1)

  • Mortality

    using data from governmental registers

    5 years follow up

Secondary Outcomes (4)

  • General measurements

    1 year follow up, 3 years follow up, 5 years follow up

  • Epigenetics

    1 year follow up, 3 years follow up, 5 years follow up

  • Morbidity

    3 and 5 years

  • Mortality and Morbidity

    10 years

Other Outcomes (1)

  • Cognitive screening

    1 year follow up, 3 years follow up, 5 years follow ut

Study Arms (2)

high intensity aerobic training

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

Other: Exercise intervention

Moderate intensity training

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

Other: Exercise intervention

Interventions

Group asked to perform exercise at a given moderate intensity for a set time

Also known as: Moderate training
Moderate intensity traininghigh intensity aerobic training

Eligibility Criteria

Age70 Years - 76 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Born in 1936, 1937, 1938, 1939, 1940, 1941 or 1942
  • Able to complete the exercise program (determined by the researchers).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, 7006, Norway

Location

Related Publications (11)

  • 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.

    PMID: 25678546BACKGROUND
  • 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.

    PMID: 30113524BACKGROUND
  • 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.

  • 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.

  • Bakken J, Brissach DE, Ingestrom EML, Midttun S, Walker TL, Stensvold D, Tari AR. Effects of 5-Year Exercise Training on Cognition in Older Adults: 10-Years Follow-Up from the Generation 100 Study. Sports Med Open. 2025 Dec 7;11(1):153. doi: 10.1186/s40798-025-00956-0.

  • Hallan SI, Ovrehus MA, Shlipak MG, Potok OA, Romundstad S, Aspvik NP, Wisloff U, Ix JH, Stensvold D, Langlo KA. Long-Term Physical Exercise for Preventing CKD in Older Adults: A Randomized Clinical Trial. J Am Soc Nephrol. 2025 Feb 11;36(7):1352-1362. doi: 10.1681/ASN.0000000636.

  • Tari AR, Brissach DE, Ingestrom EML, Nauman J, Tyrell T, Foster C, Radtke K, Porcari JP, Lydersen S, Kaminsky LA, Myers J, Walker TL, Coombes JS, Stensvold D, Wisloff U. Survival of the fittest? Peak oxygen uptake and all-cause mortality among older adults in Norway. Prog Cardiovasc Dis. 2025 Mar-Apr;89:25-34. doi: 10.1016/j.pcad.2024.11.004. Epub 2024 Dec 4.

  • Reitlo LS, Mihailovic JM, Stensvold D, Wisloff U, Hyder F, Haberg AK. Hippocampal neurochemicals are associated with exercise group and intensity, psychological health, and general cognition in older adults. Geroscience. 2023 Jun;45(3):1667-1685. doi: 10.1007/s11357-022-00719-9. Epub 2023 Jan 10.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ulrik Wisløff, Professor

    Norwegian University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 16, 2012

Study Start

August 21, 2012

Primary Completion

June 1, 2018

Study Completion (Estimated)

June 1, 2026

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations