A randomised controlled study of the long-term effects of exercise training on mortality in elderly people: study protocol for the Generation 100 study

Dorthe Stensvold, Hallgeir Viken, Øivind Rognmo, Eirik Skogvoll, Sigurd Steinshamn, Lars J Vatten, Jeff S Coombes, Sigmund A Anderssen, Jon Magnussen, Jan Erik Ingebrigtsen, Maria A Fiatarone Singh, Arnulf Langhammer, Asbjørn Støylen, Jorunn L Helbostad, Ulrik Wisløff, Dorthe Stensvold, Hallgeir Viken, Øivind Rognmo, Eirik Skogvoll, Sigurd Steinshamn, Lars J Vatten, Jeff S Coombes, Sigmund A Anderssen, Jon Magnussen, Jan Erik Ingebrigtsen, Maria A Fiatarone Singh, Arnulf Langhammer, Asbjørn Støylen, Jorunn L Helbostad, Ulrik Wisløff

Abstract

Introduction: Epidemiological studies suggest that exercise has a tremendous preventative effect on morbidity and premature death, but these findings need to be confirmed by randomised trials. Generation 100 is a randomised, controlled study where the primary aim is to evaluate the effects of 5 years of exercise training on mortality in an elderly population.

Methods and analysis: All men and women born in the years 1936-1942 (n=6966), who were residents of Trondheim, Norway, were invited to participate. Between August 2012 and June 2013, a total of 1567 individuals (790 women) were included and randomised to either 5 years of two weekly sessions of high-intensity training (10 min warm-up followed by 4×4 min intervals at ∼90% of peak heart rate) or, moderate-intensity training (50 min of continuous work at ∼70% of peak heart rate), or to a control group that followed physical activity advice according to national recommendations. Clinical examinations, physical tests and questionnaires will be administered to all participants at baseline, and after 1, 3 and 5 years. Participants will also be followed up by linking to health registries until year 2035.

Ethics and dissemination: The study has been conducted according to the SPIRIT statement. All participants signed a written consent form, and the study has been approved by the Regional Committee for Medical Research Ethics, Norway. Projects such as this are warranted in the literature, and we expect that data from this study will result in numerous papers published in world-leading clinical journals; we will also present the results at international and national conferences.

Trial registration number: Clinicaltrials.gov NCT01666340.

Keywords: CLINICAL PHYSIOLOGY; PUBLIC HEALTH; SPORTS MEDICINE.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Figures

Figure 1
Figure 1
Flow chart of Generation 100.
Figure 2
Figure 2
Time points of assessments and the outcome variables measured.
Figure 3
Figure 3
Sample size and precision (expected width of the CI) for different mortality rates in the exercise group. The chosen number (750 in each group) is shown as a horizontal light grey line.

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