WHAT - Effectiveness of Physical Activity for Treatment of Hot Flushes Among Postmenopausal Women. A Randomized Controlled Pragmatic Pilot Study
The WHAT study is a pragmatic randomized controlled trial with two parallel arms. The
intervention is a 16 weeks individually tailored training programme with one hour physical
activity 2-3 times per week. Women randomized to the control group are asked to keep
physical activity at the same level as before the study.
Healthy postmenopausal women from Tromso will be recruited to the study by newspaper
advertisements and media coverage. Interested women are asked to make a call. A staff member
will ask about menopausal status, level of physical activity and diseases. Potential
participants will receive a diary by mail and will be asked to record frequency and severity
of hot-flashes, and duration of sleep at night for a period of 14 days. Women who return
this diary will be asked to sign the informed consent and complete a questionnaire, before
the fitness test. Baseline fitness is an important measure in this study. We will measure
VO2-max (maximal oxygen consumption) as a proxy for fitness. Whether you are randomized to
intervention or control group can influence the fitness test. The participants will
therefore be randomized after the fitness test.
Randomization: Unit of Applied Clinical Research, Institute of Cancer Research and Molecular
Medicine, Norwegian University of Science and Technology, Trondheim, Norway, will develop
and administrate a web-based randomization system for the WHAT pilot study. The data base
will be located at a server at the Medical Faculty at Norwegian University of Science and
Technology in Trondheim. The following staff are authorized to randomize people in WHAT
pilot study: Sameline Grimsgaard, Merethe Kumle, Sissel Andersen , Jorid Degerstrøm, Svein
In this pilot 50 women will be randomized either to intervention group (25 women) or control
group (25 women).
Elements in the intervention: A physiotherapist will based on interview and physical
examination make a plan for the 16 weeks physical activity programme for each participant.
The program will start with Pilates classes and low intensity aerobic training (2-4 weeks).
After this period, classes with moderate to high intensity aerobic training will be
introduced. The aim of the intervention is to increase aerobic capacity with 10 % from
Both the intervention group and the control group will receive questionnaires at baseline, 4
weeks, 8 weeks, 12 weeks, 16 weeks, 6 months and 1 year after inclusion. We will run the
test for physical fitness at baseline and 16 weeks.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in mean hot-flashes frequency and intensity (per 24/hours).
Potential participants receive a diary by mail and are asked to record frequency and severity of hot flashes and duration of sleep at night for a period of 14 subsequent days. During the study period the participants record frequency and intensity of hot flashes and duration of sleep at night for a period of 7 subsequent days at 4, 8, 12, 16 weeks and 6 months and one year.
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks , 6 months and 1 year
Sameline Grimsgaard, MD, PhD
University Hospital North Norway
Norway:National Committee for Medical and Health Research Ethics