Aerobic exercise as a treatment for vasomotor menopausal symptoms: Randomised controlled trial protocol
Stokes-Lampard H., Thomas A., Rees M., Coleman S., Roalfe A., Hunter MS., MacArthur C.
Background Evidence suggests that a high proportion of perimenopausal and postmenopausal women experience vasomotor symptoms (hot flushes/night sweats) that can be severe and disruptive and which are the principal reason for seeking medical intervention. Hormone therapy (HT) is known to be an effective treatment for troublesome hot flushes/night sweats but research has raised questions about the safety of HT and there have been negative high profile media reports about its use. Consequently many women are seeking alternatives and exercise might be one such option but there is a lack of high quality evidence on its effectiveness. Aims This RCT initially aims to investigate the feasibility/acceptability of two exercise interventions identified from our previous preference study in 165 women, and if found to be feasible/acceptable, continue to recruit sufficient women (n = 261) to examine the effect of these interventions on hot flushes/night sweats and other outcomes relevant to menopausal women. Method We aim to recruit inactive perimenopausal and menopausal symptomatic women not using HT and randomise them to one of two exercise interventions or usual care for six months. Results We will assess outcomes at baseline and 6 and 12 months from randomisation. Conclusion We hope this RCT will contribute towards increasing the evidence regarding the question of whether exercise is an effective treatment for vasomotor symptoms in women not taking HT. © 2013 Elsevier Ireland Ltd. All rights reserved.