Contact information
Type
Scientific
Primary contact
Dr Amanda Daley
ORCID ID
Contact details
Department of Primary Care & General Practice
Primary Care Clinical Sciences Building
Edgbaston
Birmingham
B15 2TT
United Kingdom
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a.daley@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8367
Study information
Scientific title
The feasibility and acceptability of exercise as a treatment for vasomotor menopausal symptoms: a randomised controlled trial
Acronym
Study hypothesis
Many menopausal women are keen to find alternatives to hormone replacement therapy (HRT); exercise might be a useful intervention in this regard. There has been a lack of robust research on the effects of exercise upon vasomotor symptoms as evidenced by our recent Cochrane review, which concluded that research in this field is very limited and of low quality. Our previous pilot work has already established that exercise is likely to be acceptable to menopausal aged women. In addition, we have now established women's preferences for different types of exercise and modes of delivery. We now need to determine the feasibility and acceptability of the preferred exercise interventions within the context of a randomised controlled trial (RCT). If exercise is shown to be feasible and subsequently effective in a phase III trial, then it would be possible for health professionals to discuss aerobic exercise as an evidence-based treatment option, specifically for the management of vasomotor symptoms.
We will conduct a three-arm RCT with women randomised to one of two exercise interventions or control. The interventions will last 6 months. The primary outcome will be feasibility (adherence and recruitment). Secondary outcomes include quality of life, depression and self-efficacy for exercise.
Ethics approval
West Midlands Local Research Ethics Committee, 04/02/2010, ref: 10/H1208/3a
Study design
Single-centre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
Intervention
Physical activity 1: Exercise consultations plus DVD and booklet, plus leaflets
Physical activity 2: Exercise consultations plus support/information groups
Control: Treatment as usual
Duration of treatment: 6 months
Duration of follow-up: 6 months from baseline (i.e. end of treatment)
Study entry: single randomisation only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Feasibility (recruitment and adherence), measured at baseline and 6-month follow-up
Secondary outcome measures
1. Depression, measured at baseline and 6-month follow-up
2. Menopause-specific quality of life, measured at baseline and 6-month follow-up
3. Physical activity (self report and objective), measured at baseline and 6-month follow-up
4. Self efficacy for exercise, measured at baseline and 6-month follow-up
5. Vasomotor symptoms, measured at baseline and 6-month follow-up
Overall trial start date
01/01/2011
Overall trial end date
31/03/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women aged 48 - 57 years who are experiencing vasomotor menopausal symptoms and have not used HRT in the previous 3 months
2. Spontaneously perimenopausal (irregular periods but at least one period in the previous 12 months) or menopausal women (no menstruation for greater than 12 months prior to study)
3. Inactive (not currently involved in a regular programme of exercise three or more times per week for at least 30 minutes per session during the previous 3 months)
4. Not dependent on illicit drugs or alcohol
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned sample size: 165
Total final enrolment
261
Participant exclusion criteria
1. Oral contraceptive, tamoxifen, tibolone and raloxifene usage in previous 3 months
2. Using HRT
3. Unable to provide informed consent
4. Not able to understand English sufficiently to complete the research questionnaires
5. GP considers patient unsuitable for the trial
Recruitment start date
01/01/2011
Recruitment end date
31/03/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Department of Primary Care & General Practice
Primary Care Clinical Sciences Building Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute of Health Research (NIHR) (UK) - Research Capacity Development (ref: SRF/08/01/07)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24070635
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25516405
2020 qualitative results in https://pubmed.ncbi.nlm.nih.gov/32928185/ (added 16/09/2020)
Publication citations
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Protocol
Daley AJ, Stokes-Lampard H, Thomas A, Rees M, Coleman S, Roalfe A, Hunter MS, MacArthur C, Aerobic exercise as a treatment for vasomotor menopausal symptoms: randomised controlled trial protocol., Maturitas, 2013, 76, 4, 350-356, doi: 10.1016/j.maturitas.2013.08.004.
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Results
Daley AJ, Thomas A, Roalfe AK, Stokes-Lampard H, Coleman S, Rees M, Hunter MS, MacArthur C, The effectiveness of exercise as treatment for vasomotor menopausal symptoms: randomised controlled trial, BJOG, 2015, 122, 4, 565-575, doi: 10.1111/1471-0528.13193.