Exercise and menopausal symptoms: a randomised controlled trial

ISRCTN	ISRCTN06495625
DOI	https://doi.org/10.1186/ISRCTN06495625
Secondary identifying numbers	8367

Submission date: 10/11/2010
Registration date: 10/11/2010
Last edited: 16/09/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Amanda Daley
Scientific

Department of Primary Care & General Practice
Primary Care Clinical Sciences Building
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	a.daley@bham.ac.uk

Study information

Study design	Single-centre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The feasibility and acceptability of exercise as a treatment for vasomotor menopausal symptoms: a randomised controlled trial
Study objectives	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(s)	West Midlands Local Research Ethics Committee, 04/02/2010, ref: 10/H1208/3a
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2011
Completion date	31/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Planned sample size: 165
Total final enrolment	261
Key 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
Key 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
Date of first enrolment	01/01/2011
Date of final enrolment	31/03/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Birmingham

Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Department of Primary Care & General Practice
Primary Care Clinical Sciences Building Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Website	http://www.birmingham.ac.uk/index.aspx
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Government

National Institute of Health Research (NIHR) (UK) - Research Capacity Development (ref: SRF/08/01/07)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/12/2013		Yes	No
Results article	results	01/03/2015		Yes	No
Results article	qualitative results	14/09/2020	16/09/2020	Yes	No

Editorial Notes

16/09/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the 2015 reference. RP 30/04/2015: added pub.