Condition category
Urological and Genital Diseases
Date applied
10/11/2010
Date assigned
10/11/2010
Last edited
30/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
-
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 measures

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

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

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

http://www.birmingham.ac.uk/index.aspx

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

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24070635
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25516405

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes