Exercise and menopausal symptoms: a randomised controlled trial

Not Applicable

Completed

• Conditions: Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases; Urological and Genital Diseases; Menopausal symptoms

• Registration Number: ISRCTN06495625
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-10
• Study Completion: 2012-03-31
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 261

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility (recruitment and adherence), measured at baseline and 6-month follow-up

Secondary Outcome Measures

Name	Time	Method
<br> 1. Depression, measured at baseline and 6-month follow-up<br> 2. Menopause-specific quality of life, measured at baseline and 6-month follow-up<br> 3. Physical activity (self report and objective), measured at baseline and 6-month follow-up<br> 4. Self efficacy for exercise, measured at baseline and 6-month follow-up<br> 5. Vasomotor symptoms, measured at baseline and 6-month follow-up<br>