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Exercise and menopausal symptoms: a randomised controlled trial

The feasibility and acceptability of exercise as a treatment for vasomotor menopausal symptoms: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN06495625
Enrollment
165
Registered
2010-11-10
Start date
2011-01-01
Completion date
Unknown
Last updated
2020-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Primary Care Research Network for England

Interventions

Physical activity 1: Exercise consultations plus DVD and booklet, plus leaflets Physical activity 2: Exercise consultations plus support/information groups Control: Tre

Sponsors

University of Birmingham (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Feasibility (recruitment and adherence), measured at baseline and 6-month follow-up

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026