The Influence of Hormone Replacement Therapy and Supervised Exercise Training on Body Composition, Cardiovascular Risk and Insulin Sensitivity in Postmenopausal Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise program, Hormonal substitution therapy per SOC.
- Who it may be relevant to
- Registry conditions: Postmenopause, Menopausal Complaints. Basic parameters: 45 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
De Invloed Van Hormoonsubstitutietherapie en Gesuperviseerde Training op Lichaamssamenstelling, Cardiovasculair Risico en Insulinegevoeligheid Bij Postmenopauzale Vrouwen
Overview
This trial investigates whether supervised training in combination with hormonal substitution therapy has an impact on body composition, cardiovascular risk, risk for dementia, osteoporosis and insulin sensitivity in postmenopausal women.
Detailed description
270 postmenopausal women will be included. Each woman will perform a 12 to 24 weeks sports program with supervised training exercises.
Interventions
- Other Exercise program
The intervention consists of a supervised exercise program - Drug Hormonal substitution therapy per SOC
Subjects take hormonal substitution therapy per standard of care
Primary outcome measures
- Evaluation of the cardiovascular risk [Time frame: +12 weeks; +24 weeks]
- Evaluation of the insulin sensitivity [Time frame: +12 weeks, +24 weeks]
Secondary outcome measures (2)
- Evaluation of the body composition [Time frame: +12 weeks; +24 weeks]
- Evaluation of the muscle mass [Time frame: +12 weeks; +24 weeks]
Eligibility criteria
Inclusion criteria
- Postmenopausal women (diagnosed by physician) with complaints due to menopause
- Indication for hormonal substitution therapy (except for the control group)
- Good general health
- BMI: 20-30 kg/m2
- Only the use of cholesterol-, blood pressure- or/and thyroid-regulating medication is permitted
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Belgium · 1 center
- Ghent University Hospital - Women's Clinic — Ghent
Identifiers
NCT: NCT05831709 · ONZ-2023-0015