The Influence of Hormone Replacement Therapy and Supervised Exercise Training on Body Composition, Cardiovascular Risk and Insulin Sensitivity in Postmenopausal Women

NCT05831709 — Not applicable, Recruiting, 390 participants, University Hospital, Ghent

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De Invloed Van Hormoonsubstitutietherapie en Gesuperviseerde Training op Lichaamssamenstelling, Cardiovasculair Risico en Insulinegevoeligheid Bij Postmenopauzale Vrouwen

Registry	NCT05831709, acronym OPERATE
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, supportive care
Enrollment	390 (Estimated)
Sponsor	University Hospital, Ghent (Other)
Conditions	Postmenopause, Menopausal Complaints
Interventions	Exercise program, Hormonal substitution therapy per SOC (Other, drug)
Dates	start 2023-05-12, primary completion 2027-12-31 (estimated), completion 2028-12-01 (estimated), first posted 2023-04-26, last updated 2025-11-18
Locations	1 site in Belgium

-Summary

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.

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+Detailed description

270 postmenopausal women will be included. Each woman will perform a 12 to 24 weeks sports program with supervised training exercises.

+Arms and interventions

Arm	Type	Interventions	Description
Supervised training + immediate hormone substitution therapy per SOC	Experimental	Other: Exercise program; Drug: Hormonal substitution therapy per SOC
Supervised training + delayed hormone substitution therapy per SOC	Experimental	Other: Exercise program
Delayed supervised training + immediate hormone substitution therapy per SOC	Active comparator	Drug: Hormonal substitution therapy per SOC
Supervised training	Experimental	Other: Exercise program	Subjects who will start hormone substitution therapy in standard of care can participate in the trial and have 50% chance to be randomised in the exercise group.
No supervised training	No intervention		Subjects who will start hormone substitution therapy in standard of care can participate in the trial and have 50% chance to be randomised in the non-exercise group.
Control group	No intervention		Subjects with menopausal complaints who do not want hormone substitution therapy or supervised training, can also participate in the trial.

Exercise program (Other): The intervention consists of a supervised exercise program
Hormonal substitution therapy per SOC (Drug): Subjects take hormonal substitution therapy per standard of care

+Outcome measures

Primary outcomes

Evaluation of the cardiovascular risk [+12 weeks; +24 weeks]: The cardiovascular risk will be estimated by blood- and urine analysis, blood pressure and a AGE (i.e. Advanced Glycation End products)-reader. There are three timepoints of measurement; once at inclusion, once at 12 weeks, and once at 24 weeks.
Evaluation of the insulin sensitivity [+12 weeks, +24 weeks]: The insulin sensitivity will be estimated by blood- and urine analysis and a AGE (i.e. Advanced Glycation End products)-reader. There are three timepoints of measurement; once at inclusion, once at 12 weeks, and once at 24 weeks.

Secondary outcomes

Evaluation of the body composition [+12 weeks; +24 weeks]: The body composition will be measured using bioimpedance technology (Tanita-scale). The body composition will be measured three times; once at inclusion, once at 12 weeks and once at 24 weeks.
Evaluation of the muscle mass [+12 weeks; +24 weeks]: The musle mass will be evaluated by performing a maximal effort test (i.e. cycling test). This test will be performed three times; once at inclusion, once at 12 weeks, and once at 24 weeks.

+Eligibility

Sex: Female, ages: 45 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Ghent University Hospital - Women's Clinic	Ghent	Belgium	Recruiting

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