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

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: Menopausal Complaints; Postmenopause

Treatments: Other: Exercise program; Drug: Hormonal substitution therapy per SOC

Study type: Interventional

Funder types: Other

Identifiers

NCT05831709

ONZ-2023-0015

Details and patient eligibility

About

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.

Full description

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

Enrollment: 390 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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390 participants in 6 patient groups

Supervised training + immediate hormone substitution therapy per SOC

Experimental group

Treatment:

Drug: Hormonal substitution therapy per SOC

Other: Exercise program

Supervised training + delayed hormone substitution therapy per SOC

Experimental group

Treatment:

Other: Exercise program

Delayed supervised training + immediate hormone substitution therapy per SOC

Active Comparator group

Treatment:

Drug: Hormonal substitution therapy per SOC

Supervised training

Experimental group

Description:

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.

Treatment:

Other: Exercise program

No supervised training

No Intervention group

Description:

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 group

Description:

Subjects with menopausal complaints who do not want hormone substitution therapy or supervised training, can also participate in the trial.