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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postmenopause; Menopausal Complaints
• Intervention / Treatment: Other: Exercise program; Drug: Hormonal substitution therapy per SOC

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Herman Depypere; Phone Number: 003293323783; Email: studieco.vrouwenkliniek@uzgent.be
• Study Contact Backup: Name: Study coordinator Women's Clinic; Phone Number: 003293323783; Email: studieco.vrouwenkliniek@uzgent.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital - Women's Clinic
    • Contact: Phone Number: +3293320758; Email: gynobs.studies@uzgent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supervised training + immediate hormone substitution therapy per SOC	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
Experimental: Supervised training + delayed hormone substitution therapy per SOC	Other: Exercise program; The intervention consists of a supervised exercise program
Active Comparator: Delayed supervised training + immediate hormone substitution therapy per SOC	Drug: Hormonal substitution therapy per SOC; Subjects take hormonal substitution therapy per standard of care
Experimental: Supervised training; 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.	Other: Exercise program; The intervention consists of a supervised exercise program
No Intervention: No supervised training; 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.
No Intervention: Control group; Subjects with menopausal complaints who do not want hormone substitution therapy or supervised training, can also participate in the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the cardiovascular risk	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.	+12 weeks; +24 weeks
Evaluation of the insulin sensitivity	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.	+12 weeks, +24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the body composition	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.	+12 weeks; +24 weeks
Evaluation of the muscle mass	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.	+12 weeks; +24 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Exercise; Resistance Training
• Other Study ID Numbers: ONZ-2023-0015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No