NCT05831709

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
May 2023Dec 2028

First Submitted

Initial submission to the registry

April 12, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

May 12, 2023

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

4.6 years

First QC Date

April 12, 2023

Last Update Submit

November 14, 2025

Conditions

PostmenopauseMenopausal Complaints

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Evaluation of the body composition

    +12 weeks; +24 weeks

  • Evaluation of the muscle mass

    +12 weeks; +24 weeks

Study Arms (6)

Supervised training + immediate hormone substitution therapy per SOC

EXPERIMENTAL
Other: Exercise programDrug: 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

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

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.

Interventions

Exercise programOTHER

The intervention consists of a supervised exercise program

Supervised trainingSupervised training + delayed hormone substitution therapy per SOCSupervised training + immediate hormone substitution therapy per SOC
Hormonal substitution therapy per SOCDRUG

Subjects take hormonal substitution therapy per standard of care

Delayed supervised training + immediate hormone substitution therapy per SOCSupervised training + immediate hormone substitution therapy per SOC

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital - Women's Clinic

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Herman Depypere

CONTACT

003293323783studieco.vrouwenkliniek@uzgent.be

Study coordinator Women's Clinic

CONTACT

003293323783studieco.vrouwenkliniek@uzgent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 26, 2023

Study Start

May 12, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)