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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorUniversity Hospital, Ghent

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise program

    Other intervention

    The intervention consists of a supervised exercise program

  • Hormonal substitution therapy per SOC

    Drug

    Subjects take hormonal substitution therapy per standard of care

Treatment groups

390 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Supervised training + immediate hormone substitution therapy per SOCExperimental treatment 2 interventions
Group B: Supervised training + delayed hormone substitution therapy per SOCExperimental treatment 1 intervention
Group C: Delayed supervised training + immediate hormone substitution therapy per SOCActive comparator 1 intervention
Group D: Supervised trainingExperimental treatment 1 intervention
Group E: No supervised trainingNo intervention 0 interventions
Group F: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
+12 weeks; +24 weeks
2

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.

Time frame
+12 weeks, +24 weeks

Secondary outcomes

1

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.

Time frame
+12 weeks; +24 weeks
2

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.

Time frame
+12 weeks; +24 weeks

Other outcomes

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