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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.
270 postmenopausal women will be included. Each woman will perform a 12 to 24 weeks sports program with supervised training exercises.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supervised training + immediate hormone substitution therapy per SOC | Experimental |
| |
| Supervised training + delayed hormone substitution therapy per SOC | Experimental |
| |
| Delayed supervised training + immediate hormone substitution therapy per SOC | Active Comparator |
| |
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise program | Other | The intervention consists of a supervised exercise program |
|
| 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 |
| 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 |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Herman Depypere | Contact | 003293323783 | studieco.vrouwenkliniek@uzgent.be | |
| Study coordinator Women's Clinic | Contact | 003293323783 | studieco.vrouwenkliniek@uzgent.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital - Women's Clinic | Recruiting | Ghent | 9000 | Belgium |
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| Hormonal substitution therapy per SOC | Drug | Subjects take hormonal substitution therapy per standard of care |
|
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 |
| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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