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

Study Overview
=================
Brief Summary
-----------------
This trial investigates whether supervised training in combination with hormonal substitution therapy has an impact on body composition, cardiovascular risk and insulin sensitivity in postmenopausal women.

Detailed Description
-----------------
90 postmenopausal women will be included. Each women will perform a 12 weeks sport program with supervised training exercises.

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

Conditions
-----------------
Postmenopause

Intervention / Treatment
-----------------
* Other: Exercise program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women Good general health BMI: 20-30 kg/m2 Only the use of cholesterol-, blood pressure- or/and thyroid-regulating medication is permitted Exclusion Criteria: Women who are not yet in the menopause BMI <20- and >30 kg/m2 Use of any other medication than cholesterol-, blood pressure- and thyroid-regulating medication

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised training + immediate hormone substitution therapy<br> | Other: Exercise program<br>* The intervention consists of a supervised exercise program<br>|
| Experimental: Supervised training + delayed hormone substitution therapy<br> | Other: Exercise program<br>* The intervention consists of a supervised exercise program<br>|
| Active Comparator: Delayed supervised training + immediate hormone substitution therapy<br> | Other: Exercise program<br>* The intervention consists of a supervised exercise program<br>|

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 two timepoints of measurement; once at inclusion and once at 12 weeks. | +12 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 two timepoints of measurement; once at inclusion and once at 12 weeks. | +12 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 twice; once at inclusion and once at 12 weeks. | +12 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 twice; once at inclusion and once at 12 weeks. | +12 weeks |