Effects of Physical Exercise on Postmenopausal Risk Factors in Women With Osteopenia
- Conditions
- Osteopenia, Osteoporosis
- Interventions
- Other: High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT)Other: Wellness
- Registration Number
- NCT03959995
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Brief Summary
Menopause usually have a serious impact on a woman's life, associated with negative consequences for health and quality of life. Early preventive assessments are very difficult to implement due to the complex hormone-deficiency-induced effects on a large variety of organs and systems with estrogen receptors. In fact, only a few types of interventions have the potential to comprehensively improve the various risk factors and complaints of the menopausal transition. In detail, however, not every form of exercise training or every training protocol is effective for exerting positive effects on selected risk factors. In particular, the training concept for addressing musculoskeletal or cardio-metabolic risk factors differ fundamentally.
In several studies, we confirmed the effect of different complex training programs on risk factors of different postmenopausal female cohorts with special consideration of osteoporotic aspects. The training programs applied in this context were characterized by the consistent implementation of recognized training principles and an in general exercise intensity-oriented approach. Recent studies confirmed the effectiveness of this proceeding for women with relevant postmenopausal risk factors including low bone strength. However, the crucial issue of the most effective, feasible and easily customizable training protocol for addressing postmenopausal risk factors remains to be answered, taking into account that the majority of exercise programs were realized in an ambulatory group setting.
The aim of the study will be to evaluate the effects of an optimized physical training on risk factors and complaints of (early) postmenopausal women with special consideration of the osseous fracture risk.
Note (05.06.2020): Of importance, the intervention has to be cancelled due to COVID-19 lockdown in March 2020 after 13 months of intervention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 27
- (early)postmenopausal women, ( normal menopause, 1-5 years post)
- Osteopenia and osteoporosis at the lumbar spine or femoral neck Bone Mineral Density (BMD) <-1.0 standard deviation (SD) T-Score, WHO)
- BMD <-4.0 SD T-Score (BMD threshold for pharmaceutical therapy according to Dachverband Osteologie (DVO) guideline (mandatory for Germany, Austria, Suisse) for woman 50-60 years).
- Prevalent clinical, low-trauma fractures
- Diseases and drugs with relevant effects on bone and muscle metabolism (e.g. glucocorticoids >7.5 mg/d or bisphosphonate therapy); individual case assessment
- Diseases and drugs with relevant effects on cardiometabolic risk factors (e.g. severe hypertension with corresponding medical therapy); individual case assessment
- Severe cardiovascular events (e.g. stroke, coronary infarction) in the past.
- Other conditions, diseases that exclude exercise training in a group (≤10 persons).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description exercise High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT) Exercise group control Wellness active control group
- Primary Outcome Measures
Name Time Method BMD Lumbar Spine from baseline to 13 month follow-up Bone Mineral Density (BMD) at the lumbar spine region of interest as determined by Dual Energy x-Ray Absorptiometry (DXA)
- Secondary Outcome Measures
Name Time Method Total Lean Body Mass from baseline to 13 month follow-up Total Lean Body Mass as determined by whole body DXA
Total fat rate from baseline to 13 month follow-up Total fat rate as determined by Bio Impedance technique (BIA)
BMD total Hip from baseline to 13 month follow-up Bone Mineral Density at the total hip region of interest as determined by DXA
Metabolic Syndrome from baseline to 13 month follow-up Metabolic Syndrome Z-Score according to the Internationale Diabetes Federation (IDF)
Fat free mass from baseline to 13 month follow-up Fat free mass as determined by BIA
Para-vertebral muscle density from baseline to 13 month follow-up Muscle density at the para-vertebral region as determined by Magnetic Resonance Imaging (MRI)
Mid-thigh muscle density from baseline to 13 month follow-up Muscle density at the mid-thigh region as determined by MRI
Visceral body fat from baseline to 13 month follow-up Visceral body fat as determined by Magnetic Resonance Imaging (MRI)
Total body fat from baseline to 13 month follow-up Total body fat as determined by whole body DXA
Menopausal complaints from baseline to 13 month follow-up Menopausal complaints as determined by the Menopause Rating Scale (German version. Questionnaire with 11 items; scale from 0 (no complaints/problems) to 4 (very severe complaints/problem)
Maximum leg strength from baseline to 13 month follow-up Maximum isokinetic leg extensor strength as determined by an isokinetic leg press
Trial Locations
- Locations (1)
Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg
🇩🇪Erlangen, Bavaria, Germany