Effects of an Optimized 13-month Physical Exercise on (Early)-Postmenopausal Risk Factors in Women With Osteopenia and Osteoporosis (Actlife)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- BMD Lumbar Spine
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Blinding attempt of participants by sham exercise. Outcome assessors were unaware of participant's group status (exercise or control) and were not allowed to ask correspondingly.
Eligibility Criteria
- Ages
- 48 Years to 58 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(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)
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
BMD Lumbar Spine
Time Frame: 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 Outcomes
- Total body fat(from baseline to 13 month follow-up)
- BMD total Hip(from baseline to 13 month follow-up)
- Metabolic Syndrome(from baseline to 13 month follow-up)
- Total Lean Body Mass(from baseline to 13 month follow-up)
- Total fat rate(from baseline to 13 month follow-up)
- Fat free mass(from baseline to 13 month follow-up)
- Para-vertebral muscle density(from baseline to 13 month follow-up)
- Mid-thigh muscle density(from baseline to 13 month follow-up)
- Visceral body fat(from baseline to 13 month follow-up)
- Menopausal complaints(from baseline to 13 month follow-up)
- Maximum leg strength(from baseline to 13 month follow-up)