Clinical trial NCT03959995: Effects of Physical Exercise on Postmenopausal Risk Factors in Women With Osteopenia
Official title: Effects of an Optimized 13-month Physical Exercise on (Early)-Postmenopausal Risk Factors in Women With Osteopenia and Osteoporosis (Actlife)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia, Osteoporosis
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 27
Sex: FEMALE
Minimum age (years): 48
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: BMD Lumbar Spine
timeFrame: from baseline to 13 month follow-up
Secondary outcomes:
measure: BMD total Hip
timeFrame: from baseline to 13 month follow-up
measure: Para-vertebral muscle density
timeFrame: from baseline to 13 month follow-up
measure: Mid-thigh muscle density
timeFrame: from baseline to 13 month follow-up
measure: Metabolic Syndrome
timeFrame: from baseline to 13 month follow-up
measure: Visceral body fat
timeFrame: from baseline to 13 month follow-up
measure: Total body fat
timeFrame: from baseline to 13 month follow-up
measure: Total Lean Body Mass
timeFrame: from baseline to 13 month follow-up
measure: Menopausal complaints
timeFrame: from baseline to 13 month follow-up
measure: Maximum leg strength
timeFrame: from baseline to 13 month follow-up
measure: Total fat rate
timeFrame: from baseline to 13 month follow-up
measure: Fat free mass
timeFrame: from baseline to 13 month follow-up
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg
state: Bavaria
Study officials:
affiliation: Institute of Medical Physics, University of Erlangen-Nürnberg, Germany
name: Michael Hettchen, MSc
role: PRINCIPAL_INVESTIGATOR
References: