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Completed

NCT Number: NCT03959995

Effects of Physical Exercise on Postmenopausal Risk Factors in Women With Osteopenia

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.

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Key information

Conditions

Osteopenia, Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

48 year–58 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg

Erlangen, Bavaria, 91052, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT)

Other

Ambulatory, consistently supervised group exercise training (3 training sessions of 40-45 min/week each). 10-12-week blocks of non-linearly periodized high intensity resistance and high impact aerobic dance exercises (HIT-setting) intermitted by 4-6-week periods of endurance-type exercise with high volume and lower intensity. Indi-vidualized training schedules for the RT-section.

Wellness

Other

control group: 3x 10 week blocks, 1 training session/week à 45 min; stretching, light functional gymnastics, yoga with less strengthening techniques over 13 months.

Primary outcomes

  1. 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

  1. BMD total Hip

    Time frame: from baseline to 13 month follow-up

    Bone Mineral Density at the total hip region of interest as determined by DXA

  2. Para-vertebral muscle density

    Time frame: from baseline to 13 month follow-up

    Muscle density at the para-vertebral region as determined by Magnetic Resonance Imaging (MRI)

  3. Mid-thigh muscle density

    Time frame: from baseline to 13 month follow-up

    Muscle density at the mid-thigh region as determined by MRI

  4. Metabolic Syndrome

    Time frame: from baseline to 13 month follow-up

    Metabolic Syndrome Z-Score according to the Internationale Diabetes Federation (IDF)

  5. Visceral body fat

    Time frame: from baseline to 13 month follow-up

    Visceral body fat as determined by Magnetic Resonance Imaging (MRI)

  6. Total body fat

    Time frame: from baseline to 13 month follow-up

    Total body fat as determined by whole body DXA

  7. Total Lean Body Mass

    Time frame: from baseline to 13 month follow-up

    Total Lean Body Mass as determined by whole body DXA

  8. Menopausal complaints

    Time frame: 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)

  9. Maximum leg strength

    Time frame: from baseline to 13 month follow-up

    Maximum isokinetic leg extensor strength as determined by an isokinetic leg press

  10. Total fat rate

    Time frame: from baseline to 13 month follow-up

    Total fat rate as determined by Bio Impedance technique (BIA)

  11. Fat free mass

    Time frame: from baseline to 13 month follow-up

    Fat free mass as determined by BIA

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Effects of an Optimized 13-month Physical Exercise on (Early)-Postmenopausal Risk Factors in Women With Osteopenia and Osteoporosis (Actlife)

Acronym: ACTLIFE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 22, 2019
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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