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

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ClinicalTrials.gov Identifier: NCT03959995
Recruitment Status : Active, not recruiting
First Posted : May 22, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Osteopenia, Osteoporosis Other: High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT) Other: Wellness Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Treatment
Official Title: Effects of an Optimized 18-month Physical Exercise on (Early)-Postmenopausal Risk Factors in Women With Osteopenia and Osteoporosis (Actlife)
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: exercise
Exercise group
Other: High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT)
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.

Sham Comparator: control
active control group
Other: Wellness
control group: 3x 10 week blocks, 1 training session/week à 45 min; stretching, light functional gymnastics, yoga with less strengthening techniques over 18 months.




Primary Outcome Measures :
  1. BMD Lumbar Spine [ Time Frame: from baseline to 18 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 :
  1. BMD total Hip [ Time Frame: from baseline to 18 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 18 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 18 month follow-up ]
    Muscle density at the mid-thigh region as determined by MRI

  4. Metabolic Syndrome [ Time Frame: from baseline to 18 month follow-up ]
    Metabolic Syndrome Z-Score according to the Internationale Diabetes Federation (IDF)

  5. Visceral body fat [ Time Frame: from baseline to 18 month follow-up ]
    Visceral body fat as determined by Magnetic Resonance Imaging (MRI)

  6. Total body fat [ Time Frame: from baseline to 18 month follow-up ]
    Total body fat as determined by whole body DXA

  7. Total Lean Body Mass [ Time Frame: from baseline to 18 month follow-up ]
    Total Lean Body Mass as determined by whole body DXA

  8. Menopausal complaints [ Time Frame: from baseline to 18 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 18 month follow-up ]
    Maximum isokinetic leg extensor strength as determined by an isokinetic leg press

  10. Total fat rate [ Time Frame: from baseline to 18 month follow-up ]
    Total fat rate as determined by Bio Impedance technique (BIA)

  11. Fat free mass [ Time Frame: from baseline to 18 month follow-up ]
    Fat free mass as determined by BIA



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Ages Eligible for Study:   48 Years to 58 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   early postmenopausal
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959995


Locations
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Germany
Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg
Erlangen, Bavaria, Germany, 91052
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Michael Hettchen, MSc Institute of Medical Physics, University of Erlangen-Nürnberg, Germany

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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03959995     History of Changes
Other Study ID Numbers: ER_ACTLIFE
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases