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

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

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 Overview

• Status: Completed
• Conditions: Osteopenia, Osteoporosis
• Intervention / Treatment: Other: High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT); Other: Wellness

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91052
      • Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 58 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 13 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMD Lumbar Spine	Bone Mineral Density (BMD) at the lumbar spine region of interest as determined by Dual Energy x-Ray Absorptiometry (DXA)	from baseline to 13 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMD total Hip	Bone Mineral Density at the total hip region of interest as determined by DXA	from baseline to 13 month follow-up
Para-vertebral muscle density	Muscle density at the para-vertebral region as determined by Magnetic Resonance Imaging (MRI)	from baseline to 13 month follow-up
Mid-thigh muscle density	Muscle density at the mid-thigh region as determined by MRI	from baseline to 13 month follow-up
Metabolic Syndrome	Metabolic Syndrome Z-Score according to the Internationale Diabetes Federation (IDF)	from baseline to 13 month follow-up
Visceral body fat	Visceral body fat as determined by Magnetic Resonance Imaging (MRI)	from baseline to 13 month follow-up
Total body fat	Total body fat as determined by whole body DXA	from baseline to 13 month follow-up
Total Lean Body Mass	Total Lean Body Mass as determined by whole body DXA	from baseline to 13 month follow-up
Menopausal complaints	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)	from baseline to 13 month follow-up
Maximum leg strength	Maximum isokinetic leg extensor strength as determined by an isokinetic leg press	from baseline to 13 month follow-up
Total fat rate	Total fat rate as determined by Bio Impedance technique (BIA)	from baseline to 13 month follow-up
Fat free mass	Fat free mass as determined by BIA	from baseline to 13 month follow-up

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Principal Investigator: Michael Hettchen, MSc, Institute of Medical Physics, University of Erlangen-Nurnberg, Germany

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2019
• Primary Completion (ACTUAL): March 13, 2020
• Study Completion (ACTUAL): June 5, 2020

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (ACTUAL): May 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Osteoporosis; Bone Diseases, Metabolic
• Other Study ID Numbers: ER_ACTLIFE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No