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

NCT ID: NCT03959995

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2020-06-05

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.

Conditions

Osteopenia, Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

exercise

Exercise group

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

control

active control group

Group Type: SHAM_COMPARATOR

Wellness

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 48 Years
• Maximum Eligible Age: 58 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Hettchen, MSc

Role: PRINCIPAL_INVESTIGATOR

Institute of Medical Physics, University of Erlangen-Nürnberg, Germany

Locations

Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg

Erlangen, Bavaria, Germany

Countries

Germany

References

Jungmann S, Hettchen M, Kohl M, Kemmler W. Impact of 3 months of detraining after high intensity exercise on menopause-related symptoms in early postmenopausal women - results of the randomized controlled actlife project. Front Sports Act Living. 2023 Jan 5;4:1039754. doi: 10.3389/fspor.2022.1039754. eCollection 2022.

Reference Type: DERIVED

PMID: 36685065 (View on PubMed)

Other Identifiers

ER_ACTLIFE

Identifier Type: -

Identifier Source: org_study_id