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

NCT03959995 | Completed

• 1 other identifier: ER_ACTLIFE
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• BMD total Hip

  from baseline to 13 month follow-up

• Para-vertebral muscle density

  from baseline to 13 month follow-up

• Mid-thigh muscle density

  from baseline to 13 month follow-up

• Metabolic Syndrome

  from baseline to 13 month follow-up

• Visceral body fat

  from baseline to 13 month follow-up

Study Arms (2)

exercise

EXPERIMENTAL

Exercise group

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

control

SHAM COMPARATOR

active control group

Other: Wellness

Interventions

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.

exercise

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.

control

Eligibility Criteria

• Age: 48 Years - 58 Years
• Gender Eligibility Details: early postmenopausal
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg

Erlangen, Bavaria, 91052, Germany

Location

Related Publications (1)

• 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.

  PMID: 36685065 DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Health

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Michael Hettchen, MSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 22, 2019
• Study Start: January 15, 2019
• Primary Completion: March 13, 2020
• Study Completion: June 5, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)