NCT03959995: ACTLIFE

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

Completed NA Last updated 9 June 2020

What this trial tests

NA trial testing High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT) in Osteopenia, Osteoporosis in 27 participants. Completed in 5 June 2020.

Timeline

15 January 2019

Primary endpoint
13 March 2020

5 June 2020

Quick facts

Lead sponsor	University of Erlangen-Nürnberg Medical School
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	27
Start date	15 January 2019
Primary completion	13 March 2020
Estimated completion	5 June 2020
Sites	1 location across Germany

Drugs / interventions tested

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

Conditions studied

• Osteopenia, Osteoporosis — all drugs for Osteopenia, Osteoporosis →

Sponsor

University of Erlangen-Nürnberg Medical School

Who can join

Adults 48 to 58, female only, with Osteopenia, Osteoporosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Changes in Menopausal Risk Factors in Early Postmenopausal Osteopenic Women After 13 Months of High-Intensity Exercise: The Randomized Controlled ACTLIFE-RCT.
   Hettchen M, von Stengel S, Kohl M, Murphy MH, et al · · 2021 · cited 32× · PMID 33469276 · DOI 10.2147/cia.s283177
2. 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.
   Jungmann S, Hettchen M, Kohl M, Kemmler W. · · 2022 · cited 3× · PMID 36685065 · DOI 10.3389/fspor.2022.1039754