Osteopenia, OsteoporosisACTLIFENCT03959995
Effects of Physical Exercise on Postmenopausal Risk Factors in Women With Osteopenia
A study testing High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT) and Wellness in people with Osteopenia, Osteoporosis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 48 to 58 years, women only
- Conditions the study is for
- Osteopenia, Osteoporosis
- What is being tested?
- High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT) and Wellness
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jan 2019to 5 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 58 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- (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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg
Erlangen, Bavaria, 91052
About this study
Official title: 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.
Read more
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
- Being tested
- High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT), Wellness
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
WellnessOther
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.
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | Exercise group Receives: Other: High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT) |
| control | Sham comparator | active control group Receives: Other: Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMD Lumbar Spine
Bone Mineral Density (BMD) at the lumbar spine region of interest as determined by Dual Energy x-Ray Absorptiometry (DXA)
Measured: from baseline to 13 month follow-up
Secondary outcomes (11)
BMD total Hip
Bone Mineral Density at the total hip region of interest as determined by DXA
Measured: 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)
Measured: from baseline to 13 month follow-up
Mid-thigh muscle density
Muscle density at the mid-thigh region as determined by MRI
Measured: from baseline to 13 month follow-up
Metabolic Syndrome
Metabolic Syndrome Z-Score according to the Internationale Diabetes Federation (IDF)
Measured: from baseline to 13 month follow-up
Visceral body fat
Visceral body fat as determined by Magnetic Resonance Imaging (MRI)
Measured: from baseline to 13 month follow-up
Total body fat
Total body fat as determined by whole body DXA
Measured: from baseline to 13 month follow-up
Total Lean Body Mass
Total Lean Body Mass as determined by whole body DXA
Measured: 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)
Measured: from baseline to 13 month follow-up
Maximum leg strength
Maximum isokinetic leg extensor strength as determined by an isokinetic leg press
Measured: from baseline to 13 month follow-up
Total fat rate
Total fat rate as determined by Bio Impedance technique (BIA)
Measured: from baseline to 13 month follow-up
Fat free mass
Fat free mass as determined by BIA
Measured: from baseline to 13 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start15 Jan 2019
- Primary completion13 Mar 2020
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteopenia, OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Hettchen, MSc, Principal investigator, Institute of Medical Physics, University of Erlangen-Nürnberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959995
- Sponsor's protocol ID
- ER_ACTLIFE
- Acronym
- ACTLIFE
- Status last verified
- Jun 2020
- First submitted
- 20 May 2019
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36685065
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Optimized 13-month Physical Exercise on (Early)-Postmenopausal Risk Factors in Women With Osteopenia and Osteoporosis (Actlife)
- ClinicalTrials.gov ID
- NCT03959995
- Acronym / sponsor ID
- ACTLIFE / ER_ACTLIFE
- Conditions
- Osteopenia, Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Other: High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT)Exercise group |
| control | Sham comparator | Other: Wellnessactive control group |
Who may qualify
- Ages
- 48 to 58 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- (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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | exercise |
| Wellnesscontrol group: 3x 10 week blocks, 1 training session/week à 45 min; stretching, light functional gymnastics, yoga with less strengthening techniques over 13 months. | Other | control |
Primary outcome
BMD Lumbar Spine
Time frame: from baseline to 13 month follow-up
Bone Mineral Density (BMD) at the lumbar spine region of interest as determined by Dual Energy x-Ray Absorptiometry (DXA)
11 secondary outcomes
BMD total Hip
Time frame: from baseline to 13 month follow-up
Para-vertebral muscle density
Time frame: from baseline to 13 month follow-up
Mid-thigh muscle density
Time frame: from baseline to 13 month follow-up
Metabolic Syndrome
Time frame: from baseline to 13 month follow-up
Visceral body fat
Time frame: from baseline to 13 month follow-up
Total body fat
Time frame: from baseline to 13 month follow-up
Total Lean Body Mass
Time frame: from baseline to 13 month follow-up
Menopausal complaints
Time frame: from baseline to 13 month follow-up
Maximum leg strength
Time frame: from baseline to 13 month follow-up
Total fat rate
Time frame: from baseline to 13 month follow-up
Fat free mass
Time frame: from baseline to 13 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Derived from this study: PubMed 36685065Jungmann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Hettchen, MSc principal investigator
Institute of Medical Physics, University of Erlangen-Nürnberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT) and Wellness in people with Osteopenia, Osteoporosis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMD Lumbar Spine (time frame: from baseline to 13 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03959995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.