OsteoporosisNCT04444661
Effects of COVID-19 Induced Deconditioning After Long-term High Intensity Resistance Exercise
An observational study of Osteoporosis and Sarcopenia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Osteosarcopenia designates the simultaneous presence of sarcopenia and osteopenia; both chronic conditions of advanced age. Dynamic-resistance exercise (DRT) might be the most powerful agent to fight osteosarcopenia. Read more about this study
- Who is it for?
- Ages 74 to 95 years, men only
- Conditions the study is for
- Osteoporosis, Sarcopenia
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- 10 Jun 2020to 31 Dec 2020
- Phase
- Observational
- 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 74 to 95 years
- Men only
- No healthy volunteers
- Older adult
Study population: Participants of the FrOST study (men 72 years and older with osteosarcopenia)
Who may be able to join
- participants of the FrOST study (NCT03453463)
Who cannot join
- medication and diseases with potential impact on study outcomes during the last 26 weeks.
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 COVID-19 Induced Deconditioning After Long-term High Intensity Resistance Exercise in Older Men With Osteosarcopenia A Randomized Controlled Trial
Osteosarcopenia designates the simultaneous presence of sarcopenia and osteopenia; both chronic conditions of advanced age. Dynamic-resistance exercise (DRT) might be the most powerful agent to fight osteosarcopenia. Indeed, in the present FrOST study, we clearly determine the positive effect of slightly adapted 18 month high-intensity (HIT)-DRT on bone mineral density (BMD), sarcopenia and other health related parameters in osteosarcopenic men. However, after a short training break, COVID-19 induced lock down prevented a re-start of the HIT resistance exercise training in the FrOST cohort.
The aim of the present observational study is thus to determine the effects of 6 months of deconditioning on health related parameters under special regard of osteosarcopenia in this cohort of older men with osteosarcopenia.
- Conditions
- Osteoporosis, Sarcopenia
- Medical subject headings
- Osteoporosis, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIT-resistance exercise | High Intensity Resistance Exercise | |
| Non exercising control | Control group that maintained life style and physical activity habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
SMI
Skeletal muscle mass index (appendicular skeletal muscle mass / body height; kg/m2) as determined by Dual Energy x-Ray Absorptiometry
Measured: Change from Baseline to 26 weeks
Secondary outcomes (8)
BMD-LS
Bone Mineral Density at the Lumbar Spine as determined by Dual Energy x-Ray Absorptiometry
Measured: Change from Baseline to 26 weeks
BMD-hip
Bone Mineral Density at the total hip as determined by Dual Energy x-Ray Absorptiometry
Measured: Change from Baseline to 26 weeks
Sarcopenia-Z-Score
Z-Score of parameters constituting the metabolic syndrome (i.e. SMI, hand-grip strength, gait velocity)
Measured: Change from Baseline to 26 weeks
Fat infiltration thigh muscles
Intramuscular adipose tissue at the mid thigh as determined by Magnetic Resonance Imaging
Measured: Change from Baseline to 26 weeks
Fat infiltration para-vertebral muscles
Intramuscular adipose tissue at the mid thigh as determined by Magnetic Resonance Imaging
Measured: Change from Baseline to 26 weeks
Maximum hip-/leg extensor strength
Maximum hip-/leg extensor strength as determined by an isokinetic leg press
Measured: Change from Baseline to 26 weeks
Metabolic Syndrome Z-Score
Metabolic Syndrome Z-Score based on the definition of the International Diabetes Federation including waist circumference, resting glucose, HDL-cholesterol, triglyzerides, mean arterial blood pressure)
Measured: Change from Baseline to 26 weeks
Self rated physical performance
Late-Life Function and Disability Index of McAuley et al.
Measured: Change from Baseline to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start10 Jun 2020
- Primary completion11 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Responsible party
- Sponsor
- Investigators
- wolfgang Kemmler, PhD, Principal investigator, Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444661
- Sponsor's protocol ID
- FrOST-FU
- Status last verified
- Apr 2021
- First submitted
- 19 Jun 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study are available from the corresponding author, \[WK\], upon reasonable request.
Publications
Kemmler W, Kohl M, Frohlich M, Jakob F, Engelke K, von Stengel S, Schoene D. Effects of High-Intensity Resistance Training on Osteopenia and Sarcopenia Parameters in Older Men with Osteosarcopenia-One-Year Results of the Randomized Controlled Franconian Osteopenia and Sarcopenia Trial (FrOST). J Bone Miner Res. 2020 Sep;35(9):1634-1644. doi: 10.1002/jbmr.4027. Epub 2020 Apr 28.
PubMed 32270891Lichtenberg T, von Stengel S, Sieber C, Kemmler W. The Favorable Effects of a High-Intensity Resistance Training on Sarcopenia in Older Community-Dwelling Men with Osteosarcopenia: The Randomized Controlled FrOST Study. Clin Interv Aging. 2019 Dec 16;14:2173-2186. doi: 10.2147/CIA.S225618. eCollection 2019.
PubMed 31908428Kemmler W, Kohl M, Frohlich M, Schoene D, von Stengel S. Detraining effects after 18 months of high intensity resistance training on osteosarcopenia in older men-Six-month follow-up of the randomized controlled Franconian Osteopenia and Sarcopenia Trial (FrOST). Bone. 2021 Jan;142:115772. doi: 10.1016/j.bone.2020.115772. Epub 2020 Nov 26.
PubMed 33249320
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of COVID-19 Induced Deconditioning After Long-term High Intensity Resistance Exercise in Older Men With Osteosarcopenia A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04444661
- Acronym / sponsor ID
- FrOST-FU
- Conditions
- Osteoporosis, Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 23 Jun 2020 (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.
Osteosarcopenia designates the simultaneous presence of sarcopenia and osteopenia; both chronic conditions of advanced age. Dynamic-resistance exercise (DRT) might be the most powerful agent to fight osteosarcopenia. Indeed, in the present FrOST study, we clearly determine the positive effect of slightly adapted 18 month high-intensity (HIT)-DRT on bone mineral density (BMD), sarcopenia and other health related parameters in osteosarcopenic men. However, after a short training break, COVID-19 induced lock down prevented a re-start of the HIT resistance exercise training in the FrOST cohort.
The aim of the present observational study is thus to determine the effects of 6 months of deconditioning on health related parameters under special regard of osteosarcopenia in this cohort of older men with osteosarcopenia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIT-resistance exercise | – | –High Intensity Resistance Exercise |
| Non exercising control | – | –Control group that maintained life style and physical activity habits |
Who may qualify
- Ages
- 74 to 95 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Participants of the FrOST study (men 72 years and older with osteosarcopenia)
Key inclusion criteria (1 listed)
- participants of the FrOST study (NCT03453463)
Key exclusion criteria (1 listed)
- medication and diseases with potential impact on study outcomes during the last 26 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SMI
Time frame: Change from Baseline to 26 weeks
Skeletal muscle mass index (appendicular skeletal muscle mass / body height; kg/m2) as determined by Dual Energy x-Ray Absorptiometry
8 secondary outcomes
BMD-LS
Time frame: Change from Baseline to 26 weeks
BMD-hip
Time frame: Change from Baseline to 26 weeks
Sarcopenia-Z-Score
Time frame: Change from Baseline to 26 weeks
Fat infiltration thigh muscles
Time frame: Change from Baseline to 26 weeks
Fat infiltration para-vertebral muscles
Time frame: Change from Baseline to 26 weeks
Maximum hip-/leg extensor strength
Time frame: Change from Baseline to 26 weeks
Metabolic Syndrome Z-Score
Time frame: Change from Baseline to 26 weeks
Self rated physical performance
Time frame: Change from Baseline to 26 weeks
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 28 Apr 2021.
- Background: PubMed 32270891Kemmler W, Kohl M, Frohlich M, Jakob F, Engelke K, von Stengel S, Schoene D. Effects of High-Intensity Resistance Training on Osteopenia and Sarcopenia Parameters in Older Men with Osteosarcopenia-One-Year Results of the Randomized Controlled Franconian Osteopenia and Sarcopenia Trial (FrOST). J Bone Miner Res. 2020 Sep;35(9):1634-1644. doi: 10.1002/jbmr.4027. Epub 2020 Apr 28.
- Background: PubMed 31908428Lichtenberg T, von Stengel S, Sieber C, Kemmler W. The Favorable Effects of a High-Intensity Resistance Training on Sarcopenia in Older Community-Dwelling Men with Osteosarcopenia: The Randomized Controlled FrOST Study. Clin Interv Aging. 2019 Dec 16;14:2173-2186. doi: 10.2147/CIA.S225618. eCollection 2019.
- Derived from this study: PubMed 33249320Kemmler W, Kohl M, Frohlich M, Schoene D, von Stengel S. Detraining effects after 18 months of high intensity resistance training on osteosarcopenia in older men-Six-month follow-up of the randomized controlled Franconian Osteopenia and Sarcopenia Trial (FrOST). Bone. 2021 Jan;142:115772. doi: 10.1016/j.bone.2020.115772. Epub 2020 Nov 26.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study are available from the corresponding author, [WK], upon reasonable request.
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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.
wolfgang Kemmler, PhD principal investigator
Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Sarcopenia, 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 1 inclusion and 1 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 28 Apr 2021. 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. 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?
SMI (time frame: Change from Baseline to 26 weeks). 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 NCT04444661, which also lists 3 linked publications.
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 28 Apr 2021.