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SarcopeniaNCT03453463

Exercise Effects on Sarco-Osteopenia in Older Men

A study testing exercise in people with Sarcopenia and Osteopenia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study determined the effects of predominately resistance type exercise in combination with protein supplements on parameters of sarcopenia and osteopenia (sarco-osteopenia) in older, community dwelling men with sarcopenia and -osteopenia over 18 months. Read more about this study

Who is it for?
Ages 70 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Sarcopenia, Osteopenia
What is being tested?
exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteGermany
Study dates
15 Jan 2018to 1 Oct 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 70 years and older
  • Men only
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Sarcopenia according to Baumgartner et al.(SMI: > -2 SD* T-Score)
  • Osteopenia at the lumbar spine or hip according to WHO (> -1 SD T-Score)
  • community dwelling people
  • able to transfer to our lab

Who cannot join

  • secondary osteoporosis
  • history of hip fracture
  • medication/diseases that relevantly affect muscle/bone metabolism (last 2 years)
  • alcohol abuses of more than 60 g/d ethanol
  • cardio-vascular diseases that prevent exercise
  • very low physical capacity that prevent exercise in a group setting
  • SD: Standard Deviation

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Erlangen, 91052

Other trials in Germany

About this study

Official title: Impact of Exercise on Sarco-osteopenia in Community Dwelling Men 70 Years and Older. A Randomized Controlled Trial

The study determined the effects of predominately resistance type exercise in combination with protein supplements on parameters of sarcopenia and osteopenia (sarco-osteopenia) in older, community dwelling men with sarcopenia and -osteopenia over 18 months.

Being tested
exercise
Keywords
sarcopenia, osteopenia, older men, community dwelling, physical functioning
Medical subject headings
Sarcopenia, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exerciseOther

    Also called resistance exercise

    3x week predominately resistance exercise for 18 months

Study groups in NCT03453463
Study groupRoleWhat they receive
exercise and protein supplementationExperimentalPredominately resistance exercise training 2-3x week for 18 months; 1.5-1.7 g/kg/d total protein supplementation, Calcium and Vitamin-D-supplementation (i.e. 800 mg/800 IE/d)
Receives: Other: exercise
controlNo interventionCalcium and Vitamin-D-supplementation (i.e. 800 mg/800 IE/d)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lumbar spine Bone Mineral Density (QCT)

    Lumbar spine Bone Mineral Density as determined by Quantitative Computed Tomography

    Measured: changes from baseline to 18 months

Secondary outcomes (7)

  1. Lumbar spine Bone Mineral Density (DXA)

    Lumbar spine Bone Mineral Density as determined by dual-energy x-ray absorptiometry (DXA)

    Measured: changes from baseline to 12 and 18 months

  2. Femoral Neck Bone Mineral Density

    Total hip Bone Mineral Density as determined by dual-energy x-ray absorptiometry (DXA)

    Measured: changes from baseline to 12 and 18 months

  3. Skeletal muscle mass index

    Skeletal muscle mass as defined fat and bone free mass of the limbs as determined by DXA divided by square height

    Measured: changes from baseline to 6, 12 and 18 months

  4. Gait velocity

    Habitual gait speed over 10 m

    Measured: changes from baseline to 6, 12 and 18 months

  5. Hand-grip strength

    Maximum hand-grip strength of the dominant and non-dominant hand as assessed by a Jamar dynamometer

    Measured: changes from baseline to 6, 12 and 18 months

  6. Hip and leg extensor strength

    Maximum dynamic hip and leg extensor strength as determined by a isokinetic leg press

    Measured: changes from baseline to 6, 12 and 18 months

  7. Muscle Density at the calf, thigh and para-vertebral site

    Muscle Density at the calf, thigh and para-vertebral site as assessed by MRI

    Measured: changes from baseline to 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2018
  2. Study start15 Jan 2018
  3. Primary completion18 Aug 2020
  4. Study completion1 Oct 2020

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03453463
Sponsor's protocol ID
FROST
Status last verified
Nov 2020
First submitted
26 Feb 2018
Last updated
4 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kemmler W, Bebenek M, Kohl M, von Stengel S. Exercise and fractures in postmenopausal women. Final results of the controlled Erlangen Fitness and Osteoporosis Prevention Study (EFOPS). Osteoporos Int. 2015 Oct;26(10):2491-9. doi: 10.1007/s00198-015-3165-3. Epub 2015 May 12.

    PubMed 25963237

  • Kemmler W, von Stengel S. Bone: High-intensity exercise to prevent fractures - risk or gain? Nat Rev Endocrinol. 2018 Jan;14(1):6-8. doi: 10.1038/nrendo.2017.148. Epub 2017 Nov 10. No abstract available.

    PubMed 29125144

  • Kemmler W, von Stengel S, Kohl M. Exercise frequency and bone mineral density development in exercising postmenopausal osteopenic women. Is there a critical dose of exercise for affecting bone? Results of the Erlangen Fitness and Osteoporosis Prevention Study. Bone. 2016 Aug;89:1-6. doi: 10.1016/j.bone.2016.04.019. Epub 2016 Apr 21.

    PubMed 27108341

  • Kircher K, Chaudry O, Nagel AM, Ghasemikaram M, Uder M, Jakob F, Kohl M, Kemmler W, Engelke K. Effects of high-intensity training on fatty infiltration in paraspinal muscles in elderly males with osteosarcopenia - the randomized controlled FrOST study. BMC Geriatr. 2024 Feb 8;24(1):141. doi: 10.1186/s12877-024-04736-5.

    PubMed 38326734

  • Kemmler W, Kohl M, von Stengel S, Schoene D. Effect of high-intensity resistance exercise on cardiometabolic health in older men with osteosarcopenia: the randomised controlled Franconian Osteopenia and Sarcopenia Trial (FrOST). BMJ Open Sport Exerc Med. 2020 Dec 24;6(1):e000846. doi: 10.1136/bmjsem-2020-000846. eCollection 2020.

    PubMed 33408874

  • Kemmler 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

Questions about this trial

What is this clinical trial studying?

A study testing exercise in people with Sarcopenia and Osteopenia, 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 4 inclusion and 7 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 4 Nov 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. 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?

Lumbar spine Bone Mineral Density (QCT) (time frame: changes from baseline to 18 months). 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 NCT03453463, which also lists 6 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 4 Nov 2020.

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