Exercise Effects on Sarco-Osteopenia in Older Men

NCT ID: NCT03453463

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2020-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcopenia Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessor are not aware of participant status and are nor allowed to ask correspondingly

Study Groups

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exercise and protein supplementation

Predominately 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)

Group Type EXPERIMENTAL

exercise

Intervention Type OTHER

3x week predominately resistance exercise for 18 months

control

Calcium and Vitamin-D-supplementation (i.e. 800 mg/800 IE/d)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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exercise

3x week predominately resistance exercise for 18 months

Intervention Type OTHER

Other Intervention Names

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resistance exercise

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Klaus Engelke, PhD

Role: STUDY_CHAIR

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

Locations

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

Erlangen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 25963237 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29125144 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27108341 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38326734 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33408874 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33249320 (View on PubMed)

Other Identifiers

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FROST

Identifier Type: -

Identifier Source: org_study_id