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Exercise Effects on Sarco-Osteopenia in Older Men

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03453463
Enrollment
43
Registered
2018-03-05
Start date
2018-01-15
Completion date
2020-10-01
Last updated
2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia, Sarcopenia

Keywords

sarcopenia, osteopenia, older men, community dwelling, physical functioning

Brief 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.

Interventions

OTHERexercise

3x week predominately resistance exercise for 18 months

Sponsors

University of Erlangen-Nürnberg Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
MALE
Age
70 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Lumbar spine Bone Mineral Density (QCT)changes from baseline to 18 monthsLumbar spine Bone Mineral Density as determined by Quantitative Computed Tomography

Secondary

MeasureTime frameDescription
Femoral Neck Bone Mineral Densitychanges from baseline to 12 and 18 monthsTotal hip Bone Mineral Density as determined by dual-energy x-ray absorptiometry (DXA)
Skeletal muscle mass indexchanges from baseline to 6, 12 and 18 monthsSkeletal muscle mass as defined fat and bone free mass of the limbs as determined by DXA divided by square height
Gait velocitychanges from baseline to 6, 12 and 18 monthsHabitual gait speed over 10 m
Lumbar spine Bone Mineral Density (DXA)changes from baseline to 12 and 18 monthsLumbar spine Bone Mineral Density as determined by dual-energy x-ray absorptiometry (DXA)
Hip and leg extensor strengthchanges from baseline to 6, 12 and 18 monthsMaximum dynamic hip and leg extensor strength as determined by a isokinetic leg press
Muscle Density at the calf, thigh and para-vertebral sitechanges from baseline to 6 and 12 monthsMuscle Density at the calf, thigh and para-vertebral site as assessed by MRI
Hand-grip strengthchanges from baseline to 6, 12 and 18 monthsMaximum hand-grip strength of the dominant and non-dominant hand as assessed by a Jamar dynamometer

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026