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

University of Erlangen-Nürnberg Medical School1 site in 1 country43 target enrollmentJanuary 15, 2018

ConditionsSarcopenia Osteopenia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sarcopenia
Sponsor: University of Erlangen-Nürnberg Medical School
Enrollment: 43
Locations: 1
Primary Endpoint: Lumbar spine Bone Mineral Density (QCT)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 15, 2018

End Date

October 1, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

University of Erlangen-Nürnberg Medical School

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Lumbar spine Bone Mineral Density (QCT)

Time Frame: changes from baseline to 18 months

Lumbar spine Bone Mineral Density as determined by Quantitative Computed Tomography

Secondary Outcomes

Lumbar spine Bone Mineral Density (DXA)(changes from baseline to 12 and 18 months)
Skeletal muscle mass index(changes from baseline to 6, 12 and 18 months)
Hip and leg extensor strength(changes from baseline to 6, 12 and 18 months)
Gait velocity(changes from baseline to 6, 12 and 18 months)
Hand-grip strength(changes from baseline to 6, 12 and 18 months)
Femoral Neck Bone Mineral Density(changes from baseline to 12 and 18 months)
Muscle Density at the calf, thigh and para-vertebral site(changes from baseline to 6 and 12 months)