NCT03453463CompletedNot Applicable
Impact of Exercise on Sarco-osteopenia in Community Dwelling Men 70 Years and Older. A Randomized Controlled Trial
University of Erlangen-Nürnberg Medical School2 sites in 1 country43 target enrollmentStarted: January 15, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 43
- Locations
- 2
- Primary Endpoint
- Lumbar spine Bone Mineral Density (QCT)
Study 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.
Study Design
- Study Type
- Interventional
- 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 Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- Male
- Accepts 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
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)
Investigators
Study Sites (2)
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