Exercise Effects on Sarco-Osteopenia in Older Men

Not Applicable

Completed

• Conditions: Sarcopenia; Osteopenia
• Interventions: Other: exercise

• Registration Number: NCT03453463
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-15
• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-05
• Primary Completion: 2020-08-18
• Study Completion: 2020-10-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise and protein supplementation	exercise	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)

Primary Outcome Measures

Name	Time	Method
Lumbar spine Bone Mineral Density (QCT)	changes from baseline to 18 months	Lumbar spine Bone Mineral Density as determined by Quantitative Computed Tomography

Secondary Outcome Measures

Name	Time	Method
Lumbar spine Bone Mineral Density (DXA)	changes from baseline to 12 and 18 months	Lumbar spine Bone Mineral Density as determined by dual-energy x-ray absorptiometry (DXA)
Skeletal muscle mass index	changes from baseline to 6, 12 and 18 months	Skeletal muscle mass as defined fat and bone free mass of the limbs as determined by DXA divided by square height
Hip and leg extensor strength	changes from baseline to 6, 12 and 18 months	Maximum dynamic hip and leg extensor strength as determined by a isokinetic leg press
Gait velocity	changes from baseline to 6, 12 and 18 months	Habitual gait speed over 10 m
Hand-grip strength	changes from baseline to 6, 12 and 18 months	Maximum hand-grip strength of the dominant and non-dominant hand as assessed by a Jamar dynamometer
Femoral Neck Bone Mineral Density	changes from baseline to 12 and 18 months	Total hip Bone Mineral Density as determined by dual-energy x-ray absorptiometry (DXA)
Muscle Density at the calf, thigh and para-vertebral site	changes from baseline to 6 and 12 months	Muscle Density at the calf, thigh and para-vertebral site as assessed by MRI

Trial Locations

Locations (1)

Institute of Medical Physics, University of Erlangen-Nürnberg, Germany; 🇩🇪 Erlangen, Germany