Exercise Effects on Sarco-Osteopenia in Older Men

Study Overview
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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.

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

Conditions
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Sarcopenia, Osteopenia

Intervention / Treatment
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* Other: exercise


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise and protein supplementation<br>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) | Other: exercise<br>* 3x week predominately resistance exercise for 18 months<br>* Other names: resistance exercise;|
| No Intervention: control<br>Calcium and Vitamin-D-supplementation (i.e. 800 mg/800 IE/d) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumbar spine Bone Mineral Density (QCT) | Lumbar spine Bone Mineral Density as determined by Quantitative Computed Tomography | changes from baseline to 18 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sarcopenia, osteopenia, older men, community dwelling, physical functioning