Exercise Effects on Sarco-Osteopenia in Older Men

November 3, 2020 updated by: University of Erlangen-Nürnberg Medical School

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91052
        • Institute of Medical Physics, University of Erlangen-Nurnberg, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
changes from baseline to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lumbar spine Bone Mineral Density (DXA)
Time Frame: changes from baseline to 12 and 18 months
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
Time Frame: changes from baseline to 12 and 18 months
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
Time Frame: 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
changes from baseline to 6, 12 and 18 months
Gait velocity
Time Frame: changes from baseline to 6, 12 and 18 months
Habitual gait speed over 10 m
changes from baseline to 6, 12 and 18 months
Hand-grip strength
Time Frame: 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
changes from baseline to 6, 12 and 18 months
Hip and leg extensor strength
Time Frame: changes from baseline to 6, 12 and 18 months
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
Time Frame: changes from baseline to 6 and 12 months
Muscle Density at the calf, thigh and para-vertebral site as assessed by MRI
changes from baseline to 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Investigators

  • Study Chair: Klaus Engelke, PhD, Institute of Medical Physics, University of Erlangen-Nurnberg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2018

Primary Completion (Actual)

August 18, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

February 26, 2018

First Submitted That Met QC Criteria

March 2, 2018

First Posted (Actual)

March 5, 2018

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FROST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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