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Exercise Effects on Sarco-Osteopenia in Older Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03453463
Recruitment Status : Completed
First Posted : March 5, 2018
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sarcopenia Osteopenia Other: exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessor are not aware of participant status and are nor allowed to ask correspondingly
Primary Purpose: Treatment
Official Title: Impact of Exercise on Sarco-osteopenia in Community Dwelling Men 70 Years and Older. A Randomized Controlled Trial
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : August 18, 2020
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


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 Name: resistance exercise

No Intervention: control
Calcium and Vitamin-D-supplementation (i.e. 800 mg/800 IE/d)



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. 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)

  3. 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

  4. Gait velocity [ Time Frame: changes from baseline to 6, 12 and 18 months ]
    Habitual gait speed over 10 m

  5. 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

  6. 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

  7. 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



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453463


Locations
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Germany
Institute of Medical Physics, University of Erlangen-Nürnberg, Germany
Erlangen, Germany, 91052
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Study Chair: Klaus Engelke, PhD Institute of Medical Physics, University of Erlangen-Nürnberg, Germany
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03453463    
Other Study ID Numbers: FROST
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Erlangen-Nürnberg Medical School:
sarcopenia
osteopenia
older men
community dwelling
physical functioning
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases