Skip to main content
OpenTrials
Completed

NCT Number: NCT03453463

Exercise Effects on Sarco-Osteopenia in Older Men

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sarcopenia Atrophy Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Osteopenia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

70 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Medical Physics, University of Erlangen-Nürnberg, Germany

Erlangen, 91052, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

3x week predominately resistance exercise for 18 months

Other names: resistance exercise

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2018
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.