search
Back to results

Exercise Effects on Sarco-Osteopenia in Older Men

Primary Purpose

Sarcopenia, Osteopenia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
exercise
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring sarcopenia, osteopenia, older men, community dwelling, physical functioning

Eligibility Criteria

70 Years - undefined (Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

exercise and protein supplementation

control

Arm Description

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)

Calcium and Vitamin-D-supplementation (i.e. 800 mg/800 IE/d)

Outcomes

Primary Outcome Measures

Lumbar spine Bone Mineral Density (QCT)
Lumbar spine Bone Mineral Density as determined by Quantitative Computed Tomography

Secondary Outcome Measures

Lumbar spine Bone Mineral Density (DXA)
Lumbar spine Bone Mineral Density as determined by dual-energy x-ray absorptiometry (DXA)
Femoral Neck Bone Mineral Density
Total hip Bone Mineral Density as determined by dual-energy x-ray absorptiometry (DXA)
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
Gait velocity
Habitual gait speed over 10 m
Hand-grip strength
Maximum hand-grip strength of the dominant and non-dominant hand as assessed by a Jamar dynamometer
Hip and leg extensor strength
Maximum dynamic hip and leg extensor strength as determined by a isokinetic leg press
Muscle Density at the calf, thigh and para-vertebral site
Muscle Density at the calf, thigh and para-vertebral site as assessed by MRI

Full Information

First Posted
February 26, 2018
Last Updated
November 3, 2020
Sponsor
University of Erlangen-Nürnberg Medical School
search

1. Study Identification

Unique Protocol Identification Number
NCT03453463
Brief Title
Exercise Effects on Sarco-Osteopenia in Older Men
Official Title
Impact of Exercise on Sarco-osteopenia in Community Dwelling Men 70 Years and Older. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
August 18, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Osteopenia
Keywords
sarcopenia, osteopenia, older men, community dwelling, physical functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessor are not aware of participant status and are nor allowed to ask correspondingly
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
exercise and protein supplementation
Arm Type
Experimental
Arm Description
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)
Arm Title
control
Arm Type
No Intervention
Arm Description
Calcium and Vitamin-D-supplementation (i.e. 800 mg/800 IE/d)
Intervention Type
Other
Intervention Name(s)
exercise
Other Intervention Name(s)
resistance exercise
Intervention Description
3x week predominately resistance exercise for 18 months
Primary Outcome Measure Information:
Title
Lumbar spine Bone Mineral Density (QCT)
Description
Lumbar spine Bone Mineral Density as determined by Quantitative Computed Tomography
Time Frame
changes from baseline to 18 months
Secondary Outcome Measure Information:
Title
Lumbar spine Bone Mineral Density (DXA)
Description
Lumbar spine Bone Mineral Density as determined by dual-energy x-ray absorptiometry (DXA)
Time Frame
changes from baseline to 12 and 18 months
Title
Femoral Neck Bone Mineral Density
Description
Total hip Bone Mineral Density as determined by dual-energy x-ray absorptiometry (DXA)
Time Frame
changes from baseline to 12 and 18 months
Title
Skeletal muscle mass index
Description
Skeletal muscle mass as defined fat and bone free mass of the limbs as determined by DXA divided by square height
Time Frame
changes from baseline to 6, 12 and 18 months
Title
Gait velocity
Description
Habitual gait speed over 10 m
Time Frame
changes from baseline to 6, 12 and 18 months
Title
Hand-grip strength
Description
Maximum hand-grip strength of the dominant and non-dominant hand as assessed by a Jamar dynamometer
Time Frame
changes from baseline to 6, 12 and 18 months
Title
Hip and leg extensor strength
Description
Maximum dynamic hip and leg extensor strength as determined by a isokinetic leg press
Time Frame
changes from baseline to 6, 12 and 18 months
Title
Muscle Density at the calf, thigh and para-vertebral site
Description
Muscle Density at the calf, thigh and para-vertebral site as assessed by MRI
Time Frame
changes from baseline to 6 and 12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Engelke, PhD
Organizational Affiliation
Institute of Medical Physics, University of Erlangen-Nürnberg, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Medical Physics, University of Erlangen-Nürnberg, Germany
City
Erlangen
ZIP/Postal Code
91052
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25963237
Citation
Kemmler W, Bebenek M, Kohl M, von Stengel S. Exercise and fractures in postmenopausal women. Final results of the controlled Erlangen Fitness and Osteoporosis Prevention Study (EFOPS). Osteoporos Int. 2015 Oct;26(10):2491-9. doi: 10.1007/s00198-015-3165-3. Epub 2015 May 12.
Results Reference
background
PubMed Identifier
29125144
Citation
Kemmler W, von Stengel S. Bone: High-intensity exercise to prevent fractures - risk or gain? Nat Rev Endocrinol. 2018 Jan;14(1):6-8. doi: 10.1038/nrendo.2017.148. Epub 2017 Nov 10. No abstract available.
Results Reference
background
PubMed Identifier
27108341
Citation
Kemmler W, von Stengel S, Kohl M. Exercise frequency and bone mineral density development in exercising postmenopausal osteopenic women. Is there a critical dose of exercise for affecting bone? Results of the Erlangen Fitness and Osteoporosis Prevention Study. Bone. 2016 Aug;89:1-6. doi: 10.1016/j.bone.2016.04.019. Epub 2016 Apr 21.
Results Reference
background
PubMed Identifier
33408874
Citation
Kemmler W, Kohl M, von Stengel S, Schoene D. Effect of high-intensity resistance exercise on cardiometabolic health in older men with osteosarcopenia: the randomised controlled Franconian Osteopenia and Sarcopenia Trial (FrOST). BMJ Open Sport Exerc Med. 2020 Dec 24;6(1):e000846. doi: 10.1136/bmjsem-2020-000846. eCollection 2020.
Results Reference
derived
PubMed Identifier
33249320
Citation
Kemmler W, Kohl M, Frohlich M, Schoene D, von Stengel S. Detraining effects after 18 months of high intensity resistance training on osteosarcopenia in older men-Six-month follow-up of the randomized controlled Franconian Osteopenia and Sarcopenia Trial (FrOST). Bone. 2021 Jan;142:115772. doi: 10.1016/j.bone.2020.115772. Epub 2020 Nov 26.
Results Reference
derived

Learn more about this trial

Exercise Effects on Sarco-Osteopenia in Older Men

We'll reach out to this number within 24 hrs