Exercise Effects on Sarco-Osteopenia in Older Men

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453463
• Other study ID #: FROST
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: November 2020
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 1, 2020
• Est. primary completion date: August 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia
• Sarcopenia

Intervention

Other:
• exercise
3x week predominately resistance exercise for 18 months

Locations

Country	Name	City	State
Germany	Institute of Medical Physics, University of Erlangen-Nürnberg, Germany	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumbar spine Bone Mineral Density (QCT)	Lumbar spine Bone Mineral Density as determined by Quantitative Computed Tomography	changes from baseline to 18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Gait velocity	Habitual gait speed over 10 m	changes from baseline to 6, 12 and 18 months
Secondary	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
Secondary	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
Secondary	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