Exercise Effects on Sarco-Osteopenia in Older Men

• Sponsor: University of Erlangen-Nürnberg Medical School (Other)
• Overall Status: Completed
• CT.gov ID: NCT03453463
• Collaborator: (none)
• Enrollment: 43
• Location: 1
• Arms: 2
• Actual Duration (Months): 32.5
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia; Osteopenia	Other: exercise	N/A

Study Design

• Study Type: Interventional
• 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: Jan 15, 2018
• Actual Primary Completion Date: Aug 18, 2020
• Actual Study Completion Date: Oct 1, 2020

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Lumbar spine Bone Mineral Density (QCT) [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) [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 [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 [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 [changes from baseline to 6, 12 and 18 months]

   Habitual gait speed over 10 m

5. Hand-grip strength [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 [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 [changes from baseline to 6 and 12 months]

   Muscle Density at the calf, thigh and para-vertebral site as assessed by MRI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Medical Physics, University of Erlangen-Nürnberg, Germany	Erlangen		Germany	91052

Sponsors and Collaborators

• University of Erlangen-Nürnberg Medical School

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: University of Erlangen-Nürnberg Medical School
• ClinicalTrials.gov Identifier: NCT03453463
• Other Study ID Numbers: FROST
• First Posted: Mar 5, 2018
• Last Update Posted: Nov 4, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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: Bone Diseases, Metabolic; Sarcopenia

Study Results

No Results Posted as of Nov 4, 2020