Exercise Effects on Sarco-Osteopenia in Older Men

NCT03453463 | Completed

• 1 other identifier: FROST
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Osteopenia

Keywords

sarcopenia; osteopenia; older men; community dwelling; physical functioning

Outcome Measures

Primary Outcomes (1)

• Lumbar spine Bone Mineral Density (QCT)

  Lumbar spine Bone Mineral Density as determined by Quantitative Computed Tomography

  changes from baseline to 18 months

Secondary Outcomes (7)

• Lumbar spine Bone Mineral Density (DXA)

  changes from baseline to 12 and 18 months

• Femoral Neck Bone Mineral Density

  changes from baseline to 12 and 18 months

• Skeletal muscle mass index

  changes from baseline to 6, 12 and 18 months

• Gait velocity

  changes from baseline to 6, 12 and 18 months

• Hand-grip strength

  changes from baseline to 6, 12 and 18 months

Study Arms (2)

exercise and protein supplementation

EXPERIMENTAL

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

control

NO INTERVENTION

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

Interventions

exercise OTHER

3x week predominately resistance exercise for 18 months

Also known as: resistance exercise

exercise and protein supplementation

Eligibility Criteria

• Age: 70 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

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

Erlangen, 91052, Germany

Location

Related Publications (6)

• 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.

  PMID: 25963237 BACKGROUND

• 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.

  PMID: 29125144 BACKGROUND

• 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.

  PMID: 27108341 BACKGROUND

• Kircher K, Chaudry O, Nagel AM, Ghasemikaram M, Uder M, Jakob F, Kohl M, Kemmler W, Engelke K. Effects of high-intensity training on fatty infiltration in paraspinal muscles in elderly males with osteosarcopenia - the randomized controlled FrOST study. BMC Geriatr. 2024 Feb 8;24(1):141. doi: 10.1186/s12877-024-04736-5.

  PMID: 38326734 DERIVED

• 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.

  PMID: 33408874 DERIVED

• 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.

  PMID: 33249320 DERIVED

MeSH Terms

Conditions

Sarcopenia; Bone Diseases, Metabolic

Interventions

Exercise; Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Klaus Engelke, PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor are not aware of participant status and are nor allowed to ask correspondingly
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 5, 2018
• Study Start: January 15, 2018
• Primary Completion: August 18, 2020
• Study Completion: October 1, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

DE (1)