Clinical trial NCT03453463: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Osteopenia
Keywords: sarcopenia
osteopenia
older men
community dwelling
physical functioning
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 43
Sex: MALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Lumbar spine Bone Mineral Density (QCT)
timeFrame: changes from baseline to 18 months
Secondary outcomes:
measure: Lumbar spine Bone Mineral Density (DXA)
timeFrame: changes from baseline to 12 and 18 months
measure: Femoral Neck Bone Mineral Density
timeFrame: changes from baseline to 12 and 18 months
measure: Skeletal muscle mass index
timeFrame: changes from baseline to 6, 12 and 18 months
measure: Gait velocity
timeFrame: changes from baseline to 6, 12 and 18 months
measure: Hand-grip strength
timeFrame: changes from baseline to 6, 12 and 18 months
measure: Hip and leg extensor strength
timeFrame: changes from baseline to 6, 12 and 18 months
measure: Muscle Density at the calf, thigh and para-vertebral site
timeFrame: changes from baseline to 6 and 12 months
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics, University of Erlangen-Nürnberg, Germany
Study officials:
affiliation: Institute of Medical Physics, University of Erlangen-Nürnberg, Germany
name: Klaus Engelke, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.