Effects of COVID-19 Induced Deconditioning After Long-term High Intensity Resistance Exercise

Osteoporosis Clinical Trial

Official title:

Effects of COVID-19 Induced Deconditioning After Long-term High Intensity Resistance Exercise in Older Men With Osteosarcopenia A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04444661
• Other study ID #: FrOST-FU
• Status: Completed
• Start date: June 10, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Osteosarcopenia designates the simultaneous presence of sarcopenia and osteopenia; both chronic conditions of advanced age. Dynamic-resistance exercise (DRT) might be the most powerful agent to fight osteosarcopenia. Indeed, in the present FrOST study, we clearly determine the positive effect of slightly adapted 18 month high-intensity (HIT)-DRT on bone mineral density (BMD), sarcopenia and other health related parameters in osteosarcopenic men. However, after a short training break, COVID-19 induced lock down prevented a re-start of the HIT resistance exercise training in the FrOST cohort.

The aim of the present observational study is thus to determine the effects of 6 months of deconditioning on health related parameters under special regard of osteosarcopenia in this cohort of older men with osteosarcopenia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 31, 2020
• Est. primary completion date: November 11, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 74 Years to 95 Years

Eligibility

Inclusion Criteria:

• participants of the FrOST study (NCT03453463)

Exclusion Criteria:

• medication and diseases with potential impact on study outcomes during the last 26 weeks.

Related Conditions & MeSH terms

• Osteoporosis
• Sarcopenia

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Friedrich-Alexander-Universität Erlangen-Nürnberg

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Kemmler W, Kohl M, Fröhlich M, Jakob F, Engelke K, von Stengel S, Schoene D. Effects of High-Intensity Resistance Training on Osteopenia and Sarcopenia Parameters in Older Men with Osteosarcopenia-One-Year Results of the Randomized Controlled Franconian Osteopenia and Sarcopenia Trial (FrOST). J Bone Miner Res. 2020 Sep;35(9):1634-1644. doi: 10.1002/jbmr.4027. Epub 2020 Apr 28. — View Citation

Lichtenberg T, von Stengel S, Sieber C, Kemmler W. The Favorable Effects of a High-Intensity Resistance Training on Sarcopenia in Older Community-Dwelling Men with Osteosarcopenia: The Randomized Controlled FrOST Study. Clin Interv Aging. 2019 Dec 16;14:2173-2186. doi: 10.2147/CIA.S225618. eCollection 2019. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SMI	Skeletal muscle mass index (appendicular skeletal muscle mass / body height; kg/m2) as determined by Dual Energy x-Ray Absorptiometry	Change from Baseline to 26 weeks
Secondary	BMD-LS	Bone Mineral Density at the Lumbar Spine as determined by Dual Energy x-Ray Absorptiometry	Change from Baseline to 26 weeks
Secondary	BMD-hip	Bone Mineral Density at the total hip as determined by Dual Energy x-Ray Absorptiometry	Change from Baseline to 26 weeks
Secondary	Sarcopenia-Z-Score	Z-Score of parameters constituting the metabolic syndrome (i.e. SMI, hand-grip strength, gait velocity)	Change from Baseline to 26 weeks
Secondary	Fat infiltration thigh muscles	Intramuscular adipose tissue at the mid thigh as determined by Magnetic Resonance Imaging	Change from Baseline to 26 weeks
Secondary	Fat infiltration para-vertebral muscles	Intramuscular adipose tissue at the mid thigh as determined by Magnetic Resonance Imaging	Change from Baseline to 26 weeks
Secondary	Maximum hip-/leg extensor strength	Maximum hip-/leg extensor strength as determined by an isokinetic leg press	Change from Baseline to 26 weeks
Secondary	Metabolic Syndrome Z-Score	Metabolic Syndrome Z-Score based on the definition of the International Diabetes Federation including waist circumference, resting glucose, HDL-cholesterol, triglyzerides, mean arterial blood pressure)	Change from Baseline to 26 weeks
Secondary	Self rated physical performance	Late-Life Function and Disability Index of McAuley et al.	Change from Baseline to 26 weeks