Clinical trial NCT04444661: Effects of COVID-19 Induced Deconditioning After Long-term High Intensity Resistance Exercise
Official title: Effects of COVID-19 Induced Deconditioning After Long-term High Intensity Resistance Exercise in Older Men With Osteosarcopenia A Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Sarcopenia
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: Friedrich-Alexander-Universität Erlangen-Nürnberg
First posted: 2020-06-23
Enrollment: 21
Sex: MALE
Minimum age (years): 74
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants of the FrOST study (men 72 years and older with osteosarcopenia)

Brief 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.


Eligibility criteria: Inclusion Criteria:

* participants of the FrOST study (NCT03453463)

Exclusion Criteria:

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

Primary outcomes:
measure: SMI
timeFrame: Change from Baseline to 26 weeks
Secondary outcomes:
measure: BMD-LS
timeFrame: Change from Baseline to 26 weeks
measure: BMD-hip
timeFrame: Change from Baseline to 26 weeks
measure: Sarcopenia-Z-Score
timeFrame: Change from Baseline to 26 weeks
measure: Fat infiltration thigh muscles
timeFrame: Change from Baseline to 26 weeks
measure: Fat infiltration para-vertebral muscles
timeFrame: Change from Baseline to 26 weeks
measure: Maximum hip-/leg extensor strength
timeFrame: Change from Baseline to 26 weeks
measure: Metabolic Syndrome Z-Score
timeFrame: Change from Baseline to 26 weeks
measure: Self rated physical performance
timeFrame: Change from Baseline to 26 weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg
state: Bavaria
Study officials:
affiliation: Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg
name: wolfgang Kemmler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kemmler W, Kohl M, Frohlich 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.
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.
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.