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

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Osteoporosis

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91052
      • Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 74 years to 95 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Participants of the FrOST study (men 72 years and older with osteosarcopenia)

Description

Inclusion Criteria:

• participants of the FrOST study (NCT03453463)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HIT-resistance exercise; High Intensity Resistance Exercise
Non exercising control; Control group that maintained life style and physical activity habits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMD-LS	Bone Mineral Density at the Lumbar Spine as determined by Dual Energy x-Ray Absorptiometry	Change from Baseline to 26 weeks
BMD-hip	Bone Mineral Density at the total hip as determined by Dual Energy x-Ray Absorptiometry	Change from Baseline to 26 weeks
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
Fat infiltration thigh muscles	Intramuscular adipose tissue at the mid thigh as determined by Magnetic Resonance Imaging	Change from Baseline to 26 weeks
Fat infiltration para-vertebral muscles	Intramuscular adipose tissue at the mid thigh as determined by Magnetic Resonance Imaging	Change from Baseline to 26 weeks
Maximum hip-/leg extensor strength	Maximum hip-/leg extensor strength as determined by an isokinetic leg press	Change from Baseline to 26 weeks
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
Self rated physical performance	Late-Life Function and Disability Index of McAuley et al.	Change from Baseline to 26 weeks

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Collaborators: Friedrich-Alexander-Universität Erlangen-Nürnberg
• Investigators: Principal Investigator: wolfgang Kemmler, PhD, Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2020
• Primary Completion (Actual): November 11, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Bone Diseases; Muscular Atrophy; Atrophy; Bone Diseases, Metabolic; Sarcopenia; Osteoporosis
• Other Study ID Numbers: FrOST-FU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data that support the findings of this study are available from the corresponding author, [WK], upon reasonable request.
• IPD Sharing Time Frame: no limitation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No