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

NCT04444661 | Completed

• 1 other identifier: FrOST-FU
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• BMD-LS

  Change from Baseline to 26 weeks

• BMD-hip

  Change from Baseline to 26 weeks

• Sarcopenia-Z-Score

  Change from Baseline to 26 weeks

• Fat infiltration thigh muscles

  Change from Baseline to 26 weeks

• Fat infiltration para-vertebral muscles

  Change from Baseline to 26 weeks

Study Arms (2)

HIT-resistance exercise

High Intensity Resistance Exercise

Non exercising control

Control group that maintained life style and physical activity habits

Eligibility Criteria

• Age: 74 Years - 95 Years
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• participants of the FrOST study (NCT03453463)

You may not qualify if:

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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Friedrich-Alexander-Universität Erlangen-Nürnberg: collaborator

Study Sites (1)

Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg

Erlangen, Bavaria, 91052, Germany

Location

Related Publications (3)

• 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.

  PMID: 32270891 BACKGROUND

• 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.

  PMID: 31908428 BACKGROUND

• 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

Osteoporosis; Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

• wolfgang Kemmler, PhD

  Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 23, 2020
• Study Start: June 10, 2020
• Primary Completion: November 11, 2020
• Study Completion: December 31, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: no limitation

Locations

DE (1)