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Completed

NCT Number: NCT04444661

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

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.

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Key information

Conditions

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

Age range

74 year–95 year

Sex eligibility

Male

Study type

Observational

Primary location

Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg

Erlangen, Bavaria, 91052, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • participants of the FrOST study (NCT03453463)

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. SMI

    Time frame: Change from Baseline to 26 weeks

    Skeletal muscle mass index (appendicular skeletal muscle mass / body height; kg/m2) as determined by Dual Energy x-Ray Absorptiometry

Secondary outcomes

  1. BMD-LS

    Time frame: Change from Baseline to 26 weeks

    Bone Mineral Density at the Lumbar Spine as determined by Dual Energy x-Ray Absorptiometry

  2. BMD-hip

    Time frame: Change from Baseline to 26 weeks

    Bone Mineral Density at the total hip as determined by Dual Energy x-Ray Absorptiometry

  3. Sarcopenia-Z-Score

    Time frame: Change from Baseline to 26 weeks

    Z-Score of parameters constituting the metabolic syndrome (i.e. SMI, hand-grip strength, gait velocity)

  4. Fat infiltration thigh muscles

    Time frame: Change from Baseline to 26 weeks

    Intramuscular adipose tissue at the mid thigh as determined by Magnetic Resonance Imaging

  5. Fat infiltration para-vertebral muscles

    Time frame: Change from Baseline to 26 weeks

    Intramuscular adipose tissue at the mid thigh as determined by Magnetic Resonance Imaging

  6. Maximum hip-/leg extensor strength

    Time frame: Change from Baseline to 26 weeks

    Maximum hip-/leg extensor strength as determined by an isokinetic leg press

  7. Metabolic Syndrome Z-Score

    Time frame: Change from Baseline to 26 weeks

    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)

  8. Self rated physical performance

    Time frame: Change from Baseline to 26 weeks

    Late-Life Function and Disability Index of McAuley et al.

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

  • Friedrich-Alexander-Universität Erlangen-Nürnberg

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 23, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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