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

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ClinicalTrials.gov Identifier: NCT04444661
Recruitment Status : Completed
First Posted : June 23, 2020
Last Update Posted : April 28, 2021
Sponsor:
Collaborator:
Friedrich-Alexander-Universität Erlangen-Nürnberg
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

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.


Condition or disease
Osteoporosis Sarcopenia

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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effects of COVID-19 Induced Deconditioning After Long-term High Intensity Resistance Exercise in Older Men With Osteosarcopenia A Randomized Controlled Trial
Actual Study Start Date : June 10, 2020
Actual Primary Completion Date : November 11, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   74 Years to 95 Years   (Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants of the FrOST study (men 72 years and older with osteosarcopenia)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04444661


Locations
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Germany
Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg
Erlangen, Bavaria, Germany, 91052
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Friedrich-Alexander-Universität Erlangen-Nürnberg
Investigators
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Principal Investigator: wolfgang Kemmler, PhD Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT04444661    
Other Study ID Numbers: FrOST-FU
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data that support the findings of this study are available from the corresponding author, [WK], upon reasonable request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: no limitation

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Sarcopenia
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical