<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04444661</url>
  </required_header>
  <id_info>
    <org_study_id>FrOST-FU</org_study_id>
    <nct_id>NCT04444661</nct_id>
  </id_info>
  <brief_title>Effects of COVID-19 Induced Deconditioning After Long-term High Intensity Resistance Exercise</brief_title>
  <official_title>Effects of COVID-19 Induced Deconditioning After Long-term High Intensity Resistance Exercise in Older Men With Osteosarcopenia A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Friedrich-Alexander-Universität Erlangen-Nürnberg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Erlangen-Nürnberg Medical School</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Osteosarcopenia designates the simultaneous presence of sarcopenia and osteopenia; both&#xD;
      chronic conditions of advanced age. Dynamic-resistance exercise (DRT) might be the most&#xD;
      powerful agent to fight osteosarcopenia. Indeed, in the present FrOST study, we clearly&#xD;
      determine the positive effect of slightly adapted 18 month high-intensity (HIT)-DRT on bone&#xD;
      mineral density (BMD), sarcopenia and other health related parameters in osteosarcopenic men.&#xD;
      However, after a short training break, COVID-19 induced lock down prevented a re-start of the&#xD;
      HIT resistance exercise training in the FrOST cohort.&#xD;
&#xD;
      The aim of the present observational study is thus to determine the effects of 6 months of&#xD;
      deconditioning on health related parameters under special regard of osteosarcopenia in this&#xD;
      cohort of older men with osteosarcopenia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">November 11, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>SMI</measure>
    <time_frame>Change from Baseline to 26 weeks</time_frame>
    <description>Skeletal muscle mass index (appendicular skeletal muscle mass / body height; kg/m2) as determined by Dual Energy x-Ray Absorptiometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BMD-LS</measure>
    <time_frame>Change from Baseline to 26 weeks</time_frame>
    <description>Bone Mineral Density at the Lumbar Spine as determined by Dual Energy x-Ray Absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMD-hip</measure>
    <time_frame>Change from Baseline to 26 weeks</time_frame>
    <description>Bone Mineral Density at the total hip as determined by Dual Energy x-Ray Absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sarcopenia-Z-Score</measure>
    <time_frame>Change from Baseline to 26 weeks</time_frame>
    <description>Z-Score of parameters constituting the metabolic syndrome (i.e. SMI, hand-grip strength, gait velocity)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat infiltration thigh muscles</measure>
    <time_frame>Change from Baseline to 26 weeks</time_frame>
    <description>Intramuscular adipose tissue at the mid thigh as determined by Magnetic Resonance Imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat infiltration para-vertebral muscles</measure>
    <time_frame>Change from Baseline to 26 weeks</time_frame>
    <description>Intramuscular adipose tissue at the mid thigh as determined by Magnetic Resonance Imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum hip-/leg extensor strength</measure>
    <time_frame>Change from Baseline to 26 weeks</time_frame>
    <description>Maximum hip-/leg extensor strength as determined by an isokinetic leg press</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic Syndrome Z-Score</measure>
    <time_frame>Change from Baseline to 26 weeks</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self rated physical performance</measure>
    <time_frame>Change from Baseline to 26 weeks</time_frame>
    <description>Late-Life Function and Disability Index of McAuley et al.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">21</enrollment>
  <condition>Osteoporosis</condition>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>HIT-resistance exercise</arm_group_label>
    <description>High Intensity Resistance Exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non exercising control</arm_group_label>
    <description>Control group that maintained life style and physical activity habits</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants of the FrOST study (men 72 years and older with osteosarcopenia)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  participants of the FrOST study (NCT03453463)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  medication and diseases with potential impact on study outcomes during the last 26&#xD;
             weeks.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>74 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>wolfgang Kemmler, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg</name>
      <address>
        <city>Erlangen</city>
        <state>Bavaria</state>
        <zip>91052</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <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>
    <PMID>32270891</PMID>
  </reference>
  <reference>
    <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>
    <PMID>31908428</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Sarcopenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data that support the findings of this study are available from the corresponding author, [WK], upon reasonable request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>no limitation</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04444661
org study id: FrOST-FU
nct id: NCT04444661
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Retrospective
measure: SMI
time frame: Change from Baseline to 26 weeks
description: Skeletal muscle mass index (appendicular skeletal muscle mass / body height; kg/m2) as determined by Dual Energy x-Ray Absorptiometry
measure: BMD-LS
time frame: Change from Baseline to 26 weeks
description: Bone Mineral Density at the Lumbar Spine as determined by Dual Energy x-Ray Absorptiometry
measure: BMD-hip
time frame: Change from Baseline to 26 weeks
description: Bone Mineral Density at the total hip as determined by Dual Energy x-Ray Absorptiometry
measure: Sarcopenia-Z-Score
time frame: Change from Baseline to 26 weeks
description: Z-Score of parameters constituting the metabolic syndrome (i.e. SMI, hand-grip strength, gait velocity)
measure: Fat infiltration thigh muscles
time frame: Change from Baseline to 26 weeks
description: Intramuscular adipose tissue at the mid thigh as determined by Magnetic Resonance Imaging
measure: Fat infiltration para-vertebral muscles
time frame: Change from Baseline to 26 weeks
description: Intramuscular adipose tissue at the mid thigh as determined by Magnetic Resonance Imaging
measure: Maximum hip-/leg extensor strength
time frame: Change from Baseline to 26 weeks
description: Maximum hip-/leg extensor strength as determined by an isokinetic leg press
measure: Metabolic Syndrome Z-Score
time frame: Change from Baseline to 26 weeks
description: 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)
measure: Self rated physical performance
time frame: Change from Baseline to 26 weeks
description: Late-Life Function and Disability Index of McAuley et al.
arm group label: HIT-resistance exercise
description: High Intensity Resistance Exercise
arm group label: Non exercising control
description: Control group that maintained life style and physical activity habits
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
gender based: Yes
minimum age: 74 Years
maximum age: 95 Years
healthy volunteers: No
last name: wolfgang Kemmler, PhD
role: Principal Investigator
affiliation: Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg
facility: 
country: Germany
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.
PMID: 32270891
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.
PMID: 31908428
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Sarcopenia
sharing ipd: Yes
ipd description: The data that support the findings of this study are available from the corresponding author, [WK], upon reasonable request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: no limitation