<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/NCT04420806</url>
  </required_header>
  <id_info>
    <org_study_id>ER_ACTLIFE_FU</org_study_id>
    <nct_id>NCT04420806</nct_id>
  </id_info>
  <brief_title>Effects of COVID-19 Lockdown in Exercising Early Postmenopausal Women</brief_title>
  <official_title>Effects of Three Months of COVID-19 Lockdown Induced Deconditioning After 13 Months of High Intensity Exercise Training in Early Postmenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      While &quot;conditioning&quot; by exercise training has been widely evaluated, the available literature&#xD;
      on &quot;passive deconditioning&quot; (i.e. forced deconditioning) is predominately limited to studies&#xD;
      with or with almost complete mechanical and/or metabolic immobilization/sedation of the&#xD;
      respective functional system (e.g. paralysis, bedriddenness). Vice versa, the effects of&#xD;
      moderately long interruptions of dedicated types of exercise while maintaining everyday&#xD;
      activity are rarely addressed. However, this topic is of high relevance, e.g. considering&#xD;
      that breaks of health-related exercise programs due to increased family/occupational stress,&#xD;
      vacation or temporary orthopedic limitation are rather frequent in everyday life. In the&#xD;
      present project we aimed to determine the effects of 3 months of physical deconditioning due&#xD;
      to COVID-19 induced lockdown after 13 month of high intensity endurance and resistance&#xD;
      exercise in early postmenopausal women on parameters related to health and physical fitness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 14, 2020</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>One exercise versus one control group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcomes assessors are unaware of participants group status and were not allowed to ask correspondingly</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Body composition</measure>
    <time_frame>From intervention end to 3 months FU</time_frame>
    <description>Body composition as determined by Dual-Energy x-Ray Absorptiometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hip-/Leg extension strength</measure>
    <time_frame>From intervention end to 3 months FU</time_frame>
    <description>Hip-/Leg extension strength as determined by an isokinetic leg press</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic Syndrome</measure>
    <time_frame>From intervention end to 3 months FU</time_frame>
    <description>cardio-metabolic risk factors summarized in the Metabolic Syndrome Z-Score according to the definition of the International Diabetes Federation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone Mineral Density (BMD)</measure>
    <time_frame>From intervention end to 3 months FU</time_frame>
    <description>BMD at the lumbar spine and total hip as determined by Dual Energy x-Ray Absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Menopausal symptoms</measure>
    <time_frame>From intervention end to 3 months FU</time_frame>
    <description>Menopausal symptoms as determined by the &quot;Menopausal Rating Scale&quot; (MRS) with a scale from 0 (no complaints) to 4 (very serious complaints).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Back and joint pain</measure>
    <time_frame>From intervention end to 3 months FU</time_frame>
    <description>Back and joint pain as determined by a standardized pain questionnaire with a scale from 0 (never) to 7 (permanent) for pain frequency or 0 (no pain) to 7 (extremely) for pain severity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Exercise</condition>
  <condition>Detraining</condition>
  <condition>Muscle Weakness</condition>
  <condition>Muscle Atrophy</condition>
  <arm_group>
    <arm_group_label>HIT-exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>13 months of high intensity endurance and resistance exercise - 3 months of exercise break</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>no exercise intervention that affect the present study outcomes</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HIT-exercise</intervention_name>
    <description>13 months of high intensity endurance and resistance exercise, 3x 45 min/week - 3 months of COVID-19 induced exercise break</description>
    <arm_group_label>HIT-exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham intervention</intervention_name>
    <description>Types of exercise (flexibility, relaxation) that did not affect the present outcomes</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (early)postmenopausal women, ( normal menopause, 1-5 years post)&#xD;
&#xD;
          -  Osteopenia and osteoporosis (Bone Mineral Density &lt;-1.0 SD T-Score)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMD &lt;-4.0 SD T-Score&#xD;
&#xD;
          -  Prevalent clinical, low-trauma fractures&#xD;
&#xD;
          -  Diseases and drugs with relevant effects on bone and muscle metabolism (e.g.&#xD;
             glucocorticoids &gt;7.5 mg/d or bisphosphonate therapy); individual case assessment&#xD;
&#xD;
          -  Diseases and drugs with relevant effects on cardiometabolic risk factors (e.g. severe&#xD;
             hypertension with corresponding medical therapy); individual case assessment&#xD;
&#xD;
          -  Severe cardiovascular events (e.g. stroke, coronary infarction) in the past.&#xD;
&#xD;
          -  Other conditions, diseases that exclude exercise training or testing&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>early postmenopausal status</gender_description>
    <minimum_age>48 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Hettchen, MSc</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-Alexanden University Erlangen-Nürnberg</name>
      <address>
        <city>Erlangen</city>
        <zip>91052</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>https://www.unibo.it/en/international/european-projects-of-education-and-training/actlife-physical-activity-the-tool-to-improve-the-quality-of-life-in-osteoporosis-people</url>
    <description>website of the ACTlife project</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>November 12, 2020</last_update_submitted>
  <last_update_submitted_qc>November 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</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>Muscle Weakness</mesh_term>
    <mesh_term>Muscular Atrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04420806
org study id: ER_ACTLIFE_FU
nct id: NCT04420806
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
While "conditioning" by exercise training has been widely evaluated, the available literature
      on "passive deconditioning" (i.e. forced deconditioning) is predominately limited to studies
      with or with almost complete mechanical and/or metabolic immobilization/sedation of the
      respective functional system (e.g. paralysis, bedriddenness). Vice versa, the effects of
      moderately long interruptions of dedicated types of exercise while maintaining everyday
      activity are rarely addressed. However, this topic is of high relevance, e.g. considering
      that breaks of health-related exercise programs due to increased family/occupational stress,
      vacation or temporary orthopedic limitation are rather frequent in everyday life. In the
      present project we aimed to determine the effects of 3 months of physical deconditioning due
      to COVID-19 induced lockdown after 13 month of high intensity endurance and resistance
      exercise in early postmenopausal women on parameters related to health and physical fitness.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: One exercise versus one control group
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcomes assessors are unaware of participants group status and were not allowed to ask correspondingly
measure: Body composition
time frame: From intervention end to 3 months FU
description: Body composition as determined by Dual-Energy x-Ray Absorptiometry
measure: Hip-/Leg extension strength
time frame: From intervention end to 3 months FU
description: Hip-/Leg extension strength as determined by an isokinetic leg press
measure: Metabolic Syndrome
time frame: From intervention end to 3 months FU
description: cardio-metabolic risk factors summarized in the Metabolic Syndrome Z-Score according to the definition of the International Diabetes Federation
measure: Bone Mineral Density (BMD)
time frame: From intervention end to 3 months FU
description: BMD at the lumbar spine and total hip as determined by Dual Energy x-Ray Absorptiometry
measure: Menopausal symptoms
time frame: From intervention end to 3 months FU
description: Menopausal symptoms as determined by the "Menopausal Rating Scale" (MRS) with a scale from 0 (no complaints) to 4 (very serious complaints).
measure: Back and joint pain
time frame: From intervention end to 3 months FU
description: Back and joint pain as determined by a standardized pain questionnaire with a scale from 0 (never) to 7 (permanent) for pain frequency or 0 (no pain) to 7 (extremely) for pain severity.
arm group label: HIT-exercise
arm group type: Active Comparator
description: 13 months of high intensity endurance and resistance exercise - 3 months of exercise break
arm group label: control
arm group type: Sham Comparator
description: no exercise intervention that affect the present study outcomes
intervention type: Other
intervention name: HIT-exercise
description: 13 months of high intensity endurance and resistance exercise, 3x 45 min/week - 3 months of COVID-19 induced exercise break
arm group label: HIT-exercise
intervention type: Other
intervention name: Sham intervention
description: Types of exercise (flexibility, relaxation) that did not affect the present outcomes
arm group label: control
criteria: 
gender: Female
gender based: Yes
gender description: early postmenopausal status
minimum age: 48 Years
maximum age: 60 Years
healthy volunteers: No
last name: Michael Hettchen, MSc
role: Principal Investigator
affiliation: Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg
facility: 
country: Germany
url: https://www.unibo.it/en/international/european-projects-of-education-and-training/actlife-physical-activity-the-tool-to-improve-the-quality-of-life-in-osteoporosis-people
description: website of the ACTlife project
responsible party type: Sponsor
mesh term: Muscle Weakness
mesh term: Muscular Atrophy
sharing ipd: Undecided