<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/NCT03030092</url>
  </required_header>
  <id_info>
    <org_study_id>Berg10069</org_study_id>
    <nct_id>NCT03030092</nct_id>
  </id_info>
  <brief_title>Maximal Strength Training Following Hip Fracture Surgery: Impact on Muscle Mass, Balance, Walking Efficiency and Bone Density</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Molde University College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Helse Nord-Trøndelag HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Molde University College</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      One group will receive today's standard rehabilitation program following hip fracture&#xD;
      surgery. The intervention group will have maximal strength training incorporated in their&#xD;
      program. It consists of 3 training sessions per week for 8 weeks, where 4-5 repetitions over&#xD;
      4 sets for leg press and abduction resistance exercise at ~85% of maximal strength is carried&#xD;
      out. Muscle strength, balance and bone density will be compared between the groups following&#xD;
      the 8-week rehabilitation period. The feasibility of the intervention for the patient group&#xD;
      will be evaluated based on compliance with training program and possible adverse events&#xD;
      related to the operated hip.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">June 2019</completion_date>
  <primary_completion_date type="Actual">June 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>8 weeks</time_frame>
    <description>1RM leg press, and hip abduction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Balance</measure>
    <time_frame>8 weeks</time_frame>
    <description>unipedal stance test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bone Density</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Today's standard care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Maximal Strength Training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Maximal Strength Training</intervention_name>
    <description>leg pres and abduction exercises</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age over 65, hip fracture surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  COPD, Heart failure, Dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03030092
org study id: Berg10069
nct id: NCT03030092
lead sponsor: 
collaborator: 
has dmc: No
One group will receive today's standard rehabilitation program following hip fracture
      surgery. The intervention group will have maximal strength training incorporated in their
      program. It consists of 3 training sessions per week for 8 weeks, where 4-5 repetitions over
      4 sets for leg press and abduction resistance exercise at ~85% of maximal strength is carried
      out. Muscle strength, balance and bone density will be compared between the groups following
      the 8-week rehabilitation period. The feasibility of the intervention for the patient group
      will be evaluated based on compliance with training program and possible adverse events
      related to the operated hip.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Muscle strength
time frame: 8 weeks
description: 1RM leg press, and hip abduction
measure: Balance
time frame: 8 weeks
description: unipedal stance test
measure: Bone Density
time frame: 8 weeks
arm group label: Control group
arm group type: No Intervention
description: Today's standard care
arm group label: Intervention group
arm group type: Experimental
description: Maximal Strength Training
intervention type: Other
intervention name: Maximal Strength Training
description: leg pres and abduction exercises
arm group label: Intervention group
criteria: 
gender: All
minimum age: 65 Years
maximum age: 95 Years
healthy volunteers: No
responsible party type: Sponsor
sharing ipd: No