<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/NCT02218970</url>
  </required_header>
  <id_info>
    <org_study_id>2012/640</org_study_id>
    <nct_id>NCT02218970</nct_id>
  </id_info>
  <brief_title>The Effect of Muscular Strength Training in Patients With Drug Addiction</brief_title>
  <official_title>The Effect of Muscular Strength Training in Patients With Drug Addiction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Physical health does not have a high priority in today's treatment of patients with substance&#xD;
      use disorder (SUD). SUD patients have a poor physical health not only due to injuries related&#xD;
      to the substance abuse, but also because of the addiction-related lifestyle. There are few&#xD;
      studies today that provide information about SUD patient's physical health, and especially&#xD;
      there is little information about their muscular strength. One of the project's aims is to&#xD;
      measure muscular strength in SUD patients who are being treated for their addiction, and see&#xD;
      if they have decreased neuromuscular function. If so, we will investigate the effect of&#xD;
      maximal strength training on neuromuscular function in these patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">June 2014</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>10 weeks</time_frame>
    <description>Assessed peripheral muscle strength by one repetition maximum test (1RM)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Substance-related Disorders</condition>
  <arm_group>
    <arm_group_label>strength training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Strength training for leg muscles during10 weeks, 3 times a week: hack squat and plantar flexion, standing upright in a hack squat machine and lying down in a calf rise machine. Exercises will be carried out at 85% of 1-RM intensity under supervision at the institution where participants are having their SUD treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients treated for substance-related disorder but not participating in strength training intervention (no training control group)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>strength training</intervention_name>
    <arm_group_label>strength training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>no training (control)</intervention_name>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being treated for drug abuse&#xD;
&#xD;
          -  not using drugs during intervention period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participated in strength training in previous 6 months&#xD;
&#xD;
          -  cardiovascular disease&#xD;
&#xD;
          -  any other disease that impedes to finish tests&#xD;
&#xD;
          -  not showing up for testing sessions&#xD;
&#xD;
          -  carried out less than 85% of planned exercise sessions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Grete Flemmen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rusbehandling Midt-Norge H</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <results_reference>
    <citation>Unhjem R, Flemmen G, Hoff J, Wang E. Maximal strength training as physical rehabilitation for patients with substance use disorder; a randomized controlled trial. BMC Sports Sci Med Rehabil. 2016 Mar 31;8:7. doi: 10.1186/s13102-016-0032-2. eCollection 2016.</citation>
    <PMID>27042312</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>May 11, 2020</last_update_submitted>
  <last_update_submitted_qc>May 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rehabilitation</keyword>
  <keyword>strength training</keyword>
  <keyword>muscle strength</keyword>
  <keyword>physical fitness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT02218970
org study id: 2012/640
nct id: NCT02218970
lead sponsor: 
has dmc: No
Physical health does not have a high priority in today's treatment of patients with substance
      use disorder (SUD). SUD patients have a poor physical health not only due to injuries related
      to the substance abuse, but also because of the addiction-related lifestyle. There are few
      studies today that provide information about SUD patient's physical health, and especially
      there is little information about their muscular strength. One of the project's aims is to
      measure muscular strength in SUD patients who are being treated for their addiction, and see
      if they have decreased neuromuscular function. If so, we will investigate the effect of
      maximal strength training on neuromuscular function in these patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: muscle strength
time frame: 10 weeks
description: Assessed peripheral muscle strength by one repetition maximum test (1RM)
arm group label: strength training
arm group type: Experimental
description: Strength training for leg muscles during10 weeks, 3 times a week: hack squat and plantar flexion, standing upright in a hack squat machine and lying down in a calf rise machine. Exercises will be carried out at 85% of 1-RM intensity under supervision at the institution where participants are having their SUD treatment.
arm group label: control
arm group type: Other
description: patients treated for substance-related disorder but not participating in strength training intervention (no training control group)
intervention type: Behavioral
intervention name: strength training
arm group label: strength training
intervention type: Behavioral
intervention name: no training (control)
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Grete Flemmen
role: Principal Investigator
affiliation: Norwegian University of Science and Technology
facility: 
country: Norway
citation: Unhjem R, Flemmen G, Hoff J, Wang E. Maximal strength training as physical rehabilitation for patients with substance use disorder; a randomized controlled trial. BMC Sports Sci Med Rehabil. 2016 Mar 31;8:7. doi: 10.1186/s13102-016-0032-2. eCollection 2016.
PMID: 27042312
responsible party type: Sponsor
mesh term: Substance-Related Disorders