<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/NCT04496934</url>
  </required_header>
  <id_info>
    <org_study_id>2013/00731</org_study_id>
    <nct_id>NCT04496934</nct_id>
  </id_info>
  <brief_title>Physical Activity as Adjunct Treatment for Opioid Substitution Therapy</brief_title>
  <official_title>Physical Activity as Adjunct Treatment for Opioid Substitution Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kristiania University College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bergen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Western Norway University of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Solli Distriktspsykiatriske Senter</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Haukeland University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In terms of research, it is documented that exercise has a positive effect on mental&#xD;
      disorders. Studies have shown positive correlations between physical and mental health, also&#xD;
      among substance users. Such a study has never been performed on patients in opioid&#xD;
      substitution therapy (OST). Documentation on the physical health of patients and the effect&#xD;
      of exercise is very limited. Treatment of substance users is a research area with&#xD;
      insufficient knowledge about certain treatment effects. It is important that a treatment can&#xD;
      both support and promote the user's own resources and efforts to change their habits of&#xD;
      substance use.&#xD;
&#xD;
      The objective of this project is to examine the effect of exercise for OST patients, measured&#xD;
      in relation to cognitive function and physical form. The target group consists of OST&#xD;
      patients from 18 years of age and up, of both sexes, and on stable medication. At least 60&#xD;
      participants should complete the project, which is designed as a controlled randomized study&#xD;
      (RCT). Participants in the intervention group start to exercise immediately after baseline&#xD;
      testing. Participants in the control group are on a waiting list and will start to exercise&#xD;
      after twelve weeks. Both groups undergo testing at baseline, after three, six and 12 months.&#xD;
      Testing consists of two parts: A battery of cognitive and psychosocial assessments and an&#xD;
      assessment of physical variables.&#xD;
&#xD;
      The research questions of this project are important in a public health perspective.&#xD;
      Generated knowledge can be quickly applied to local treatment institutions in Norway.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2018</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 31, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Height and weight</measure>
    <time_frame>12 weeks</time_frame>
    <description>Weight and height will be combined to report BMI in kg/m^2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endurance</measure>
    <time_frame>12 weeks</time_frame>
    <description>Ventilatory threshold/VO2max (endurance test on treadmill)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength</measure>
    <time_frame>12 weeks</time_frame>
    <description>Push-ups (maximal test where the participants perform a maximum number of correct push-ups)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Balance</measure>
    <time_frame>12 weeks</time_frame>
    <description>Stork Balance Test (timed test where the goal is to keep one's balance as long as possible)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alcohol use</measure>
    <time_frame>12 weeks</time_frame>
    <description>AUDIT-E</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug use</measure>
    <time_frame>12 weeks</time_frame>
    <description>DUDIT-E</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Executive functions</measure>
    <time_frame>12 weeks</time_frame>
    <description>Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with life</measure>
    <time_frame>12 weeks</time_frame>
    <description>Satisfaction With Life Scale (SWLS)&#xD;
Values/scores:&#xD;
7 - Strongly agree&#xD;
6 - Agree&#xD;
5 - Slightly agree&#xD;
4 - Neither agree nor disagree&#xD;
3 - Slightly disagree&#xD;
2 - Disagree&#xD;
1 - Strongly disagree&#xD;
Results (sum of scores/values):&#xD;
31 - 35 Extremely satisfied 26 - 30 Satisfied 21 - 25 Slightly satisfied 20 Neutral 15 - 19 Slightly dissatisfied 10 - 14 Dissatisfied 5 - 9 Extremely dissatisfied The higher the score the better the outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>12 weeks</time_frame>
    <description>Pittsburgh Sleep Quality Index (PSQI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attention</measure>
    <time_frame>12 weeks</time_frame>
    <description>Connors Continuous Performance Test (CPT 3)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Opioid-use Disorder</condition>
  <condition>Substance Use Disorders</condition>
  <condition>Opioid Dependence</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group is a waiting list group. The participants will receive exercise intervention after twelve weeks of treatment as usual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Exercise of choice with a training contact: 3 hrs/week, total of 12 weeks.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must sign a informed consent form&#xD;
&#xD;
          -  Must be participating in an opioid substitution program&#xD;
&#xD;
          -  Must be on a steady fixed dose of medication&#xD;
&#xD;
          -  Must be at least 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Being in opioid substitution program for less than three months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asgeir Mamen, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Kristiania University College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>October 25, 2018</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 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>Substance-Related Disorders</mesh_term>
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT04496934/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT04496934/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04496934
org study id: 2013/00731
nct id: NCT04496934
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
In terms of research, it is documented that exercise has a positive effect on mental
      disorders. Studies have shown positive correlations between physical and mental health, also
      among substance users. Such a study has never been performed on patients in opioid
      substitution therapy (OST). Documentation on the physical health of patients and the effect
      of exercise is very limited. Treatment of substance users is a research area with
      insufficient knowledge about certain treatment effects. It is important that a treatment can
      both support and promote the user's own resources and efforts to change their habits of
      substance use.

      The objective of this project is to examine the effect of exercise for OST patients, measured
      in relation to cognitive function and physical form. The target group consists of OST
      patients from 18 years of age and up, of both sexes, and on stable medication. At least 60
      participants should complete the project, which is designed as a controlled randomized study
      (RCT). Participants in the intervention group start to exercise immediately after baseline
      testing. Participants in the control group are on a waiting list and will start to exercise
      after twelve weeks. Both groups undergo testing at baseline, after three, six and 12 months.
      Testing consists of two parts: A battery of cognitive and psychosocial assessments and an
      assessment of physical variables.

      The research questions of this project are important in a public health perspective.
      Generated knowledge can be quickly applied to local treatment institutions in Norway.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Height and weight
time frame: 12 weeks
description: Weight and height will be combined to report BMI in kg/m^2
measure: Endurance
time frame: 12 weeks
description: Ventilatory threshold/VO2max (endurance test on treadmill)
measure: Strength
time frame: 12 weeks
description: Push-ups (maximal test where the participants perform a maximum number of correct push-ups)
measure: Balance
time frame: 12 weeks
description: Stork Balance Test (timed test where the goal is to keep one's balance as long as possible)
measure: Alcohol use
time frame: 12 weeks
description: AUDIT-E
measure: Drug use
time frame: 12 weeks
description: DUDIT-E
measure: Executive functions
time frame: 12 weeks
description: Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
measure: Satisfaction with life
time frame: 12 weeks
description: Satisfaction With Life Scale (SWLS)
Values/scores:
7 - Strongly agree
6 - Agree
5 - Slightly agree
4 - Neither agree nor disagree
3 - Slightly disagree
2 - Disagree
1 - Strongly disagree
Results (sum of scores/values):
31 - 35 Extremely satisfied 26 - 30 Satisfied 21 - 25 Slightly satisfied 20 Neutral 15 - 19 Slightly dissatisfied 10 - 14 Dissatisfied 5 - 9 Extremely dissatisfied The higher the score the better the outcome.
measure: Sleep quality
time frame: 12 weeks
description: Pittsburgh Sleep Quality Index (PSQI)
measure: Attention
time frame: 12 weeks
description: Connors Continuous Performance Test (CPT 3)
arm group label: Intervention
arm group type: Experimental
description: Exercise intervention
arm group label: Control
arm group type: Active Comparator
description: The control group is a waiting list group. The participants will receive exercise intervention after twelve weeks of treatment as usual.
intervention type: Behavioral
intervention name: Exercise
description: Exercise of choice with a training contact: 3 hrs/week, total of 12 weeks.
arm group label: Control
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Asgeir Mamen, PhD
role: Study Director
affiliation: Kristiania University College
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Substance-Related Disorders
mesh term: Opioid-Related Disorders
sharing ipd: No
provided document: 
provided document: 