<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/NCT02205684</url>
  </required_header>
  <id_info>
    <org_study_id>2014/372/REK sør-øst C</org_study_id>
    <nct_id>NCT02205684</nct_id>
  </id_info>
  <brief_title>Effects of Physical Activity in Psychosis</brief_title>
  <acronym>EPHAPS</acronym>
  <official_title>Effects of Aerobic High Intensity Training on Symptoms, Cognition, Cortical Structure, Substance Use and Metabolic Indices in Patients With Schizophrenia Spectrum Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sykehuset i Vestfold HF</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stiftelsen Helse og Rehabilitering</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian Research network in Severe Mental Illness</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sykehuset i Vestfold HF</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Physical health problems are common in schizophrenia with a two- to three-fold increased&#xD;
      morbidity and mortality rate, resulting in a 20 years reduction in life expectancy. A genetic&#xD;
      vulnerability for developing cardiovascular disease has been documented in these patients,&#xD;
      and many lifestyle factors also negatively influence physical health. Patients with&#xD;
      schizophrenia are likely to smoke, are physically inactive and overweight, suffer from&#xD;
      malnutrition due to unhealthy diet, and have reduced cardiorespiratory fitness. Moreover,&#xD;
      these patients have increased risk of developing diabetes mellitus type II and metabolic&#xD;
      syndrome. These aspects demonstrate the need for multi-disciplinary treatments of patients&#xD;
      with schizophrenia and underline the need for addressing their physical health.&#xD;
&#xD;
      Poor physical fitness seems to be associated with exacerbated negative symptoms and increased&#xD;
      cognitive dysfunction in patients with schizophrenia. However, evidence on physical activity&#xD;
      and its consequences in schizophrenia is scarce. In this randomized controlled trial we&#xD;
      investigate the effects of high intensity training in outpatients with schizophrenia on&#xD;
      psychotic symptoms and well-being, cognition and cortical structure, tobacco smoking and&#xD;
      substance use, in addition to metabolic indices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Outpatients in treatment will be recruited in this randomized controlled trial (RCT). The&#xD;
      patients will be randomized to either a Computer gaming Skills Group (CSG) or to a physical&#xD;
      Exercise Group (EG). The groups are identically organized in two locations. The interventions&#xD;
      last for 12 weeks, and treatment as usual will be continued for all patients. Patients will&#xD;
      be assessed when entering the study (after randomization and allocation to one of the&#xD;
      clinical groups), as well as post-treatment and 4 months post-treatment. Thus, the planned&#xD;
      study is prospective with a longitudinal design. It is single blind in the sense that the&#xD;
      assessment of psychiatric symptom level and neurocognitive function will be performed by&#xD;
      research staff blind for group membership. The physiological testing will be performed by&#xD;
      staff involved in training and will not be blinded.&#xD;
&#xD;
      EG participants will perform aerobic high intensity training (HIT) consisting of supervised&#xD;
      walking/running on a treadmill 2 times a week for 12 weeks. Each session will have the&#xD;
      following structure; eight-minute warm-up, followed by four times four minutes intervals with&#xD;
      85-95% of maximum heart rate, with active pauses of three minutes of walking at 70% of&#xD;
      maximum heart rate. The exercise session will end with a five minute cool-down period. HIT&#xD;
      performed as 4 x 4 intervals has been proven feasible and safe among patients with&#xD;
      schizophrenia and in other clinical populations.&#xD;
&#xD;
      Participants in the CSG take part in sessions in the clinic playing computer games (Nintendo&#xD;
      Wii Sports). The time spent with activities in the clinic will be the same in both groups.&#xD;
      When absent from scheduled physical exercise/playing computer games the subjects will be&#xD;
      offered to participate on a following day. If absent for a whole week, the training&#xD;
      period/computer games playing period will be prolonged accordingly.&#xD;
&#xD;
      In this randomized controlled trial we investigate the effects of HIT in outpatients with&#xD;
      schizophrenia on symptoms and well-being, cognition and brain structure, smoking habits and&#xD;
      substance use, as well as metabolic indices.&#xD;
&#xD;
      The participating outpatient clinics are catchment area based and cover a population of 200&#xD;
      000 persons with more than 250 patients in the diagnostic group in treatment at one time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Actual">October 2017</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Cognitive Function after 12 Weeks and 28 Weeks</measure>
    <time_frame>Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Symptom load after 12 Weeks and 28 Weeks</measure>
    <time_frame>Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Peak oxygen uptake after 12 Weeks and 28 Weeks</measure>
    <time_frame>Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Metabolic Indices after 12 Weeks and 28 Weeks</measure>
    <time_frame>Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">126</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Substance Use</condition>
  <arm_group>
    <arm_group_label>Physical activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aerobic High Intensity Training (HIT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Computer game skills training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Playing Nintendo Wii Sports</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Computer game skills training</intervention_name>
    <description>Playing Nintendo Wii Sports</description>
    <arm_group_label>Computer game skills training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical activity</intervention_name>
    <description>Aerobic High Intensity Training (HIT)</description>
    <arm_group_label>Physical activity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  verified (Structured Clinical Interview for the Diagnostic and Statistical Manual of&#xD;
             Mental Disorders, SCID) diagnosis of schizophrenia spectrum disorder&#xD;
&#xD;
          -  outpatient in treatment&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  fluent in a Scandinavian language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chest pain during exercise&#xD;
&#xD;
          -  unstable angina pectoris&#xD;
&#xD;
          -  suspicion of recent myocardial infarction&#xD;
&#xD;
          -  uncontrollable arrhythmia&#xD;
&#xD;
          -  acute infection with lymphadenopathy&#xD;
&#xD;
          -  malignant hypertension&#xD;
&#xD;
          -  neurological disorder&#xD;
&#xD;
          -  severe physical disability&#xD;
&#xD;
          -  medical condition incompatible with particiption&#xD;
&#xD;
          -  comorbid diagnosis of mild mental retardation&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John A Engh, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Mental Health &amp; Addiction, Vestfold Hospital Trust, Tønsberg, Norway</affiliation>
  </overall_official>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>April 16, 2018</last_update_submitted>
  <last_update_submitted_qc>April 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sykehuset i Vestfold HF</investigator_affiliation>
    <investigator_full_name>John Abel Engh</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>Exercise</keyword>
  <keyword>High intensity training</keyword>
  <keyword>Schizophrenia</keyword>
  <keyword>Symptoms</keyword>
  <keyword>Well-being</keyword>
  <keyword>Cognition</keyword>
  <keyword>Hippocampal volume</keyword>
  <keyword>Neuroplasticity</keyword>
  <keyword>Smoking</keyword>
  <keyword>Substance use</keyword>
  <keyword>Metabolic indices</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Schizophrenia</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/NCT02205684
org study id: 2014/372/REK sør-øst C
nct id: NCT02205684
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Physical health problems are common in schizophrenia with a two- to three-fold increased
      morbidity and mortality rate, resulting in a 20 years reduction in life expectancy. A genetic
      vulnerability for developing cardiovascular disease has been documented in these patients,
      and many lifestyle factors also negatively influence physical health. Patients with
      schizophrenia are likely to smoke, are physically inactive and overweight, suffer from
      malnutrition due to unhealthy diet, and have reduced cardiorespiratory fitness. Moreover,
      these patients have increased risk of developing diabetes mellitus type II and metabolic
      syndrome. These aspects demonstrate the need for multi-disciplinary treatments of patients
      with schizophrenia and underline the need for addressing their physical health.

      Poor physical fitness seems to be associated with exacerbated negative symptoms and increased
      cognitive dysfunction in patients with schizophrenia. However, evidence on physical activity
      and its consequences in schizophrenia is scarce. In this randomized controlled trial we
      investigate the effects of high intensity training in outpatients with schizophrenia on
      psychotic symptoms and well-being, cognition and cortical structure, tobacco smoking and
      substance use, in addition to metabolic indices.
Outpatients in treatment will be recruited in this randomized controlled trial (RCT). The
      patients will be randomized to either a Computer gaming Skills Group (CSG) or to a physical
      Exercise Group (EG). The groups are identically organized in two locations. The interventions
      last for 12 weeks, and treatment as usual will be continued for all patients. Patients will
      be assessed when entering the study (after randomization and allocation to one of the
      clinical groups), as well as post-treatment and 4 months post-treatment. Thus, the planned
      study is prospective with a longitudinal design. It is single blind in the sense that the
      assessment of psychiatric symptom level and neurocognitive function will be performed by
      research staff blind for group membership. The physiological testing will be performed by
      staff involved in training and will not be blinded.

      EG participants will perform aerobic high intensity training (HIT) consisting of supervised
      walking/running on a treadmill 2 times a week for 12 weeks. Each session will have the
      following structure; eight-minute warm-up, followed by four times four minutes intervals with
      85-95% of maximum heart rate, with active pauses of three minutes of walking at 70% of
      maximum heart rate. The exercise session will end with a five minute cool-down period. HIT
      performed as 4 x 4 intervals has been proven feasible and safe among patients with
      schizophrenia and in other clinical populations.

      Participants in the CSG take part in sessions in the clinic playing computer games (Nintendo
      Wii Sports). The time spent with activities in the clinic will be the same in both groups.
      When absent from scheduled physical exercise/playing computer games the subjects will be
      offered to participate on a following day. If absent for a whole week, the training
      period/computer games playing period will be prolonged accordingly.

      In this randomized controlled trial we investigate the effects of HIT in outpatients with
      schizophrenia on symptoms and well-being, cognition and brain structure, smoking habits and
      substance use, as well as metabolic indices.

      The participating outpatient clinics are catchment area based and cover a population of 200
      000 persons with more than 250 patients in the diagnostic group in treatment at one time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from Baseline in Cognitive Function after 12 Weeks and 28 Weeks
time frame: Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment
measure: Change from Baseline in Symptom load after 12 Weeks and 28 Weeks
time frame: Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment
measure: Change from Baseline in Peak oxygen uptake after 12 Weeks and 28 Weeks
time frame: Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment
measure: Change from Baseline in Metabolic Indices after 12 Weeks and 28 Weeks
time frame: Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment
arm group label: Physical activity
arm group type: Experimental
description: Aerobic High Intensity Training (HIT)
arm group label: Computer game skills training
arm group type: Active Comparator
description: Playing Nintendo Wii Sports
intervention type: Other
intervention name: Computer game skills training
description: Playing Nintendo Wii Sports
arm group label: Computer game skills training
intervention type: Other
intervention name: Physical activity
description: Aerobic High Intensity Training (HIT)
arm group label: Physical activity
criteria: 
gender: All
minimum age: 18 Years
maximum age: 67 Years
healthy volunteers: No
last name: John A Engh, MD, PhD
role: Principal Investigator
affiliation: Division of Mental Health & Addiction, Vestfold Hospital Trust, Tønsberg, Norway
responsible party type: Principal Investigator
investigator affiliation: Sykehuset i Vestfold HF
investigator full name: John Abel Engh
investigator title: Principal Investigator
mesh term: Substance-Related Disorders
mesh term: Schizophrenia