<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/NCT04400630</url>
  </required_header>
  <id_info>
    <org_study_id>FINEX-BD</org_study_id>
    <nct_id>NCT04400630</nct_id>
  </id_info>
  <brief_title>Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-exercise Program (FINEXT-BD Study)</brief_title>
  <acronym>FINEXT-BD</acronym>
  <official_title>Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-exercise Program (FINEXT-BD Study): Protocol of a Randomized Interventionist Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bioaraba Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bioaraba Health Research Institute</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>
      This is a study that aimed to deep in the physiopathology of BD and see how, through&#xD;
      potential modifiable areas of the patients' lifestyle, the prognosis and evolution of the&#xD;
      pathology can be improved.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized interventionist study (ratio 1:1) with two parallel branches, blinded by&#xD;
      evaluators (the evaluator does not know the branch of treatment to which the patient belongs&#xD;
      )to evaluate if an individualized moderate-to-vigorous physical exercise intensity program as&#xD;
      adjuvant therapy to standard drug therapy will improve the functional and neuropsychological&#xD;
      status of patients with Bipolar Disorder. The effectiveness of the intervention will be&#xD;
      assessed by an extensive battery of clinical tests, physical parameters (e.g. brain structure&#xD;
      changes measured by optical coherence tomography) and biological parameters (inflammation,&#xD;
      oxidative stress and neurotrophic factors).&#xD;
&#xD;
      The total sample of the study will be 80 patients and a sample of 40 controls (individuals&#xD;
      without psychiatric pathology). The sample of patients will be divided into 40 patients in&#xD;
      each group at random. In the intervention group, a supervised physical exercise treatment by&#xD;
      high-intensity interval training (HIT) will be performed during 16 weeks with 2 sessions per&#xD;
      week (32 sessions in total).Three visits will be made in both groups: baseline visit at the&#xD;
      beginning of the study, at 4 months (at the end of the intervention) and at 10 months (6&#xD;
      months after the end of the intervention)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 5, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Longitudinal, interventional, randomized, controlled, simple-blind clinical trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>The person in charge of the assessments will not be involved in the treatment program and will be blinded to this process. Study evaluators will be blinded to the treatment branch</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Functionality measured through the scale FAST (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>The Functioning Assessment Short Test is a brief instrument designed to assess functional impairment in severe mental disorders. The 24 items of the scale cover six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, and leisure time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Functionality measured through the scale FAST (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>The Functioning Assessment Short Test is a brief instrument designed to assess functional impairment in severe mental disorders. The 24 items of the scale cover six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, and leisure time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Functionality measured through the scale GAF (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Global Assessment of Functioning (GAF):This scale evaluates with a score from 0 to 100 the level of functioning and the severity of the patient's symptoms, the higher values corresponding to better overall functionality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Functionality measured through the scale GAF (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Global Assessment of Functioning (GAF):This scale evaluates with a score from 0 to 100 the level of functioning and the severity of the patient's symptoms, the higher values corresponding to better overall functionality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Functionality measured through the Strauss-Carpenter scale (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Strauss-Carpenter scale consists of four items rated from 0 to 4 on a Likert-type scale and yields a total score that is calculated by the addition of all item scores: the higher the score, the better is the prognosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Functionality measured through the Strauss-Carpenter scale (10) months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Strauss-Carpenter scale consists of four items rated from 0 to 4 on a Likert-type scale and yields a total score that is calculated by the addition of all item scores: the higher the score, the better is the prognosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TrkB-FL (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Expression of BDNF: TrkB-FL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TrkB-FL (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Expression of BDNF: TrkB-FL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TrkB-T (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Expression of BDNF:TrkB-T</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TrkB-T (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Expression of BDNF:TrkB-T</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BDNF (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Peripheral BDNF levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BDNF (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Peripheral BDNF levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of depressive symptoms (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Hamilton Depression Scale (HDRS-21)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of depressive symptoms (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Hamilton Depression Scale (HDRS-21)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VO2Peak in CPET (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Value of VO2Peak (L min-1) in cardiopulmonary exercise test (CPET)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VO2Peak in CPET (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Value of VO2Peak (L min-1) in cardiopulmonary exercise test (CPET)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative VO2Peak in CPET (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Value of relative VO2Peak (mL kg-1 min-1) in cardiopulmonary exercise test (CPET)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative VO2Peak in CPET (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Value of relative VO2Peak (mL kg-1 min-1) in cardiopulmonary exercise test (CPET)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>METs in CPET (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Value of metabolic equivalents in cardiopulmonary exercise test (CPET)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>METs in CPET (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Value of metabolic equivalents in cardiopulmonary exercise test (CPET)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VT1 and VT2 in CPET (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Value of first and second ventilatory threshold (VT1 and VT2)(mL kg-1 min-1) metabolic equivalents in cardiopulmonary exercise test (CPET)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VT1 and VT2 in CPET(10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Value of first and second ventilatory threshold (VT1 and VT2)(mL kg-1 min-1) metabolic equivalents in cardiopulmonary exercise test (CPET)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRpeak in CPET (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Value of HRpeak in cardiopulmonary exercise test (CPET)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRpeak in CPET (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Value of HRpeak in cardiopulmonary exercise test (CPET)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OCT Study of the retina by optical tomography (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>RFNL, GCL and IPL thickness in the two eyes, with each layer divided into segments: overall, temporal, nasal, superior and inferior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OCT Study of the retina by optical (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>RFNL, GCL and IPL thickness in the two eyes, with each layer divided into segments: overall, temporal, nasal, superior and inferior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle mass (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Anthropometric measures muscle mass (g)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle mass (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Anthropometric measures muscle mass (g)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat mass (%)(4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Anthropometric measures Fat mass (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat mass (%) (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Anthropometric measures Fat mass (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone mineral content (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Anthropometric measures: Bone mineral density (g/cm^2) shall be determined by Dual Energy X-Ray Absorptiometry (DXA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone mineral content (4 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Anthropometric measures: Bone mineral density (g/cm^2) shall be determined by Dual Energy X-Ray Absorptiometry (DXA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appendicular muscle mass (4months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Anthropometric measures: appendicular muscle mass (g) will also be determined by adding up the muscle mass of both arms and legs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appendicular muscle mass (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Anthropometric measures: appendicular muscle mass (g) will also be determined by adding up the muscle mass of both arms and legs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative stress (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Oxidative stress: Total Antioxidant Status (TAS), Glutathione peroxidase (GPx) y - Glutathione (GSH), Lipid Peroxidation (TBARS) y Nitrite (NO2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative stress (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Oxidative stress: Total Antioxidant Status (TAS), Glutathione peroxidase (GPx) y - Glutathione (GSH), Lipid Peroxidation (TBARS) y Nitrite (NO2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Cytokine levels: IL6 and prostaglandin Levels PGE2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Cytokine levels: IL6 and prostaglandin Levels PGE2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manic symptoms using the (YMRS) (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Young Mania Rating Scale (YMRS): The total score ranges from 0-60, with the status of euthymia being classified as getting 6 or fewer points, hypomania as getting 12 or more points, and mania as getting between 20 and 60 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manic symptoms using the (YMRS) (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Young Mania Rating Scale (YMRS): The total score ranges from 0-60, with the status of euthymia being classified as getting 6 or fewer points, hypomania as getting 12 or more points, and mania as getting between 20 and 60 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Physical parameters: Body mass (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Physical parameters: Body mass (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Physical parameters: Height (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Physical parameters: Height (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Physical parameters: Body mass index (kg/m2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Physical parameters: Body mass index (kg/m2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Physical parameters: Waist circumference (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference (4 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Physical parameters: Waist circumference (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SBP and DBP (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Physical parameters: Systolic and diastolic blood pressure (mm Hg) measured taken from the right arm in a seated and relaxed position by using a life-support monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SBP and DBP (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Physical parameters: Systolic and diastolic blood pressure (mm Hg) measured taken from the right arm in a seated and relaxed position by using a life-support monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TG (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Physical parameters: Serum levels of triglycerides (mg/dl )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TG (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Physical parameters: Serum levels of triglycerides (mg/dl )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Physical parameters: Glucose (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Physical parameters: Glucose (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Physical parameters: HDL colesterol (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Physical parameters: HDL colesterol (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient symptom severity measured through the scale CGI (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>The Clinical Global Impression Scale (CGI): consists of two subscales. Each subscale has a single item scored between 0, not evaluated, to 7 which corresponds to the maximum severity (severity subscale) or to a state of no improvement and aggravated worsening of the symptomatology (improvement subscale).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient symptom severity measured through the scale CGI (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>The Clinical Global Impression Scale (CGI): consists of two subscales. Each subscale has a single item scored between 0, not evaluated, to 7 which corresponds to the maximum severity (severity subscale) or to a state of no improvement and aggravated worsening of the symptomatology (improvement subscale).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive functioning measured through CVLT (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>California Verbal Learning Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive functioning measured through CVLT (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>California Verbal Learning Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive functioning measured through WSCT (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>Computerized version of Wisconsin Card Sorting Test: This test consists of cards depicting simple geometric figures that vary in color, shape, and number. Examinees must sort cards in accordance with one of three viable rules, i.e., according to the color, shape, or number of the depicted objects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive functioning measured through WSCT (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>Computerized version of Wisconsin Card Sorting Test: This test consists of cards depicting simple geometric figures that vary in color, shape, and number. Examinees must sort cards in accordance with one of three viable rules, i.e., according to the color, shape, or number of the depicted objects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive functioning measured through (SCWT) (10 months)</measure>
    <time_frame>Changes after 10 months</time_frame>
    <description>The Stroop Color and Word Test: Individuals are required to read three different tables as fast as possible. Two of them represent the &quot;congruous condition&quot; in which participants are required to read names of colors (color-words) printed in black ink (W) and name different color patches (C). Conversely, in the third table, named color-word (CW) condition, color-words are printed in an inconsistent color ink.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive functioning measured through (SCWT) (4 months)</measure>
    <time_frame>Change at the end of the training period (4 months)</time_frame>
    <description>The Stroop Color and Word Test: Individuals are required to read three different tables as fast as possible. Two of them represent the &quot;congruous condition&quot; in which participants are required to read names of colors (color-words) printed in black ink (W) and name different color patches (C). Conversely, in the third table, named color-word (CW) condition, color-words are printed in an inconsistent color ink.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>Control (TAU)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>patients without any intervention + treatment as usual (TAU)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PE intervention+TAU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physical exercise (PE) intervention + treatment as usual (TAU)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical exercise</intervention_name>
    <description>The experimental group will receive supervised physical exercise treatment by high-intensity interval training (HIT), alternating high and moderate intensities (20 min). The participants will exercise two non-consecutive days per week for 16 weeks under supervision by exercise specialists.</description>
    <arm_group_label>PE intervention+TAU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with bipolar disorder type I according to the criteria of the DSM-5&#xD;
             manual, diagnosis made by structured interview SCID-P.&#xD;
&#xD;
          -  The study includes patients with first episode and multiple episodes. At the beginning&#xD;
             of the study they must be in euthymia, that is, there will be no current diagnosis of&#xD;
             manic, hypomanic or depressive episode. Relapses during follow-up and the presence of&#xD;
             subindromial symptoms at any time will not result in exclusion from the study.&#xD;
&#xD;
          -  Patients may be treated with any treatment according to clinical guidelines.&#xD;
&#xD;
          -  Age: 18-65 years&#xD;
&#xD;
          -  Speak Spanish correctly&#xD;
&#xD;
          -  Informed consent for the study of the patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of organic diseases of the central nervous system (CNS) or history of head&#xD;
             trauma with loss of consciousness&#xD;
&#xD;
          -  Intellectual disability.&#xD;
&#xD;
          -  Acute inflammatory disease&#xD;
&#xD;
          -  Treatment with anti-inflammatory drugs during the week prior to sample taking&#xD;
&#xD;
          -  Pervasive developmental disorders.&#xD;
&#xD;
          -  Pregnancy and lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ana María Gonzalez-Pinto</last_name>
    <role>Principal Investigator</role>
    <affiliation>BIOARABA HRI</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ana María Gonzalez-Pinto</last_name>
    <phone>+34 945007879</phone>
    <email>anapinto@telefonica.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Araba University Hospital</name>
      <address>
        <city>Vitoria</city>
        <state>Alava</state>
        <zip>01009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ana María Gonzalez-Pinto</last_name>
      <phone>+34 945007879</phone>
      <email>anapinto@telefonica.net</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>September 14, 2020</last_update_submitted>
  <last_update_submitted_qc>September 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bioaraba Health Research Institute</investigator_affiliation>
    <investigator_full_name>ANA GONZALEZ PINTO</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bipolar Disorder</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/NCT04400630
org study id: FINEX-BD
nct id: NCT04400630
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a study that aimed to deep in the physiopathology of BD and see how, through
      potential modifiable areas of the patients' lifestyle, the prognosis and evolution of the
      pathology can be improved.
Randomized interventionist study (ratio 1:1) with two parallel branches, blinded by
      evaluators (the evaluator does not know the branch of treatment to which the patient belongs
      )to evaluate if an individualized moderate-to-vigorous physical exercise intensity program as
      adjuvant therapy to standard drug therapy will improve the functional and neuropsychological
      status of patients with Bipolar Disorder. The effectiveness of the intervention will be
      assessed by an extensive battery of clinical tests, physical parameters (e.g. brain structure
      changes measured by optical coherence tomography) and biological parameters (inflammation,
      oxidative stress and neurotrophic factors).

      The total sample of the study will be 80 patients and a sample of 40 controls (individuals
      without psychiatric pathology). The sample of patients will be divided into 40 patients in
      each group at random. In the intervention group, a supervised physical exercise treatment by
      high-intensity interval training (HIT) will be performed during 16 weeks with 2 sessions per
      week (32 sessions in total).Three visits will be made in both groups: baseline visit at the
      beginning of the study, at 4 months (at the end of the intervention) and at 10 months (6
      months after the end of the intervention)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Longitudinal, interventional, randomized, controlled, simple-blind clinical trial
primary purpose: Supportive Care
masking: Single (Investigator)
masking description: The person in charge of the assessments will not be involved in the treatment program and will be blinded to this process. Study evaluators will be blinded to the treatment branch
measure: Patient Functionality measured through the scale FAST (4 months)
time frame: Change at the end of the training period (4 months)
description: The Functioning Assessment Short Test is a brief instrument designed to assess functional impairment in severe mental disorders. The 24 items of the scale cover six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, and leisure time.
measure: Patient Functionality measured through the scale FAST (10 months)
time frame: Changes after 10 months
description: The Functioning Assessment Short Test is a brief instrument designed to assess functional impairment in severe mental disorders. The 24 items of the scale cover six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, and leisure time.
measure: Patient Functionality measured through the scale GAF (4 months)
time frame: Change at the end of the training period (4 months)
description: Global Assessment of Functioning (GAF):This scale evaluates with a score from 0 to 100 the level of functioning and the severity of the patient's symptoms, the higher values corresponding to better overall functionality.
measure: Patient Functionality measured through the scale GAF (10 months)
time frame: Changes after 10 months
description: Global Assessment of Functioning (GAF):This scale evaluates with a score from 0 to 100 the level of functioning and the severity of the patient's symptoms, the higher values corresponding to better overall functionality.
measure: Patient Functionality measured through the Strauss-Carpenter scale (4 months)
time frame: Change at the end of the training period (4 months)
description: Strauss-Carpenter scale consists of four items rated from 0 to 4 on a Likert-type scale and yields a total score that is calculated by the addition of all item scores: the higher the score, the better is the prognosis.
measure: Patient Functionality measured through the Strauss-Carpenter scale (10) months)
time frame: Changes after 10 months
description: Strauss-Carpenter scale consists of four items rated from 0 to 4 on a Likert-type scale and yields a total score that is calculated by the addition of all item scores: the higher the score, the better is the prognosis.
measure: TrkB-FL (4 months)
time frame: Change at the end of the training period (4 months)
description: Expression of BDNF: TrkB-FL
measure: TrkB-FL (10 months)
time frame: Changes after 10 months
description: Expression of BDNF: TrkB-FL
measure: TrkB-T (4 months)
time frame: Change at the end of the training period (4 months)
description: Expression of BDNF:TrkB-T
measure: TrkB-T (10 months)
time frame: Changes after 10 months
description: Expression of BDNF:TrkB-T
measure: BDNF (4 months)
time frame: Change at the end of the training period (4 months)
description: Peripheral BDNF levels
measure: BDNF (10 months)
time frame: Changes after 10 months
description: Peripheral BDNF levels
measure: Presence of depressive symptoms (4 months)
time frame: Change at the end of the training period (4 months)
description: Hamilton Depression Scale (HDRS-21)
measure: Presence of depressive symptoms (10 months)
time frame: Changes after 10 months
description: Hamilton Depression Scale (HDRS-21)
measure: VO2Peak in CPET (4 months)
time frame: Change at the end of the training period (4 months)
description: Value of VO2Peak (L min-1) in cardiopulmonary exercise test (CPET)
measure: VO2Peak in CPET (10 months)
time frame: Changes after 10 months
description: Value of VO2Peak (L min-1) in cardiopulmonary exercise test (CPET)
measure: Relative VO2Peak in CPET (4 months)
time frame: Change at the end of the training period (4 months)
description: Value of relative VO2Peak (mL kg-1 min-1) in cardiopulmonary exercise test (CPET)
measure: Relative VO2Peak in CPET (10 months)
time frame: Changes after 10 months
description: Value of relative VO2Peak (mL kg-1 min-1) in cardiopulmonary exercise test (CPET)
measure: METs in CPET (4 months)
time frame: Change at the end of the training period (4 months)
description: Value of metabolic equivalents in cardiopulmonary exercise test (CPET)
measure: METs in CPET (10 months)
time frame: Changes after 10 months
description: Value of metabolic equivalents in cardiopulmonary exercise test (CPET)
measure: VT1 and VT2 in CPET (4 months)
time frame: Change at the end of the training period (4 months)
description: Value of first and second ventilatory threshold (VT1 and VT2)(mL kg-1 min-1) metabolic equivalents in cardiopulmonary exercise test (CPET)
measure: VT1 and VT2 in CPET(10 months)
time frame: Changes after 10 months
description: Value of first and second ventilatory threshold (VT1 and VT2)(mL kg-1 min-1) metabolic equivalents in cardiopulmonary exercise test (CPET)
measure: HRpeak in CPET (4 months)
time frame: Change at the end of the training period (4 months)
description: Value of HRpeak in cardiopulmonary exercise test (CPET)
measure: HRpeak in CPET (10 months)
time frame: Changes after 10 months
description: Value of HRpeak in cardiopulmonary exercise test (CPET)
measure: OCT Study of the retina by optical tomography (4 months)
time frame: Change at the end of the training period (4 months)
description: RFNL, GCL and IPL thickness in the two eyes, with each layer divided into segments: overall, temporal, nasal, superior and inferior.
measure: OCT Study of the retina by optical (10 months)
time frame: Changes after 10 months
description: RFNL, GCL and IPL thickness in the two eyes, with each layer divided into segments: overall, temporal, nasal, superior and inferior.
measure: Muscle mass (4 months)
time frame: Change at the end of the training period (4 months)
description: Anthropometric measures muscle mass (g)
measure: Muscle mass (10 months)
time frame: Changes after 10 months
description: Anthropometric measures muscle mass (g)
measure: Fat mass (%)(4 months)
time frame: Change at the end of the training period (4 months)
description: Anthropometric measures Fat mass (%)
measure: Fat mass (%) (10 months)
time frame: Changes after 10 months
description: Anthropometric measures Fat mass (%)
measure: Bone mineral content (4 months)
time frame: Change at the end of the training period (4 months)
description: Anthropometric measures: Bone mineral density (g/cm^2) shall be determined by Dual Energy X-Ray Absorptiometry (DXA).
measure: Bone mineral content (4 months)
time frame: Changes after 10 months
description: Anthropometric measures: Bone mineral density (g/cm^2) shall be determined by Dual Energy X-Ray Absorptiometry (DXA).
measure: Appendicular muscle mass (4months)
time frame: Change at the end of the training period (4 months)
description: Anthropometric measures: appendicular muscle mass (g) will also be determined by adding up the muscle mass of both arms and legs.
measure: Appendicular muscle mass (10 months)
time frame: Changes after 10 months
description: Anthropometric measures: appendicular muscle mass (g) will also be determined by adding up the muscle mass of both arms and legs.
measure: Oxidative stress (4 months)
time frame: Change at the end of the training period (4 months)
description: Oxidative stress: Total Antioxidant Status (TAS), Glutathione peroxidase (GPx) y - Glutathione (GSH), Lipid Peroxidation (TBARS) y Nitrite (NO2)
measure: Oxidative stress (10 months)
time frame: Changes after 10 months
description: Oxidative stress: Total Antioxidant Status (TAS), Glutathione peroxidase (GPx) y - Glutathione (GSH), Lipid Peroxidation (TBARS) y Nitrite (NO2)
measure: Inflammation (4 months)
time frame: Change at the end of the training period (4 months)
description: Cytokine levels: IL6 and prostaglandin Levels PGE2
measure: Inflammation (10 months)
time frame: Changes after 10 months
description: Cytokine levels: IL6 and prostaglandin Levels PGE2
measure: Manic symptoms using the (YMRS) (4 months)
time frame: Change at the end of the training period (4 months)
description: Young Mania Rating Scale (YMRS): The total score ranges from 0-60, with the status of euthymia being classified as getting 6 or fewer points, hypomania as getting 12 or more points, and mania as getting between 20 and 60 points.
measure: Manic symptoms using the (YMRS) (10 months)
time frame: Changes after 10 months
description: Young Mania Rating Scale (YMRS): The total score ranges from 0-60, with the status of euthymia being classified as getting 6 or fewer points, hypomania as getting 12 or more points, and mania as getting between 20 and 60 points.
measure: Body mass (4 months)
time frame: Change at the end of the training period (4 months)
description: Physical parameters: Body mass (kg)
measure: Body mass (10 months)
time frame: Changes after 10 months
description: Physical parameters: Body mass (kg)
measure: Height (4 months)
time frame: Change at the end of the training period (4 months)
description: Physical parameters: Height (cm)
measure: Height (10 months)
time frame: Changes after 10 months
description: Physical parameters: Height (cm)
measure: BMI (4 months)
time frame: Change at the end of the training period (4 months)
description: Physical parameters: Body mass index (kg/m2)
measure: BMI (10 months)
time frame: Changes after 10 months
description: Physical parameters: Body mass index (kg/m2)
measure: Waist circumference (4 months)
time frame: Change at the end of the training period (4 months)
description: Physical parameters: Waist circumference (cm)
measure: Waist circumference (4 months)
time frame: Changes after 10 months
description: Physical parameters: Waist circumference (cm)
measure: SBP and DBP (4 months)
time frame: Change at the end of the training period (4 months)
description: Physical parameters: Systolic and diastolic blood pressure (mm Hg) measured taken from the right arm in a seated and relaxed position by using a life-support monitor
measure: SBP and DBP (10 months)
time frame: Changes after 10 months
description: Physical parameters: Systolic and diastolic blood pressure (mm Hg) measured taken from the right arm in a seated and relaxed position by using a life-support monitor
measure: TG (4 months)
time frame: Change at the end of the training period (4 months)
description: Physical parameters: Serum levels of triglycerides (mg/dl )
measure: TG (10 months)
time frame: Changes after 10 months
description: Physical parameters: Serum levels of triglycerides (mg/dl )
measure: Glucose (4 months)
time frame: Change at the end of the training period (4 months)
description: Physical parameters: Glucose (mg/dl)
measure: Glucose (10 months)
time frame: Changes after 10 months
description: Physical parameters: Glucose (mg/dl)
measure: HDL (4 months)
time frame: Change at the end of the training period (4 months)
description: Physical parameters: HDL colesterol (mg/dl)
measure: HDL (10 months)
time frame: Changes after 10 months
description: Physical parameters: HDL colesterol (mg/dl)
measure: Patient symptom severity measured through the scale CGI (4 months)
time frame: Change at the end of the training period (4 months)
description: The Clinical Global Impression Scale (CGI): consists of two subscales. Each subscale has a single item scored between 0, not evaluated, to 7 which corresponds to the maximum severity (severity subscale) or to a state of no improvement and aggravated worsening of the symptomatology (improvement subscale).
measure: Patient symptom severity measured through the scale CGI (10 months)
time frame: Changes after 10 months
description: The Clinical Global Impression Scale (CGI): consists of two subscales. Each subscale has a single item scored between 0, not evaluated, to 7 which corresponds to the maximum severity (severity subscale) or to a state of no improvement and aggravated worsening of the symptomatology (improvement subscale).
measure: Cognitive functioning measured through CVLT (10 months)
time frame: Changes after 10 months
description: California Verbal Learning Test
measure: Cognitive functioning measured through CVLT (4 months)
time frame: Change at the end of the training period (4 months)
description: California Verbal Learning Test
measure: Cognitive functioning measured through WSCT (10 months)
time frame: Changes after 10 months
description: Computerized version of Wisconsin Card Sorting Test: This test consists of cards depicting simple geometric figures that vary in color, shape, and number. Examinees must sort cards in accordance with one of three viable rules, i.e., according to the color, shape, or number of the depicted objects
measure: Cognitive functioning measured through WSCT (4 months)
time frame: Change at the end of the training period (4 months)
description: Computerized version of Wisconsin Card Sorting Test: This test consists of cards depicting simple geometric figures that vary in color, shape, and number. Examinees must sort cards in accordance with one of three viable rules, i.e., according to the color, shape, or number of the depicted objects
measure: Cognitive functioning measured through (SCWT) (10 months)
time frame: Changes after 10 months
description: The Stroop Color and Word Test: Individuals are required to read three different tables as fast as possible. Two of them represent the "congruous condition" in which participants are required to read names of colors (color-words) printed in black ink (W) and name different color patches (C). Conversely, in the third table, named color-word (CW) condition, color-words are printed in an inconsistent color ink.
measure: Cognitive functioning measured through (SCWT) (4 months)
time frame: Change at the end of the training period (4 months)
description: The Stroop Color and Word Test: Individuals are required to read three different tables as fast as possible. Two of them represent the "congruous condition" in which participants are required to read names of colors (color-words) printed in black ink (W) and name different color patches (C). Conversely, in the third table, named color-word (CW) condition, color-words are printed in an inconsistent color ink.
arm group label: Control (TAU)
arm group type: No Intervention
description: patients without any intervention + treatment as usual (TAU)
arm group label: PE intervention+TAU
arm group type: Experimental
description: Physical exercise (PE) intervention + treatment as usual (TAU)
intervention type: Other
intervention name: Physical exercise
description: The experimental group will receive supervised physical exercise treatment by high-intensity interval training (HIT), alternating high and moderate intensities (20 min). The participants will exercise two non-consecutive days per week for 16 weeks under supervision by exercise specialists.
arm group label: PE intervention+TAU
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ana María Gonzalez-Pinto
role: Principal Investigator
affiliation: BIOARABA HRI
last name: Ana María Gonzalez-Pinto
phone: +34 945007879
email: anapinto@telefonica.net
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Bioaraba Health Research Institute
investigator full name: ANA GONZALEZ PINTO
investigator title: Principal Investigator
mesh term: Bipolar Disorder