xml: <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/NCT05978921</url>
    </required_header>
    <id_info>
      <org_study_id>ExerciseSchizophrenia</org_study_id>
      <nct_id>NCT05978921</nct_id>
    </id_info>
    <brief_title>Physical Exercise in Patients With Schizophrenia</brief_title>
    <official_title>Effect of Physical Strength Exercise on Telomeric Length as a Marker of Aging and Early Death in Patients With Schizophrenia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Salamanca</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Salamanca</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>
        Randomised clinical trial on a cohort of subjects with a diagnosis of schizophrenia of legal&#xD;
        age, of both sexes, recruited in the mental health clinics of the Salamanca University&#xD;
        Assistance Complex and who will be randomly distributed into two groups (intervention and&#xD;
        control).&#xD;
  &#xD;
        The main objective of the study is to determine the effect of physical exercise on telomere&#xD;
        size in patients diagnosed with schizophrenia.&#xD;
  &#xD;
        As secondary objectives in this group of patients we will try to:&#xD;
  &#xD;
        Evaluate the influence of strength training on cognition and negative symptoms of&#xD;
        schizophrenia.&#xD;
  &#xD;
        To quantify the impact of strength training on frailty. To determine the effect of strength&#xD;
        training on quality of life. To study the possible correlation between physical parameters&#xD;
        (frailty) and telomere length.&#xD;
  &#xD;
        To establish the importance of polymorphisms in telomerase genes, an enzyme involved in the&#xD;
        maintenance of telomere length.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">May 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2024</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>Health Services Research</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The persons in charge of the evaluation of the participants will be unaware of the assignment of the participants.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Telomere Length</measure>
      <time_frame>Baseline and immediately after the intervention</time_frame>
      <description>Telomere length will be measured before and after the procedure in kilobases.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Date of birth</measure>
      <time_frame>Baseline</time_frame>
      <description>It will be registered at the beginning of the study in order to calculate the age of the participant.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sex</measure>
      <time_frame>Baseline</time_frame>
      <description>It will be registered at the beginning of the study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heighth</measure>
      <time_frame>Baseline</time_frame>
      <description>It will be registered at the beginning of the study in centimeters.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Negative Symptoms</measure>
      <time_frame>Baseline and immediately after the intervention</time_frame>
      <description>Negative symptoms of the disease will be measured and assessed using the Brief Negative Symptom Scale (BNSS). The BNSS is comprised of 13 questions organized into 6 subscales that assess anhedonia, distress, asociality, avolition, blunted affect, and alogia. Items are scored on a 0 to 6 scale, with 0 indicating the symptom is absent and 6 indicating the symptom is severe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fragility</measure>
      <time_frame>Baseline and immediately after the intervention</time_frame>
      <description>Fragility will be measured using the Short Physical Performance Battery scale (SPPB). SPPB scores range from zero to 12 possible points. SPPB score of 3-9 points in persons with possible sarcopenia but no mobility disability indicates frailty; SPPB score of 10 or greater for persons with no sarcopenia and no mobility disability indicates robustness. Persons with a score of 2 or lower who have sarcopenia, potential cachexia, and mobility disability are determined to be disabled.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognition</measure>
      <time_frame>Baseline and immediately after the intervention</time_frame>
      <description>Cognition will be measured using the Brief Assessment of Cognition in Schizophrenia (BACS).The maximum and minimum score on the Brief Assessment of Cognition in Schizophrenia (BACS) is 100 points and the minimum possible score is 0 points. The scoring scale is based on the performance of a normative reference group, where the mean is set at 100 and the standard deviation at 15. Thus, a score of 100 indicates average performance within the normative population, while a higher score would be considered above average and a lower score below average.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life</measure>
      <time_frame>Baseline and immediately after the intervention</time_frame>
      <description>Quality of life will be assessed using the EuroQuality of Life (EQ-5D-5L scale). This scale is numbered from 0 to 100. • 100 means the best health you can imagine. 0 means the worst health you can imagine.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Schizophrenia</condition>
    <condition>Physical Activity</condition>
    <condition>Telomere Shortening</condition>
    <condition>Premature Aging</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>An additional strength training programme will be carried out for 12 weeks with 2 sessions per week. The sessions will last approximately 50 minutes and will be divided into 3 distinct parts: The first part will consist of a warm-up with a part of aerobic exercise that will last approximately 15 minutes. This will be followed by the main part of strength training with a circuit of 6 exercises (3 series x 12 repetitions) which will last approximately 25 minutes.&#xD;
  Finally, there will be a cool down phase with breathing exercises to allow people to recover.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Subjects in the control group will continue with their normal life and carry out all the activities they have been doing previously.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Strength physical exercise programme</intervention_name>
      <description>12 multi-joint strength exercises will be developed. Participants will be taught the rating scale of perceived exertion (RPE) based on the number of repetitions in reserve (RIR). Participants will be asked that during the performance of each of the exercises they must perceive an effort between 7-8 within the overall score of the scale (0-10; 0 = no effort at all and 10 = cannot perform one more repetition, i.e. maximal effort). When subjects perform the 12 repetitions with lower perceived exertion than the set effort in two consecutive sessions with full range of motion the training load will be increased by about 2-10% following the American College of Sports Medicine guidelines and reassessed using the RIR-based RPE. Patients in the usual treatment group will continue to participate in their existing rehabilitation programmes, but will not be included in the strength training programme.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Normal life</intervention_name>
      <description>Normal life and carry out all the activities they have been doing previously.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  be at least 18 years of age&#xD;
  &#xD;
            -  have been diagnosed with schizophrenia for at least 5 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  are unable to read and understand the patient information sheet and sign the informed&#xD;
               consent form.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Juan Luis Sánchez González, Phd</last_name>
      <phone>660738949</phone>
      <email>juanluissanchez@usal.es</email>
    </overall_contact>
    <location>
      <facility>
        <name>Universidad de Salamanca</name>
        <address>
          <city>Salamanca</city>
          <state>Castilla Y León / Salamanca</state>
          <zip>37007</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Juan Luis Sánchez González, Phd</last_name>
        <phone>660738949</phone>
        <email>juanluissanchez@usal.es</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Salamanca</investigator_affiliation>
      <investigator_full_name>Juan Luis Sanchez Gonzalez</investigator_full_name>
      <investigator_title>Principal Investigator. Juan Luis Sánchez González</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aging, Premature</mesh_term>
      <mesh_term>Schizophrenia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Upon request by e-mail to the principal investigator</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05978921
  org study id: ExerciseSchizophrenia
  nct id: NCT05978921
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Randomised clinical trial on a cohort of subjects with a diagnosis of schizophrenia of legal
        age, of both sexes, recruited in the mental health clinics of the Salamanca University
        Assistance Complex and who will be randomly distributed into two groups (intervention and
        control).
  
        The main objective of the study is to determine the effect of physical exercise on telomere
        size in patients diagnosed with schizophrenia.
  
        As secondary objectives in this group of patients we will try to:
  
        Evaluate the influence of strength training on cognition and negative symptoms of
        schizophrenia.
  
        To quantify the impact of strength training on frailty. To determine the effect of strength
        training on quality of life. To study the possible correlation between physical parameters
        (frailty) and telomere length.
  
        To establish the importance of polymorphisms in telomerase genes, an enzyme involved in the
        maintenance of telomere length.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Single (Outcomes Assessor)
  masking description: The persons in charge of the evaluation of the participants will be unaware of the assignment of the participants.
  measure: Telomere Length
  time frame: Baseline and immediately after the intervention
  description: Telomere length will be measured before and after the procedure in kilobases.
  measure: Date of birth
  time frame: Baseline
  description: It will be registered at the beginning of the study in order to calculate the age of the participant.
  measure: Sex
  time frame: Baseline
  description: It will be registered at the beginning of the study.
  measure: Heighth
  time frame: Baseline
  description: It will be registered at the beginning of the study in centimeters.
  measure: Negative Symptoms
  time frame: Baseline and immediately after the intervention
  description: Negative symptoms of the disease will be measured and assessed using the Brief Negative Symptom Scale (BNSS). The BNSS is comprised of 13 questions organized into 6 subscales that assess anhedonia, distress, asociality, avolition, blunted affect, and alogia. Items are scored on a 0 to 6 scale, with 0 indicating the symptom is absent and 6 indicating the symptom is severe
  measure: Fragility
  time frame: Baseline and immediately after the intervention
  description: Fragility will be measured using the Short Physical Performance Battery scale (SPPB). SPPB scores range from zero to 12 possible points. SPPB score of 3-9 points in persons with possible sarcopenia but no mobility disability indicates frailty; SPPB score of 10 or greater for persons with no sarcopenia and no mobility disability indicates robustness. Persons with a score of 2 or lower who have sarcopenia, potential cachexia, and mobility disability are determined to be disabled.
  measure: Cognition
  time frame: Baseline and immediately after the intervention
  description: Cognition will be measured using the Brief Assessment of Cognition in Schizophrenia (BACS).The maximum and minimum score on the Brief Assessment of Cognition in Schizophrenia (BACS) is 100 points and the minimum possible score is 0 points. The scoring scale is based on the performance of a normative reference group, where the mean is set at 100 and the standard deviation at 15. Thus, a score of 100 indicates average performance within the normative population, while a higher score would be considered above average and a lower score below average.
  measure: Quality of life
  time frame: Baseline and immediately after the intervention
  description: Quality of life will be assessed using the EuroQuality of Life (EQ-5D-5L scale). This scale is numbered from 0 to 100. • 100 means the best health you can imagine. 0 means the worst health you can imagine.
  arm group label: Intervention group
  arm group type: Experimental
  description: An additional strength training programme will be carried out for 12 weeks with 2 sessions per week. The sessions will last approximately 50 minutes and will be divided into 3 distinct parts: The first part will consist of a warm-up with a part of aerobic exercise that will last approximately 15 minutes. This will be followed by the main part of strength training with a circuit of 6 exercises (3 series x 12 repetitions) which will last approximately 25 minutes.
  Finally, there will be a cool down phase with breathing exercises to allow people to recover.
  arm group label: Control group
  arm group type: Sham Comparator
  description: Subjects in the control group will continue with their normal life and carry out all the activities they have been doing previously.
  intervention type: Other
  intervention name: Strength physical exercise programme
  description: 12 multi-joint strength exercises will be developed. Participants will be taught the rating scale of perceived exertion (RPE) based on the number of repetitions in reserve (RIR). Participants will be asked that during the performance of each of the exercises they must perceive an effort between 7-8 within the overall score of the scale (0-10; 0 = no effort at all and 10 = cannot perform one more repetition, i.e. maximal effort). When subjects perform the 12 repetitions with lower perceived exertion than the set effort in two consecutive sessions with full range of motion the training load will be increased by about 2-10% following the American College of Sports Medicine guidelines and reassessed using the RIR-based RPE. Patients in the usual treatment group will continue to participate in their existing rehabilitation programmes, but will not be included in the strength training programme.
  arm group label: Intervention group
  intervention type: Other
  intervention name: Normal life
  description: Normal life and carry out all the activities they have been doing previously.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Juan Luis Sánchez González, Phd
  phone: 660738949
  email: juanluissanchez@usal.es
  facility: 
  contact: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: University of Salamanca
  investigator full name: Juan Luis Sanchez Gonzalez
  investigator title: Principal Investigator. Juan Luis Sánchez González
  mesh term: Aging, Premature
  mesh term: Schizophrenia
  sharing ipd: Undecided
  ipd description: Upon request by e-mail to the principal investigator