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/NCT05992649</url>
    </required_header>
    <id_info>
      <org_study_id>V24</org_study_id>
      <nct_id>NCT05992649</nct_id>
    </id_info>
    <brief_title>The Effect of Aquatic Physiotherapy on Veterans Suffering From PTSD - a 24-week Pilotproject</brief_title>
    <official_title>The Effect of Aquatic Physiotherapy on Veterans Suffering From PTSD - a 24-week Pilotproject</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>vandfys</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Herlev and Gentofte Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>vandfys</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Aquatic physiotherapy in warm water pool (AP) is thought to be a helpful treatment for&#xD;
        veterans suffering from post-traumatic stress disorder (PTSD). A 24-week program can provide&#xD;
        an opportunity to achieve positive results.&#xD;
  &#xD;
        Potentiel effects of AP for veterans with PTSD:&#xD;
  &#xD;
        Relaxation and stress reduction, anxiety and mood regulation, body awareness and grounding,&#xD;
        strength and flexibility and social interactions and camaraderie.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It is estimated that 5% of all veterans who have been deployed have PTSD. In Denmark the&#xD;
        total number of deployments are about 27.000 from 1992 - 2012.&#xD;
  &#xD;
        The purpose of the project is to investigate the effect of aquatic physiotherapy treatment&#xD;
        and physical training in 34-35 degree centigrade warm water in a 24-week program consisting&#xD;
        of:&#xD;
  &#xD;
          1. st 8 weeks: 30 minutes treatment once a week.&#xD;
  &#xD;
          2. nd 8 weeks: 30 minutes treatment once a week +&#xD;
  &#xD;
        60 minutes of combined training and relaxation once a week.&#xD;
  &#xD;
        3rd 8 weeks: 60 minutes of combined training and relaxation once a week + an activity of own&#xD;
        choice once a week.&#xD;
  &#xD;
        Hypothesis:&#xD;
  &#xD;
        Veterans with PTSD will experience a reduction in levels of PTSD symptoms.&#xD;
  &#xD;
        Methodical approach:&#xD;
  &#xD;
        Design: pilot project with an intervention group of 12 receiving treatment and physical&#xD;
        training.&#xD;
  &#xD;
        Recruitment:&#xD;
  &#xD;
        The participants are recruited from Copenhagen Veteran Home, Høvelte Barracks Veteran Home&#xD;
        and Military Psychiatric Outpatient Clinic, Rigshospitalet.&#xD;
  &#xD;
        cf. inclusion and exclusion criteria.&#xD;
  &#xD;
        No of participants to be recruited: 12&#xD;
  &#xD;
        Primary effect measures:&#xD;
  &#xD;
        Change of PTSD level from baseline using validated questionnaire PCL-M&#xD;
  &#xD;
        Secondary effect measures:&#xD;
  &#xD;
          1. Change of sleep disorders from baseline using validated questionnaire Pittsburgh Sleep&#xD;
             Quality Index (PSQI).&#xD;
  &#xD;
          2. Change of self-perceived levels of depression and anxiety by questionnaire (Hopkins&#xD;
             symptoms checklist)&#xD;
  &#xD;
          3. Change in self-perceived quality of wellbeing measured by questionnaire (WHO-5)&#xD;
             Measurements to be taken before and after 24-weeks intervention&#xD;
  &#xD;
        Explorative measures:&#xD;
  &#xD;
        Change in functionality/ability with everyday life measured by questionnaire (The&#xD;
        questionnaire method for assessing functionality/ability&#xD;
  &#xD;
        Ethical considerations:&#xD;
  &#xD;
        Participation in warm water treatment is considered without side effects or risks.&#xD;
  &#xD;
        Using exercise in warm water is part of general physiotherapeutic practice. The treatment is&#xD;
        handled by experienced physiotherapists. The project complies with the Helsinki Declaration.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 23, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 23, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Single group study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Level of symptoms of PTSD</measure>
      <time_frame>24-weeks</time_frame>
      <description>Measured by self reported questionnaire PTSD Checklist for military (PCL-M). The self-report rating scale is 0-4 for each symptom (0 = Not at all, 1 = A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely).&#xD;
  A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items. A score between 17-29 suggests little to no severity. A score between 28-29 suggests some PTSD symptoms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quality of sleep</measure>
      <time_frame>24-weeks</time_frame>
      <description>Measured by self reported questionnaire Pittsburgh Sleep Quality Index (PSQI). In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Levels of symptoms of depression and anxiety</measure>
      <time_frame>24-weeks</time_frame>
      <description>Measured by self reported questionnaire Hopkins symptoms checklist. The scale for each question includes four categories of response (&quot;Not at all,&quot; &quot;A little,&quot; &quot;Quite a bit,&quot; &quot;Extremely,&quot; rated 1 to 4, respectively). Two scores are calculated: the total score is the average of all 25 items, while the depression score is the average of the 15 depression items, and the anxiety score is the average of the 10 anxiety items. Higher scores indicate worse level of depression and/or anxiety</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Post Traumatic Stress Disorder</condition>
    <arm_group>
      <arm_group_label>Aquatic physiotherapy treatment in warm water</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participant is placed supine in the water, supported by the physiotherapist as well as aqua noodles. The physiotherapist supports and moves the participant in the water and adapts to the participant's reaction.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>physical therapy</intervention_name>
      <description>Aquatic physiotherapy in warm water</description>
      <arm_group_label>Aquatic physiotherapy treatment in warm water</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Veteran and have been diagnosed with PTSD.&#xD;
  &#xD;
            -  Enjoy being in water.&#xD;
  &#xD;
            -  Have a desire for treatment and training in warm water.&#xD;
  &#xD;
            -  Will fill out questionnaires and respond to SMS messages related to treatment.&#xD;
  &#xD;
            -  Speak, read, and understand Danish fluently.&#xD;
  &#xD;
            -  Will set goals for future participation in local community activities.&#xD;
  &#xD;
            -  Have practical means to participate (Wednesday and Friday afternoons).&#xD;
  &#xD;
            -  Can attend treatment or receive assistance with transportation to treatment at&#xD;
               Tuborgvej, 2400 Copenhagen NV.&#xD;
  &#xD;
            -  Any substance abuse should be under control (self-medication, alcohol, and drugs)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  fear of water&#xD;
  &#xD;
            -  physical condition that hinders movement in water&#xD;
  &#xD;
            -  Fear of getting water in the ears&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Carsten Bogh Juhl, Professor</last_name>
      <role>Study Chair</role>
      <affiliation>Herlev &amp; Gentofte Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lone Nedergaard, bsc</last_name>
      <phone>+45 24288777</phone>
      <email>lone@vandfys.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Christina Nielsen, Master</last_name>
      <email>christina@vandfys.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Lions kollegiets varmtvandsbassin</name>
        <address>
          <city>Copenhagen</city>
          <zip>2400</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lone Nedergaard, bsc</last_name>
        <phone>+45 24288777</phone>
        <email>lone@vandfys.dk</email>
      </contact>
      <contact_backup>
        <last_name>Christina Nielsen, master</last_name>
        <email>christina@vandfys.dk</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>vandfys</investigator_affiliation>
      <investigator_full_name>Lone Nedergaard</investigator_full_name>
      <investigator_title>Principal investigator physiotherapist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stress Disorders, Traumatic</mesh_term>
      <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    </condition_browse>
    <!-- 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/NCT05992649
  org study id: V24
  nct id: NCT05992649
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Aquatic physiotherapy in warm water pool (AP) is thought to be a helpful treatment for
        veterans suffering from post-traumatic stress disorder (PTSD). A 24-week program can provide
        an opportunity to achieve positive results.
  
        Potentiel effects of AP for veterans with PTSD:
  
        Relaxation and stress reduction, anxiety and mood regulation, body awareness and grounding,
        strength and flexibility and social interactions and camaraderie.
  It is estimated that 5% of all veterans who have been deployed have PTSD. In Denmark the
        total number of deployments are about 27.000 from 1992 - 2012.
  
        The purpose of the project is to investigate the effect of aquatic physiotherapy treatment
        and physical training in 34-35 degree centigrade warm water in a 24-week program consisting
        of:
  
          1. st 8 weeks: 30 minutes treatment once a week.
  
          2. nd 8 weeks: 30 minutes treatment once a week +
  
        60 minutes of combined training and relaxation once a week.
  
        3rd 8 weeks: 60 minutes of combined training and relaxation once a week + an activity of own
        choice once a week.
  
        Hypothesis:
  
        Veterans with PTSD will experience a reduction in levels of PTSD symptoms.
  
        Methodical approach:
  
        Design: pilot project with an intervention group of 12 receiving treatment and physical
        training.
  
        Recruitment:
  
        The participants are recruited from Copenhagen Veteran Home, Høvelte Barracks Veteran Home
        and Military Psychiatric Outpatient Clinic, Rigshospitalet.
  
        cf. inclusion and exclusion criteria.
  
        No of participants to be recruited: 12
  
        Primary effect measures:
  
        Change of PTSD level from baseline using validated questionnaire PCL-M
  
        Secondary effect measures:
  
          1. Change of sleep disorders from baseline using validated questionnaire Pittsburgh Sleep
             Quality Index (PSQI).
  
          2. Change of self-perceived levels of depression and anxiety by questionnaire (Hopkins
             symptoms checklist)
  
          3. Change in self-perceived quality of wellbeing measured by questionnaire (WHO-5)
             Measurements to be taken before and after 24-weeks intervention
  
        Explorative measures:
  
        Change in functionality/ability with everyday life measured by questionnaire (The
        questionnaire method for assessing functionality/ability
  
        Ethical considerations:
  
        Participation in warm water treatment is considered without side effects or risks.
  
        Using exercise in warm water is part of general physiotherapeutic practice. The treatment is
        handled by experienced physiotherapists. The project complies with the Helsinki Declaration.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single group study
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Level of symptoms of PTSD
  time frame: 24-weeks
  description: Measured by self reported questionnaire PTSD Checklist for military (PCL-M). The self-report rating scale is 0-4 for each symptom (0 = Not at all, 1 = A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely).
  A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items. A score between 17-29 suggests little to no severity. A score between 28-29 suggests some PTSD symptoms.
  measure: Quality of sleep
  time frame: 24-weeks
  description: Measured by self reported questionnaire Pittsburgh Sleep Quality Index (PSQI). In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
  measure: Levels of symptoms of depression and anxiety
  time frame: 24-weeks
  description: Measured by self reported questionnaire Hopkins symptoms checklist. The scale for each question includes four categories of response ("Not at all," "A little," "Quite a bit," "Extremely," rated 1 to 4, respectively). Two scores are calculated: the total score is the average of all 25 items, while the depression score is the average of the 15 depression items, and the anxiety score is the average of the 10 anxiety items. Higher scores indicate worse level of depression and/or anxiety
  arm group label: Aquatic physiotherapy treatment in warm water
  arm group type: Experimental
  description: The participant is placed supine in the water, supported by the physiotherapist as well as aqua noodles. The physiotherapist supports and moves the participant in the water and adapts to the participant's reaction.
  intervention type: Other
  intervention name: physical therapy
  description: Aquatic physiotherapy in warm water
  arm group label: Aquatic physiotherapy treatment in warm water
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Carsten Bogh Juhl, Professor
  role: Study Chair
  affiliation: Herlev & Gentofte Hospital
  last name: Lone Nedergaard, bsc
  phone: +45 24288777
  email: lone@vandfys.dk
  last name: Christina Nielsen, Master
  email: christina@vandfys.dk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Denmark
  responsible party type: Principal Investigator
  investigator affiliation: vandfys
  investigator full name: Lone Nedergaard
  investigator title: Principal investigator physiotherapist
  mesh term: Stress Disorders, Traumatic
  mesh term: Stress Disorders, Post-Traumatic