<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/NCT03764397</url>
  </required_header>
  <id_info>
    <org_study_id>18/0079</org_study_id>
    <nct_id>NCT03764397</nct_id>
  </id_info>
  <brief_title>Prehabilitation for Being Active. A Feasibility Study in Fibromyalgia</brief_title>
  <official_title>Development and Piloting of a Prehabilitation Behavioural Change and Physical Activity Intervention for Fibromyalgia Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Granada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Ulster</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad de Granada</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>
      Twelve people with FM will be recruited from the FM patient support groups. The investigators&#xD;
      will develop and test a 4-week prehabilitation educational programme (i.e., a behavioural&#xD;
      change intervention) consisting of meeting once per week (each approximately 1 - 1.5 hours).&#xD;
      These dynamic and interactive meetings will focus on education and skills training in:&#xD;
      exercise, activity cycling, pacing, causes of symptoms in FM (pain, fatigue, sleep&#xD;
      dysfunction) and their management.&#xD;
&#xD;
      Participants will be taught to set specific, measurable, achievable, realistic and timed&#xD;
      goals (SMART principle) that are valuable or meaningful to them. To do so, the participants&#xD;
      will identify a 'committed action' plan. The principles of cognitive behavioural therapy will&#xD;
      be used to address maladaptive thoughts (e.g., catastrophizing and fear avoidance) and to&#xD;
      manage stress (e.g., skills of relaxation). Participants will learn how to use of pedometers&#xD;
      to monitor physical activity.&#xD;
&#xD;
      After the 4-week prehabilitation educational programme, the participants will be encouraged&#xD;
      to engage in a 6-week gentle self-paced walking programme (with weekly telephone support).&#xD;
&#xD;
      The 6-week walking programme will consist of a simple pedometer-driven intervention.&#xD;
&#xD;
      Furthermore, the research team will telephone each participant at a prearranged time each&#xD;
      week to discuss progress, to document mean daily step count and to discuss a new physical&#xD;
      activity target (step count) for the subsequent week. Participants will record daily step&#xD;
      counts (pedometer-derived) in a walking dairy which will be used as raw data and mean steps&#xD;
      per day calculated. Where a participant declines telephone support, an alternative weekly&#xD;
      email or text/WhatsApp messages will be offered instead, where the same information will be&#xD;
      given and requested.&#xD;
&#xD;
      Before (baseline measurements) and right after the completion of the 4-week prehabilitation&#xD;
      educational programme as well as the 6-week gentle self-paced walking programme the same&#xD;
      measurements will be taken. By doing so, the investigators will evaluate short and mid-term&#xD;
      changes promoted by the prehabilitation programme. The participants will fill out the&#xD;
      following questionnaires: the Revised FM Impact Questionnaire, Pain Catastrophizing Scale,&#xD;
      Multidimensional Fatigue Inventory, Short-Form 36-item Health Survey, International Physical&#xD;
      Activity Questionnaire, Sedentary Behaviour Questionnaire, Exercise Self Efficacy&#xD;
      Questionnaire, Pittsburgh Sleep Quality Index questionnaire, and the modified 2011&#xD;
      preliminary FM criteria questionnaire.&#xD;
&#xD;
      Right after the completion of the prehabiliation intervention, all the participants will fill&#xD;
      out the treatment acceptability and credibility questionnaire. Right after the completion of&#xD;
      the walking programme, participants will be interviewed (semistructured face-to-face exit&#xD;
      interview lasting about 30-45 minutes) to explore their experiences of the study including&#xD;
      barriers to participation.&#xD;
&#xD;
      The main outcome of the study will be acceptability and credibility of the prehabilitation&#xD;
      intervention (treatment acceptability and credibility questionnaire. Additionally, the&#xD;
      success of the prehabilitation programme will be based on (i) number of sessions attended&#xD;
      (&gt;80%), (ii) number of drop outs (&lt;15%) and reasons for early withdrawal, (iii) number of&#xD;
      screening questionnaires completed and returned (&gt;80%).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 26, 2018</start_date>
  <completion_date type="Actual">November 26, 2018</completion_date>
  <primary_completion_date type="Actual">November 26, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability and credibility of the prehabilitation intervention</measure>
    <time_frame>Time point(s): once, right after the education programme. Time frame: An average of the past 4 weeks</time_frame>
    <description>The treatment acceptability and credibility questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of sessions attended</measure>
    <time_frame>Time point(s): once, right after the education programme. Time frame: The past 4 weeks</time_frame>
    <description>Percentage of participants attending to more than 80% of the education sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of drop outs and reasons for early withdrawal</measure>
    <time_frame>Time point(s): once, right after the education programme. Time frame: The 4 past weeks</time_frame>
    <description>Percentage of participants that do complete the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of questionnaires completed and returned</measure>
    <time_frame>Time point(s): once, right after the education programme. Time frame: The 4 past weeks</time_frame>
    <description>Percentage of participants that complete and return, at least, 80% of the questionnaires</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of fibromyalgia (also know as, impact of fibromyalgia)</measure>
    <time_frame>Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week</time_frame>
    <description>the Revised FM Impact Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week</time_frame>
    <description>0-10 NRS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain catastrophizing</measure>
    <time_frame>Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: &quot;in general&quot;, an average of the past 4 weeks.</time_frame>
    <description>Pain catastrophizing is the tendency to describe a pain experience in more exaggerated terms than the average person, to ruminate on it more (e.g., &quot;I kept thinking 'this is terrible'&quot;), and/or to feel more helpless about the experience (&quot;I thought it was never going to get better&quot;). Pain catastrophizing will be measured by means of the Pain Catastrophizing Scale is a 13-item questionnaire in which patients are asked to reflect on past painful experiences and indicate their thoughts or feelings about pain, on a 5-point scale. For this study, the total score (range 0-52) was used, where higher scores represent a more negative appraisal of pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week</time_frame>
    <description>the Multidimensional Fatigue Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>health related quality of life</measure>
    <time_frame>Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: &quot;in general&quot;, an average of the past 4 weeks.</time_frame>
    <description>the Short-Form Health Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>physical activity</measure>
    <time_frame>Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: the past 7 days</time_frame>
    <description>the International Physical Activity Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedentary Behaviour</measure>
    <time_frame>Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: the past week</time_frame>
    <description>Sedentary Behaviour Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>exercise self-efficacy</measure>
    <time_frame>Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: &quot;in general&quot;, an average of the past 4 weeks.</time_frame>
    <description>the Exercise Self Efficacy Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sleep quality</measure>
    <time_frame>Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: &quot;in general&quot;, an average of the past 4 weeks.</time_frame>
    <description>the Pittsburgh Sleep Quality Index questionnaire</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Prehabilitation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 4-week prehabilitation educational programme (i.e., a behavioral change intervention) and to pilot that prehabilitation in combination with a 6-week gentle self-paced walking programme (with weekly telephone support) in people with FM.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Prehabilitation for behavioural change</intervention_name>
    <description>The 4-week prehabilitation educational programme will consist of a meeting for one session (approximately 1 - 1.5 hours) per week. This behavioural change programme will involve a mixture of interactive and didactic sessions, facilitated by a physiotherapist, psychologists, and other health professionals. The purpose of the initial prehabilitation programme is to gain participant 'buy-in' to the programme, to assist participants engage with exercise, to help participants overcome barriers to exercise and improve self-efficacy for exercise. The prehabilitation phase will also enable participants to understand why and how to perform gentle self-paced exercise. After the prehabilitation programme, participants will be advised to engage in a 6-week gentle self-paced walking programme; i.e., a simple pedometer-driven walking programme with weekly telephone support.</description>
    <arm_group_label>Prehabilitation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have been diagnosed with FM by a medical practitioner, which will be&#xD;
             confirmed by the research team -i.e., the modified 2011 preliminary FM criteria&#xD;
             questionnaire (Appendix 14) by satisfying 'widespread pain index' (WPI) and 'symptom&#xD;
             severity scale' (SS) as follows, either WPI ≥7 and the SS ≥5, or the WPI is 3-6 and&#xD;
             the SS ≥9.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 16 years old.&#xD;
&#xD;
          -  Not able to communicate in English.&#xD;
&#xD;
          -  Mobilise dependently/aided.&#xD;
&#xD;
          -  Have any medical condition that would make exercise participation unsafe (for example;&#xD;
             heart disease, stroke, respiratory disease, severe mobility problems, severe arthritis&#xD;
             or inflammatory joint disease).&#xD;
&#xD;
          -  Are involved in ongoing litigation involving FM.&#xD;
&#xD;
          -  Are currently under active treatment by a physiotherapist or involved in any other&#xD;
             research studies.&#xD;
&#xD;
          -  Are pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ciara Hughes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ulster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The VINE center</name>
      <address>
        <city>Belfast</city>
        <zip>BT14 7DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Granada</investigator_affiliation>
    <investigator_full_name>Fernando Estévez-López</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Lifestyle</keyword>
  <keyword>Education</keyword>
  <keyword>Self-management</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>Proof-of-concept study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>To be decided</ipd_description>
  </patient_data>
  <!-- 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/NCT03764397
org study id: 18/0079
nct id: NCT03764397
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Twelve people with FM will be recruited from the FM patient support groups. The investigators
      will develop and test a 4-week prehabilitation educational programme (i.e., a behavioural
      change intervention) consisting of meeting once per week (each approximately 1 - 1.5 hours).
      These dynamic and interactive meetings will focus on education and skills training in:
      exercise, activity cycling, pacing, causes of symptoms in FM (pain, fatigue, sleep
      dysfunction) and their management.

      Participants will be taught to set specific, measurable, achievable, realistic and timed
      goals (SMART principle) that are valuable or meaningful to them. To do so, the participants
      will identify a 'committed action' plan. The principles of cognitive behavioural therapy will
      be used to address maladaptive thoughts (e.g., catastrophizing and fear avoidance) and to
      manage stress (e.g., skills of relaxation). Participants will learn how to use of pedometers
      to monitor physical activity.

      After the 4-week prehabilitation educational programme, the participants will be encouraged
      to engage in a 6-week gentle self-paced walking programme (with weekly telephone support).

      The 6-week walking programme will consist of a simple pedometer-driven intervention.

      Furthermore, the research team will telephone each participant at a prearranged time each
      week to discuss progress, to document mean daily step count and to discuss a new physical
      activity target (step count) for the subsequent week. Participants will record daily step
      counts (pedometer-derived) in a walking dairy which will be used as raw data and mean steps
      per day calculated. Where a participant declines telephone support, an alternative weekly
      email or text/WhatsApp messages will be offered instead, where the same information will be
      given and requested.

      Before (baseline measurements) and right after the completion of the 4-week prehabilitation
      educational programme as well as the 6-week gentle self-paced walking programme the same
      measurements will be taken. By doing so, the investigators will evaluate short and mid-term
      changes promoted by the prehabilitation programme. The participants will fill out the
      following questionnaires: the Revised FM Impact Questionnaire, Pain Catastrophizing Scale,
      Multidimensional Fatigue Inventory, Short-Form 36-item Health Survey, International Physical
      Activity Questionnaire, Sedentary Behaviour Questionnaire, Exercise Self Efficacy
      Questionnaire, Pittsburgh Sleep Quality Index questionnaire, and the modified 2011
      preliminary FM criteria questionnaire.

      Right after the completion of the prehabiliation intervention, all the participants will fill
      out the treatment acceptability and credibility questionnaire. Right after the completion of
      the walking programme, participants will be interviewed (semistructured face-to-face exit
      interview lasting about 30-45 minutes) to explore their experiences of the study including
      barriers to participation.

      The main outcome of the study will be acceptability and credibility of the prehabilitation
      intervention (treatment acceptability and credibility questionnaire. Additionally, the
      success of the prehabilitation programme will be based on (i) number of sessions attended
      (>80%), (ii) number of drop outs (<15%) and reasons for early withdrawal, (iii) number of
      screening questionnaires completed and returned (>80%).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acceptability and credibility of the prehabilitation intervention
time frame: Time point(s): once, right after the education programme. Time frame: An average of the past 4 weeks
description: The treatment acceptability and credibility questionnaire
measure: Number of sessions attended
time frame: Time point(s): once, right after the education programme. Time frame: The past 4 weeks
description: Percentage of participants attending to more than 80% of the education sessions
measure: Number of drop outs and reasons for early withdrawal
time frame: Time point(s): once, right after the education programme. Time frame: The 4 past weeks
description: Percentage of participants that do complete the study
measure: Number of questionnaires completed and returned
time frame: Time point(s): once, right after the education programme. Time frame: The 4 past weeks
description: Percentage of participants that complete and return, at least, 80% of the questionnaires
measure: Severity of fibromyalgia (also know as, impact of fibromyalgia)
time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
description: the Revised FM Impact Questionnaire
measure: Pain intensity
time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
description: 0-10 NRS
measure: Pain catastrophizing
time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
description: Pain catastrophizing is the tendency to describe a pain experience in more exaggerated terms than the average person, to ruminate on it more (e.g., "I kept thinking 'this is terrible'"), and/or to feel more helpless about the experience ("I thought it was never going to get better"). Pain catastrophizing will be measured by means of the Pain Catastrophizing Scale is a 13-item questionnaire in which patients are asked to reflect on past painful experiences and indicate their thoughts or feelings about pain, on a 5-point scale. For this study, the total score (range 0-52) was used, where higher scores represent a more negative appraisal of pain.
measure: Fatigue
time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
description: the Multidimensional Fatigue Inventory
measure: health related quality of life
time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
description: the Short-Form Health Survey
measure: physical activity
time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: the past 7 days
description: the International Physical Activity Questionnaire
measure: Sedentary Behaviour
time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: the past week
description: Sedentary Behaviour Questionnaire
measure: exercise self-efficacy
time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
description: the Exercise Self Efficacy Questionnaire
measure: sleep quality
time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
description: the Pittsburgh Sleep Quality Index questionnaire
arm group label: Prehabilitation group
arm group type: Experimental
description: A 4-week prehabilitation educational programme (i.e., a behavioral change intervention) and to pilot that prehabilitation in combination with a 6-week gentle self-paced walking programme (with weekly telephone support) in people with FM.
intervention type: Behavioral
intervention name: Prehabilitation for behavioural change
description: The 4-week prehabilitation educational programme will consist of a meeting for one session (approximately 1 - 1.5 hours) per week. This behavioural change programme will involve a mixture of interactive and didactic sessions, facilitated by a physiotherapist, psychologists, and other health professionals. The purpose of the initial prehabilitation programme is to gain participant 'buy-in' to the programme, to assist participants engage with exercise, to help participants overcome barriers to exercise and improve self-efficacy for exercise. The prehabilitation phase will also enable participants to understand why and how to perform gentle self-paced exercise. After the prehabilitation programme, participants will be advised to engage in a 6-week gentle self-paced walking programme; i.e., a simple pedometer-driven walking programme with weekly telephone support.
arm group label: Prehabilitation group
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Ciara Hughes, PhD
role: Principal Investigator
affiliation: Ulster University
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Universidad de Granada
investigator full name: Fernando Estévez-López
investigator title: PhD
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: Undecided
ipd description: To be decided