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/NCT06001970</url>
    </required_header>
    <id_info>
      <org_study_id>313465</org_study_id>
      <nct_id>NCT06001970</nct_id>
    </id_info>
    <brief_title>Activity Pacing for Fatigue Management</brief_title>
    <official_title>Activity Pacing, Fatigue Management, and Self-regulation Strategies as a Promising Approach for Managing Fatigue Symptoms and for Promoting Physical Activity in Adults Who Experience Fatigue</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Northumbria University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Newcastle-upon-Tyne Hospitals NHS Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Northumbria University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This project will focus on perceived fatigue as a barrier to physical activity participation&#xD;
        and will explore if and how activity pacing, fatigue management, and self-regulation&#xD;
        strategies can help to overcome this barrier in adults with chronic conditions who experience&#xD;
        fatigue symptoms. The main aims are:&#xD;
  &#xD;
          1. To demonstrate the differences and similarities on activity pacing, perceived fatigue,&#xD;
             self-regulation, physical activity, and health-related quality of life in adults who&#xD;
             experience fatigue by comparing individuals who have been through an activity pacing&#xD;
             program or not.&#xD;
  &#xD;
          2. To explore thoughts, experiences, needs, and perspectives on activity pacing of adults&#xD;
             with fatigue and health professionals as well as any ideas for future development of an&#xD;
             optimal intervention.&#xD;
  &#xD;
        Participants will be invited to complete questionnaires on several variables (activity&#xD;
        pacing, physical activity, fatigue, health-related quality of life, and self-regulation of&#xD;
        physical activity). In addition, they will be invited to wear an Actigraph for 7 full days&#xD;
        and they will also be invited to a focus group interview.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Activity pacing is a fatigue management strategy that regulates energy and activity levels&#xD;
        while maintaining or increasing engagement in physical activity. This approach is&#xD;
        particularly beneficial for individuals with chronic conditions who experience significant&#xD;
        fatigue as they often struggle with sustained physical activity participation due to&#xD;
        recurring patterns of overexertion and subsequent fatigue or pain. Therefore, activity pacing&#xD;
        strategies are important because individuals learn to manage fatigue symptoms, optimize&#xD;
        physical activity behaviour, and accomplish a more stable activity pacing pattern, which will&#xD;
        improve their health-related quality of life and well-being.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 10, 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Perceived fatigue</measure>
      <time_frame>1 point in time measuring for the past 7 days</time_frame>
      <description>Fatigue Severity Scale is a 9-item questionnaire assessing the impact of perceived fatigue in adults with chronic disorders. FSS is valid and reliable to determine the impact of perceived fatigue among several clinical populations.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physical activity</measure>
      <time_frame>1 point in time measuring for the past 7 days</time_frame>
      <description>Self-reported PA: IPAQ is a 7-item measure that assesses the intensity of physical activity and sitting time in their daily lives . It has been validated in adults with stroke .</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Engagement in Pacing and Perceived Risk of Overactivity</measure>
      <time_frame>1 point in time measuring for the past 7 days</time_frame>
      <description>The Activity Pacing Questionnaire (APQ) is a 7-item measure assessing activity pacing and risk of overactivity. Reliability and construct validity have been investigated and the paper is in preparation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived Fatigue</measure>
      <time_frame>1 point in time measuring for the past 7 days</time_frame>
      <description>2)FACIT-F (version 4) is a 40-item questionnaire evaluating self-reported fatigue and its influence on everyday activities and function among adults with cancer and older people experiencing fatigue . FACIT-F is valid and reliable in several patient populations.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Objective Physical Activity</measure>
      <time_frame>7 days</time_frame>
      <description>Participants will be invited to wear an Actigraph for 7 full days.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Self-regulation</measure>
      <time_frame>1 point in time measuring for the past 7 days</time_frame>
      <description>Physical Activity Self-Regulation scale (PASR-12) is a 12-item measure assessing self-regulation for physical activity. PASR-12 has demonstrated validity and reliability in older adults.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related Quality of Life</measure>
      <time_frame>1 point in time measuring for the past 7 days</time_frame>
      <description>RAND-12 health status inventory is a 12-item questionnaire that evaluates the health-related quality of life. Literature supports acceptable construct validity and test-retest reliability of the RAND-12 among clinical populations.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Fatigue</condition>
    <condition>Chronic Condition</condition>
    <condition>Self-regulation</condition>
    <condition>Physical Activity</condition>
    <condition>Activity Pacing</condition>
    <arm_group>
      <arm_group_label>Adults who experience fatigue and have been through an activity pacing program</arm_group_label>
      <description>Adults with chronic conditions who experience fatigue recruited from Cresta Fatigue Clinic, Newcastle, UK</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Adults who experience fatigue and have not been through an activity pacing program</arm_group_label>
      <description>Adults with chronic conditions who experience fatigue recruited from the waiting list of Cresta Fatigue Clinic, Newcastle, UK</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Health professionals working on activity pacing</arm_group_label>
      <description>Health professionals who are working on Cresta Fatigue Clinic, Newcastle, UK</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Adults with chronic conditions who experience fatigue&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with a chronic condition&#xD;
  &#xD;
            -  Experience fatigue&#xD;
  &#xD;
            -  Ambulatory&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children&#xD;
  &#xD;
            -  Wheelchair users&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ioulia Barakou, MSc</last_name>
      <phone>07752464152</phone>
      <email>ioulia.barakou@northumbria.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Florentina Hettinga, PhD</last_name>
      <phone>0191 227 3989</phone>
      <email>florentina.hettinga@northumbria.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Northumbria University</name>
        <address>
          <city>Newcastle</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ioulia Barakou</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>physical activity behavior</keyword>
    <keyword>self-regulation</keyword>
    <keyword>fatigue</keyword>
    <keyword>chronic condition</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fatigue</mesh_term>
      <mesh_term>Chronic Disease</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/NCT06001970
  org study id: 313465
  nct id: NCT06001970
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This project will focus on perceived fatigue as a barrier to physical activity participation
        and will explore if and how activity pacing, fatigue management, and self-regulation
        strategies can help to overcome this barrier in adults with chronic conditions who experience
        fatigue symptoms. The main aims are:
  
          1. To demonstrate the differences and similarities on activity pacing, perceived fatigue,
             self-regulation, physical activity, and health-related quality of life in adults who
             experience fatigue by comparing individuals who have been through an activity pacing
             program or not.
  
          2. To explore thoughts, experiences, needs, and perspectives on activity pacing of adults
             with fatigue and health professionals as well as any ideas for future development of an
             optimal intervention.
  
        Participants will be invited to complete questionnaires on several variables (activity
        pacing, physical activity, fatigue, health-related quality of life, and self-regulation of
        physical activity). In addition, they will be invited to wear an Actigraph for 7 full days
        and they will also be invited to a focus group interview.
  Activity pacing is a fatigue management strategy that regulates energy and activity levels
        while maintaining or increasing engagement in physical activity. This approach is
        particularly beneficial for individuals with chronic conditions who experience significant
        fatigue as they often struggle with sustained physical activity participation due to
        recurring patterns of overexertion and subsequent fatigue or pain. Therefore, activity pacing
        strategies are important because individuals learn to manage fatigue symptoms, optimize
        physical activity behaviour, and accomplish a more stable activity pacing pattern, which will
        improve their health-related quality of life and well-being.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Perceived fatigue
  time frame: 1 point in time measuring for the past 7 days
  description: Fatigue Severity Scale is a 9-item questionnaire assessing the impact of perceived fatigue in adults with chronic disorders. FSS is valid and reliable to determine the impact of perceived fatigue among several clinical populations.
  measure: Physical activity
  time frame: 1 point in time measuring for the past 7 days
  description: Self-reported PA: IPAQ is a 7-item measure that assesses the intensity of physical activity and sitting time in their daily lives . It has been validated in adults with stroke .
  measure: Engagement in Pacing and Perceived Risk of Overactivity
  time frame: 1 point in time measuring for the past 7 days
  description: The Activity Pacing Questionnaire (APQ) is a 7-item measure assessing activity pacing and risk of overactivity. Reliability and construct validity have been investigated and the paper is in preparation.
  measure: Perceived Fatigue
  time frame: 1 point in time measuring for the past 7 days
  description: 2)FACIT-F (version 4) is a 40-item questionnaire evaluating self-reported fatigue and its influence on everyday activities and function among adults with cancer and older people experiencing fatigue . FACIT-F is valid and reliable in several patient populations.
  measure: Objective Physical Activity
  time frame: 7 days
  description: Participants will be invited to wear an Actigraph for 7 full days.
  measure: Self-regulation
  time frame: 1 point in time measuring for the past 7 days
  description: Physical Activity Self-Regulation scale (PASR-12) is a 12-item measure assessing self-regulation for physical activity. PASR-12 has demonstrated validity and reliability in older adults.
  measure: Health-related Quality of Life
  time frame: 1 point in time measuring for the past 7 days
  description: RAND-12 health status inventory is a 12-item questionnaire that evaluates the health-related quality of life. Literature supports acceptable construct validity and test-retest reliability of the RAND-12 among clinical populations.
  arm group label: Adults who experience fatigue and have been through an activity pacing program
  description: Adults with chronic conditions who experience fatigue recruited from Cresta Fatigue Clinic, Newcastle, UK
  arm group label: Adults who experience fatigue and have not been through an activity pacing program
  description: Adults with chronic conditions who experience fatigue recruited from the waiting list of Cresta Fatigue Clinic, Newcastle, UK
  arm group label: Health professionals working on activity pacing
  description: Health professionals who are working on Cresta Fatigue Clinic, Newcastle, UK
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ioulia Barakou, MSc
  phone: 07752464152
  email: ioulia.barakou@northumbria.ac.uk
  last name: Florentina Hettinga, PhD
  phone: 0191 227 3989
  email: florentina.hettinga@northumbria.ac.uk
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Fatigue
  mesh term: Chronic Disease