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/NCT05996705</url>
    </required_header>
    <id_info>
      <org_study_id>40</org_study_id>
      <nct_id>NCT05996705</nct_id>
    </id_info>
    <brief_title>Fatigue in Patients With Rheumatoid Arthritis</brief_title>
    <official_title>Fatigue and Related Factors in Patients With Rheumatoid Arthritis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gaziler Physical Medicine and Rehabilitation Education and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gaziler Physical Medicine and Rehabilitation Education and Research Hospital</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>
        Rheumatoid arthritis (RA) is a disease characterized by autoimmune systemic inflammatory&#xD;
        polyarthritis, particularly affecting the joints of the hands. In addition to joint findings,&#xD;
        extra-articular symptoms such as muscle pain, fatigue, fever and malaise are also common.&#xD;
  &#xD;
        Fatigue is characterized by a feeling of extreme tiredness and persistent exhaustion. The&#xD;
        prevalence of fatigue is between 14% and 15% in healthy adults. Although fatigue is common in&#xD;
        patients with RA, it may remain in the background in clinical evaluation. The etiology of&#xD;
        fatigue in RA is related to inflammation, pain, psychosocial factors and sleep disturbance,&#xD;
        it has not been fully explained.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Rheumatoid arthritis (RA) is a disease characterized by autoimmune systemic inflammatory&#xD;
        polyarthritis, particularly affecting the joints of the hands. In addition to joint findings,&#xD;
        extra-articular symptoms such as muscle pain, fatigue, fever and malaise are also common.&#xD;
  &#xD;
        Fatigue is characterized by a feeling of extreme tiredness and persistent exhaustion. The&#xD;
        prevalence of fatigue is between 14% and 15% in healthy adults. Although fatigue is common in&#xD;
        patients with RA, it may remain in the background in clinical evaluation. The etiology of&#xD;
        fatigue in RA is related to inflammation, pain, psychosocial factors and sleep disturbance,&#xD;
        it has not been fully explained.&#xD;
  &#xD;
        There are various studies in the literature examining fatigue and factors associated with&#xD;
        fatigue in patients with RA. This study aimed to contribute to the literature by determining&#xD;
        the relationship of fatigue with physical function, pain values at rest and in motion,&#xD;
        gender, age, pain, disease activity, gender and disease duration in RA patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2014</start_date>
    <completion_date type="Actual">March 1, 2016</completion_date>
    <primary_completion_date type="Actual">March 1, 2016</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analogue Scale (VAS)</measure>
      <time_frame>through study completion, an average of one month</time_frame>
      <description>Pain levels were evaluated with Visual Analogue Scale (VAS) (0 = no pain and 10 = the worst pain you can imagine) in motion and at rest.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Disease Activity Score-28 (DAS28)</measure>
      <time_frame>through study completion, an average of one month</time_frame>
      <description>Disease activity was assessed with the Disease Activity Score-28 (DAS28). Since the signs and symptoms of rheumatoid arthritis are very diverse, the DAS 28 scale, which evaluates disease activity in a combination of many parameters and has validity, was developed. DAS28 score below 3.2 is considered as low disease activity, between 3.2 and 5.1 as moderate disease activity, and above 5.1 as high disease activity. According to ACR criteria, a score below 2.6 is considered remission.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health Assessment Questionnaire (HAQ)</measure>
      <time_frame>through study completion, an average of one month</time_frame>
      <description>Physical functioning and health-related quality of life were assessed with the Health Assessment Questionnaire (HAQ). The HAQ is approved by the American College of Rheumatology (ACR) for the assessment of physical function in rheumatoid arthritis. HAQ questions are given a score of 0 if the respondent can do them without any difficulty, 1 if they have some difficulty, 2 if they have a lot of difficulty and 3 if they cannot do them at all. The highest (worst) score in each domain is considered as the score of that domain. The HAQ score is obtained by summing the scores of the domains and dividing the total score by eight. If the HAQ score is 0-1, it is considered as mild-moderate disability, 1-2: moderate-severe disability, 2-3: severe-very severe disability.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fatigue Symptom Inventory (FSI).</measure>
      <time_frame>through study completion, an average of one month</time_frame>
      <description>Fatigue was assessed with the Fatigue Symptom Inventory (FSI). It is a scale consisting of 14 questions in total. The FSI assesses maximum, minimum, average and current levels of fatigue over the past week on an 11-point scale (0: not tired at all, 10: extremely tired).</description>
    </primary_outcome>
    <enrollment type="Actual">141</enrollment>
    <condition>Rheumatoid Arthritis</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Determining the relationship of fatigue with some parameters</intervention_name>
      <description>Determining the relationship of fatigue with physical function, pain values at rest and in motion, gender, age, pain, disease activity, gender and disease duration in RA patients.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients (38 males, 103 females) over 16 years of age who were diagnosed with RA according&#xD;
          to the 2002 ACR-EULAR RA criteria.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age between 16-85 years&#xD;
  &#xD;
            -  Patients diagnosed with RA according to 2002 ACR-EULAR RA criteria.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Malignancy&#xD;
  &#xD;
            -  Neurological disease&#xD;
  &#xD;
            -  Major psychiatric disorder&#xD;
  &#xD;
            -  Thyroid disease&#xD;
  &#xD;
            -  Anemia and hypovitaminosis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gizem Kılınç Kamacı, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Specialist</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ankara Physical Medicine and Rehabilitation Training and Research Hospital</name>
        <address>
          <city>Ankara</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Sandikci SC, Ozbalkan Z. Fatigue in rheumatic diseases. Eur J Rheumatol. 2015 Sep;2(3):109-113. doi: 10.5152/eurjrheum.2015.0029. Epub 2015 Sep 1.</citation>
      <PMID>27708942</PMID>
    </reference>
    <reference>
      <citation>Pollard LC, Choy EH, Gonzalez J, Khoshaba B, Scott DL. Fatigue in rheumatoid arthritis reflects pain, not disease activity. Rheumatology (Oxford). 2006 Jul;45(7):885-9. doi: 10.1093/rheumatology/kel021. Epub 2006 Jan 31.</citation>
      <PMID>16449363</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Gaziler Physical Medicine and Rehabilitation Education and Research Hospital</investigator_affiliation>
      <investigator_full_name>Yasin Demir</investigator_full_name>
      <investigator_title>Associate professor</investigator_title>
    </responsible_party>
    <keyword>fatigue</keyword>
    <keyword>disease activity</keyword>
    <keyword>rheumatoid arthritis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthritis</mesh_term>
      <mesh_term>Arthritis, Rheumatoid</mesh_term>
      <mesh_term>Fatigue</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05996705
  org study id: 40
  nct id: NCT05996705
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Rheumatoid arthritis (RA) is a disease characterized by autoimmune systemic inflammatory
        polyarthritis, particularly affecting the joints of the hands. In addition to joint findings,
        extra-articular symptoms such as muscle pain, fatigue, fever and malaise are also common.
  
        Fatigue is characterized by a feeling of extreme tiredness and persistent exhaustion. The
        prevalence of fatigue is between 14% and 15% in healthy adults. Although fatigue is common in
        patients with RA, it may remain in the background in clinical evaluation. The etiology of
        fatigue in RA is related to inflammation, pain, psychosocial factors and sleep disturbance,
        it has not been fully explained.
  Rheumatoid arthritis (RA) is a disease characterized by autoimmune systemic inflammatory
        polyarthritis, particularly affecting the joints of the hands. In addition to joint findings,
        extra-articular symptoms such as muscle pain, fatigue, fever and malaise are also common.
  
        Fatigue is characterized by a feeling of extreme tiredness and persistent exhaustion. The
        prevalence of fatigue is between 14% and 15% in healthy adults. Although fatigue is common in
        patients with RA, it may remain in the background in clinical evaluation. The etiology of
        fatigue in RA is related to inflammation, pain, psychosocial factors and sleep disturbance,
        it has not been fully explained.
  
        There are various studies in the literature examining fatigue and factors associated with
        fatigue in patients with RA. This study aimed to contribute to the literature by determining
        the relationship of fatigue with physical function, pain values at rest and in motion,
        gender, age, pain, disease activity, gender and disease duration in RA patients.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Visual Analogue Scale (VAS)
  time frame: through study completion, an average of one month
  description: Pain levels were evaluated with Visual Analogue Scale (VAS) (0 = no pain and 10 = the worst pain you can imagine) in motion and at rest.
  measure: Disease Activity Score-28 (DAS28)
  time frame: through study completion, an average of one month
  description: Disease activity was assessed with the Disease Activity Score-28 (DAS28). Since the signs and symptoms of rheumatoid arthritis are very diverse, the DAS 28 scale, which evaluates disease activity in a combination of many parameters and has validity, was developed. DAS28 score below 3.2 is considered as low disease activity, between 3.2 and 5.1 as moderate disease activity, and above 5.1 as high disease activity. According to ACR criteria, a score below 2.6 is considered remission.
  measure: Health Assessment Questionnaire (HAQ)
  time frame: through study completion, an average of one month
  description: Physical functioning and health-related quality of life were assessed with the Health Assessment Questionnaire (HAQ). The HAQ is approved by the American College of Rheumatology (ACR) for the assessment of physical function in rheumatoid arthritis. HAQ questions are given a score of 0 if the respondent can do them without any difficulty, 1 if they have some difficulty, 2 if they have a lot of difficulty and 3 if they cannot do them at all. The highest (worst) score in each domain is considered as the score of that domain. The HAQ score is obtained by summing the scores of the domains and dividing the total score by eight. If the HAQ score is 0-1, it is considered as mild-moderate disability, 1-2: moderate-severe disability, 2-3: severe-very severe disability.
  measure: Fatigue Symptom Inventory (FSI).
  time frame: through study completion, an average of one month
  description: Fatigue was assessed with the Fatigue Symptom Inventory (FSI). It is a scale consisting of 14 questions in total. The FSI assesses maximum, minimum, average and current levels of fatigue over the past week on an 11-point scale (0: not tired at all, 10: extremely tired).
  intervention type: Other
  intervention name: Determining the relationship of fatigue with some parameters
  description: Determining the relationship of fatigue with physical function, pain values at rest and in motion, gender, age, pain, disease activity, gender and disease duration in RA patients.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Gizem Kılınç Kamacı, MD
  role: Principal Investigator
  affiliation: Specialist
  facility: 
  country: Turkey
  citation: Sandikci SC, Ozbalkan Z. Fatigue in rheumatic diseases. Eur J Rheumatol. 2015 Sep;2(3):109-113. doi: 10.5152/eurjrheum.2015.0029. Epub 2015 Sep 1.
  PMID: 27708942
  citation: Pollard LC, Choy EH, Gonzalez J, Khoshaba B, Scott DL. Fatigue in rheumatoid arthritis reflects pain, not disease activity. Rheumatology (Oxford). 2006 Jul;45(7):885-9. doi: 10.1093/rheumatology/kel021. Epub 2006 Jan 31.
  PMID: 16449363
  responsible party type: Principal Investigator
  investigator affiliation: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
  investigator full name: Yasin Demir
  investigator title: Associate professor
  mesh term: Arthritis
  mesh term: Arthritis, Rheumatoid
  mesh term: Fatigue
  sharing ipd: No