<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/NCT02243995</url>
  </required_header>
  <id_info>
    <org_study_id>METC 12-3-032</org_study_id>
    <nct_id>NCT02243995</nct_id>
  </id_info>
  <brief_title>Physical Training in Sarcoidosis Patients</brief_title>
  <official_title>Physical Training in Sarcoidosis Patients With Fatigue Complaints</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ild care foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Exercise intolerance, muscle weakness and fatigue complaints are frequent and persistent&#xD;
      problems in sarcoidosis. These physical impairments are disabling and affect quality of life&#xD;
      in a negative way. The aetiology of these physical impairments is multifactorial. Physical&#xD;
      inactivity can cause deconditioning, resulting in more perceived fatigue and muscle weakness.&#xD;
      These symptoms may be partially reversible following a structured physical training program.&#xD;
      However, scientific studies about physical training in sarcoidosis are lacking. Therefore,&#xD;
      the aim of the present study is to examine the changes in fatigue complaints, physical&#xD;
      functioning and quality of life (QOL) in patients with sarcoidosis following a 13-week&#xD;
      physical training program.&#xD;
&#xD;
      After obtaining written informed consent, sarcoidosis patients will start a 13-week physical&#xD;
      training program for three times a week. This training program includes peripheral muscle&#xD;
      training for both the upper and lower extremities (starting at 40% of the multiple-repetition&#xD;
      maximum) and endurance training consisting of walking on a treadmill (starting at 60% of the&#xD;
      speed of the 6-minute walk test) or cycling on a ergometer (starting at 50% of the Wmax).&#xD;
&#xD;
      Participants will be assessed at baseline (week 0), at the end (13 weeks) and 3 months after&#xD;
      ending the training. During these assessments, patients perform muscle strength (m.&#xD;
      quadriceps and m. biceps) and exercise tests (six-minute walk test and submaximal endurance&#xD;
      cycling test). They also complete several questionnaires:&#xD;
&#xD;
      Fatigue Assessment Scale (FAS), World Health Organization Quality of Life assessment&#xD;
      instrument-BREF (WHOQOL-BREF), Small Fiber Neuropathy Screening List (SFNSL), Medical&#xD;
      Research Council (MRC), Visual Analogue Scale (VAS) and Hospital Anxiety and Depression Scale&#xD;
      (HADS)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Cange in Fatigue Assessment Scale (FAS)at 3 months after end of the training</measure>
    <time_frame>baseline (week 0), at the end (week 13) and 3 months after ending the training</time_frame>
    <description>The 10-item FAS is a fatigue scale. Each item has a 5-point rating scale and FAS scores range from 10-50. FAS scores &lt;22 indicate nonfatigue persons and scores of 22-34 indicate fatigued persons.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Sarcoidosis</condition>
  <arm_group>
    <arm_group_label>Physical training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical training</intervention_name>
    <arm_group_label>Physical training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical training</intervention_name>
    <arm_group_label>Physical training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients are diagnosed with sarcoidosis according to the WASOG guideline.&#xD;
&#xD;
          -  Fatigued patients ((FAS-score ≥ 22 points) and/or a reduced six-minute walking&#xD;
             distance (predicted six-minute walking distance -50 m).&#xD;
&#xD;
          -  Patients who signed the consent form and are able to participate in a training&#xD;
             program.&#xD;
&#xD;
          -  Minimum age 18 years and maximum age 70 years.&#xD;
&#xD;
          -  Clinically stable: no exacerbation of complaints, or changes in initiated therapeutic&#xD;
             management during the preceding 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a cognitive failure, making them unable to understand questionnaires and&#xD;
             instructions.&#xD;
&#xD;
          -  Patients with a oncological, cardiac, neurological or orthopedic history making them&#xD;
             unable to participate in a training program.&#xD;
&#xD;
          -  Patients who are unfamiliar with the Dutch language, disabling them to understand&#xD;
             questionnaires and instructions.&#xD;
&#xD;
          -  Patients who participated in a physical training program six months prior to&#xD;
             inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antoine F. Lenssen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fysiomedica</name>
      <address>
        <city>Geleen</city>
        <state>Limburg</state>
        <zip>6161 ST</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>http://ildcare.eu</url>
    <description>ild care foundation</description>
  </link>
  <reference>
    <citation>Marcellis RG, Lenssen AF, de Vries GJ, Baughman RP, van der Grinten CP, Verschakelen JA, De Vries J, Drent M. Is there an added value of cardiopulmonary exercise testing in sarcoidosis patients? Lung. 2013 Feb;191(1):43-52. doi: 10.1007/s00408-012-9432-6. Epub 2012 Nov 9.</citation>
    <PMID>23138855</PMID>
  </reference>
  <reference>
    <citation>Marcellis RG, Lenssen AF, Elfferich MD, De Vries J, Kassim S, Foerster K, Drent M. Exercise capacity, muscle strength and fatigue in sarcoidosis. Eur Respir J. 2011 Sep;38(3):628-34. doi: 10.1183/09031936.00117710. Epub 2011 Mar 24.</citation>
    <PMID>21436356</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>February 18, 2013</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>January 5, 2018</last_update_submitted>
  <last_update_submitted_qc>January 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Training program</keyword>
  <keyword>Resistance training</keyword>
  <keyword>Endurance training</keyword>
  <keyword>Muscle strength</keyword>
  <keyword>Exercise capacity</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoidosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02243995
org study id: METC 12-3-032
nct id: NCT02243995
lead sponsor: 
collaborator: 
has dmc: Yes
Exercise intolerance, muscle weakness and fatigue complaints are frequent and persistent
      problems in sarcoidosis. These physical impairments are disabling and affect quality of life
      in a negative way. The aetiology of these physical impairments is multifactorial. Physical
      inactivity can cause deconditioning, resulting in more perceived fatigue and muscle weakness.
      These symptoms may be partially reversible following a structured physical training program.
      However, scientific studies about physical training in sarcoidosis are lacking. Therefore,
      the aim of the present study is to examine the changes in fatigue complaints, physical
      functioning and quality of life (QOL) in patients with sarcoidosis following a 13-week
      physical training program.

      After obtaining written informed consent, sarcoidosis patients will start a 13-week physical
      training program for three times a week. This training program includes peripheral muscle
      training for both the upper and lower extremities (starting at 40% of the multiple-repetition
      maximum) and endurance training consisting of walking on a treadmill (starting at 60% of the
      speed of the 6-minute walk test) or cycling on a ergometer (starting at 50% of the Wmax).

      Participants will be assessed at baseline (week 0), at the end (13 weeks) and 3 months after
      ending the training. During these assessments, patients perform muscle strength (m.
      quadriceps and m. biceps) and exercise tests (six-minute walk test and submaximal endurance
      cycling test). They also complete several questionnaires:

      Fatigue Assessment Scale (FAS), World Health Organization Quality of Life assessment
      instrument-BREF (WHOQOL-BREF), Small Fiber Neuropathy Screening List (SFNSL), Medical
      Research Council (MRC), Visual Analogue Scale (VAS) and Hospital Anxiety and Depression Scale
      (HADS)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cange in Fatigue Assessment Scale (FAS)at 3 months after end of the training
time frame: baseline (week 0), at the end (week 13) and 3 months after ending the training
description: The 10-item FAS is a fatigue scale. Each item has a 5-point rating scale and FAS scores range from 10-50. FAS scores <22 indicate nonfatigue persons and scores of 22-34 indicate fatigued persons.
arm group label: Physical training
arm group type: Experimental
intervention type: Other
intervention name: Physical training
arm group label: Physical training
intervention type: Behavioral
intervention name: Physical training
arm group label: Physical training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Antoine F. Lenssen, PhD
role: Principal Investigator
affiliation: Maastricht University Medical Centre
facility: 
country: Netherlands
url: http://ildcare.eu
description: ild care foundation
citation: Marcellis RG, Lenssen AF, de Vries GJ, Baughman RP, van der Grinten CP, Verschakelen JA, De Vries J, Drent M. Is there an added value of cardiopulmonary exercise testing in sarcoidosis patients? Lung. 2013 Feb;191(1):43-52. doi: 10.1007/s00408-012-9432-6. Epub 2012 Nov 9.
PMID: 23138855
citation: Marcellis RG, Lenssen AF, Elfferich MD, De Vries J, Kassim S, Foerster K, Drent M. Exercise capacity, muscle strength and fatigue in sarcoidosis. Eur Respir J. 2011 Sep;38(3):628-34. doi: 10.1183/09031936.00117710. Epub 2011 Mar 24.
PMID: 21436356
responsible party type: Sponsor
mesh term: Sarcoidosis