<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/NCT04475653</url>
  </required_header>
  <id_info>
    <org_study_id>ildcarefitbit2017</org_study_id>
    <nct_id>NCT04475653</nct_id>
  </id_info>
  <brief_title>Benefit of Wearing an Activity Tracker in Sarcoidosis</brief_title>
  <acronym>ildfitbit</acronym>
  <official_title>Benefit of Wearing an Activity Tracker in Sarcoidosis</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>
    <collaborator>
      <agency>St. Antonius Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gelderse Vallei Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht University Medical Center</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>
      Sarcoidosis causes many disabling symptoms, including fatigue, muscle weakness, and exercise&#xD;
      limitations. Physical activity programs have been shown to improve physical performance and&#xD;
      decrease fatigue in sarcoidosis.&#xD;
&#xD;
      Objectives: The aim of this study was to evaluate (1) the effect of continuous activity&#xD;
      monitoring using an electronic activity tracker (AT), compared to controls, and (2) the&#xD;
      effect of additional personal coaching on exercise performance and fatigue of sarcoidosis&#xD;
      patients.&#xD;
&#xD;
      Method: This prospective, randomized clinical trial included 54 sarcoidosis patients who&#xD;
      received an AT (Group Ia: 27 with coaching and Group Ib: 27 without). Exercise capacity and&#xD;
      fatigue scores (Fatigue Assessment Scale) were evaluated at baseline and after three months.&#xD;
      A historical group of sarcoidosis patients (Group II; n=41) from an earlier study who did not&#xD;
      follow a physical activity program served as controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sarcoidosis patients often suffer not only from organ-related symptoms but also from&#xD;
      disabling non-specific, non-organ-related symptoms, such as fatigue, reduced muscle strength,&#xD;
      loss of physical condition, reduction of physical activity (PA) in daily life and pain.&#xD;
      Fatigue is the most frequently reported in sarcoidosis patients disregarding the clinical&#xD;
      presentation, varying from 50 to 90%. This may persist after other signs of sarcoidosis&#xD;
      activity have resolved, and adversely impacts major life areas, including quality of life&#xD;
      (QoL) and work ability.&#xD;
&#xD;
      So far, there is promising evidence for the benefits of physical training in sarcoidosis.&#xD;
      Interventions involving technology that is readily accessible on a daily basis to monitor&#xD;
      activity levels can support care providers in encouraging patients to achieve behavioral&#xD;
      changes. These interventions may be an effective strategy to provide PA-coaching without&#xD;
      increasing time demands on primary care providers. Moreover, they give patients an&#xD;
      opportunity to keep up a more active lifestyle with direct feedback and monitor their&#xD;
      physical performance over time. Counseling, guidance and support using e-health technology&#xD;
      had been found to be very helpful for patients who want to improve their PA. The use of&#xD;
      commercially available, technology-based wearable activity trackers (ATs) such as Fitbit is&#xD;
      growing for research and recreational purposes, both among healthy persons and among those&#xD;
      with chronic illness. Beneficial effects of AT-based counseling have been demonstrated in&#xD;
      patients with chronic diseases. In a recent study by our group we found that wearing an AT&#xD;
      stimulated patients to be more physically active.&#xD;
&#xD;
      The aim of this study was to evaluate (1) the effect of continuous activity monitoring using&#xD;
      an electronical AT and (2) the effect of additional personal coaching of sarcoidosis&#xD;
      patients. The outcome measures were exercise performance and fatigue.&#xD;
&#xD;
      Intervention All participants received a Fitbit for free. They were encouraged to improve&#xD;
      their physical fitness, which was assessed at baseline. The patients in the intervention&#xD;
      group (group Ia) engaged in a three-month physical therapist-guided activity program. The&#xD;
      guidance was based on the input from the AT and the questionnaires. The weekly FAS scores,&#xD;
      Fitbit-measured parameters and brief daily questions were combined in a web-based dashboard&#xD;
      accessible to the assigned physical therapist. The information was used for goal setting,&#xD;
      encouraging, and identifying barriers and facilitators for patients becoming more active. The&#xD;
      coaching procedure included weekly action planning and feedback, modelling of behaviors and&#xD;
      problem solving, and individual decision making by email and/or telephone. The coaching&#xD;
      physical therapist acted as facilitator, and assisted participants in making choices and&#xD;
      achieving success in terms of reaching self-selected goals.&#xD;
&#xD;
      Although the patients in group Ib did not receive the guidance from a physical therapist,&#xD;
      their daily activity was also computed with the Fitbit Charge HR (Brand name), and patients&#xD;
      were also able to use a Fitbit and monitor app to monitor their performance, questionnaire&#xD;
      results and progress.&#xD;
&#xD;
      Self-report feedback questionnaires at follow-up (12 weeks) were used to determine&#xD;
      participants' experience with data from the Fitbit tracker itself and coaching, if&#xD;
      applicable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2016</start_date>
  <completion_date type="Actual">December 18, 2017</completion_date>
  <primary_completion_date type="Actual">November 11, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This prospective, randomized clinical trial included 54 sarcoidosis patients who received an AT (Group Ia: 27 with coaching and Group Ib: 27 without). Exercise capacity and fatigue scores (Fatigue Assessment Scale) were evaluated at baseline and after three months. A historical group of sarcoidosis patients (Group II; n=41) from an earlier study who did not follow a physical activity program served as controls.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6 Minute Walking Distance (MWD)</measure>
    <time_frame>3 months</time_frame>
    <description>Change from baseline in 6 MWD in 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue monitoring</measure>
    <time_frame>3 months</time_frame>
    <description>Fatigue was measured with the 10-item Fatigue Assessment Scale (FAS) [9]. This questionnaire was filled out on a weekly basis. Outcome measure: Change from baseline in fatigue during 3 months.&#xD;
FAS scores 10 - 21: no fatigue (normal) FAS scores 22 - 50: substantial fatigue&#xD;
Subscores:&#xD;
fatigue: scores 22-34&#xD;
extreme fatigue: scores ≥ 35&#xD;
The Minimal Important Difference (MCID) is at least 4 points or 10% change of the baseline value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Steep ramp test (SRT)</measure>
    <time_frame>3 months</time_frame>
    <description>Exercise performance protocol on a cycle ergometer. Outcome: Change from baseline and after 3 months intervention of physical activity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lung function tests</measure>
    <time_frame>3 months</time_frame>
    <description>Forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) were measured with a pneumotachograph. The diffusing capacity of the lung for carbon monoxide (DLCO) was measured using the single-breath method (Masterlab, Jaeger, Würzburg, Germany). Values were expressed as a percentage of the predicted value (i.e., FVC%, FEV1%, and DLCO% respectively).&#xD;
Outcome measure: Change baseline and after 3 months intervention</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Sarcoidosis</condition>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Group coaching</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Performing physical activities with Activity tracker, coaching included</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Independant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Performing physical activities with Activity tracker, coaching NOT included</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Controls from former study (see Study description)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical Activity using an Activity Tracker</intervention_name>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Group Independant</arm_group_label>
    <arm_group_label>Group coaching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  participants being in a clinically stable condition&#xD;
&#xD;
          -  no change in initiated medical management during the preceding three months&#xD;
&#xD;
          -  having sufficient command of the Dutch language&#xD;
&#xD;
          -  having internet access at home or a compatible smartphone/tablet.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patients participated in a training program during the six months prior to inclusion were&#xD;
        excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marjolein Drent, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>ild care foundation</affiliation>
  </overall_official>
  <link>
    <url>https://www.ildcare.nl/index.php/benefits-of-e-health-based-coaching-of-physical-training-in-patients-with-ild/</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physical Activity</keyword>
  <keyword>Exercise Capacity</keyword>
  <keyword>Activity Tracker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoidosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04475653
org study id: ildcarefitbit2017
nct id: NCT04475653
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sarcoidosis causes many disabling symptoms, including fatigue, muscle weakness, and exercise
      limitations. Physical activity programs have been shown to improve physical performance and
      decrease fatigue in sarcoidosis.

      Objectives: The aim of this study was to evaluate (1) the effect of continuous activity
      monitoring using an electronic activity tracker (AT), compared to controls, and (2) the
      effect of additional personal coaching on exercise performance and fatigue of sarcoidosis
      patients.

      Method: This prospective, randomized clinical trial included 54 sarcoidosis patients who
      received an AT (Group Ia: 27 with coaching and Group Ib: 27 without). Exercise capacity and
      fatigue scores (Fatigue Assessment Scale) were evaluated at baseline and after three months.
      A historical group of sarcoidosis patients (Group II; n=41) from an earlier study who did not
      follow a physical activity program served as controls.
Sarcoidosis patients often suffer not only from organ-related symptoms but also from
      disabling non-specific, non-organ-related symptoms, such as fatigue, reduced muscle strength,
      loss of physical condition, reduction of physical activity (PA) in daily life and pain.
      Fatigue is the most frequently reported in sarcoidosis patients disregarding the clinical
      presentation, varying from 50 to 90%. This may persist after other signs of sarcoidosis
      activity have resolved, and adversely impacts major life areas, including quality of life
      (QoL) and work ability.

      So far, there is promising evidence for the benefits of physical training in sarcoidosis.
      Interventions involving technology that is readily accessible on a daily basis to monitor
      activity levels can support care providers in encouraging patients to achieve behavioral
      changes. These interventions may be an effective strategy to provide PA-coaching without
      increasing time demands on primary care providers. Moreover, they give patients an
      opportunity to keep up a more active lifestyle with direct feedback and monitor their
      physical performance over time. Counseling, guidance and support using e-health technology
      had been found to be very helpful for patients who want to improve their PA. The use of
      commercially available, technology-based wearable activity trackers (ATs) such as Fitbit is
      growing for research and recreational purposes, both among healthy persons and among those
      with chronic illness. Beneficial effects of AT-based counseling have been demonstrated in
      patients with chronic diseases. In a recent study by our group we found that wearing an AT
      stimulated patients to be more physically active.

      The aim of this study was to evaluate (1) the effect of continuous activity monitoring using
      an electronical AT and (2) the effect of additional personal coaching of sarcoidosis
      patients. The outcome measures were exercise performance and fatigue.

      Intervention All participants received a Fitbit for free. They were encouraged to improve
      their physical fitness, which was assessed at baseline. The patients in the intervention
      group (group Ia) engaged in a three-month physical therapist-guided activity program. The
      guidance was based on the input from the AT and the questionnaires. The weekly FAS scores,
      Fitbit-measured parameters and brief daily questions were combined in a web-based dashboard
      accessible to the assigned physical therapist. The information was used for goal setting,
      encouraging, and identifying barriers and facilitators for patients becoming more active. The
      coaching procedure included weekly action planning and feedback, modelling of behaviors and
      problem solving, and individual decision making by email and/or telephone. The coaching
      physical therapist acted as facilitator, and assisted participants in making choices and
      achieving success in terms of reaching self-selected goals.

      Although the patients in group Ib did not receive the guidance from a physical therapist,
      their daily activity was also computed with the Fitbit Charge HR (Brand name), and patients
      were also able to use a Fitbit and monitor app to monitor their performance, questionnaire
      results and progress.

      Self-report feedback questionnaires at follow-up (12 weeks) were used to determine
      participants' experience with data from the Fitbit tracker itself and coaching, if
      applicable.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This prospective, randomized clinical trial included 54 sarcoidosis patients who received an AT (Group Ia: 27 with coaching and Group Ib: 27 without). Exercise capacity and fatigue scores (Fatigue Assessment Scale) were evaluated at baseline and after three months. A historical group of sarcoidosis patients (Group II; n=41) from an earlier study who did not follow a physical activity program served as controls.
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: 6 Minute Walking Distance (MWD)
time frame: 3 months
description: Change from baseline in 6 MWD in 3 months
measure: Fatigue monitoring
time frame: 3 months
description: Fatigue was measured with the 10-item Fatigue Assessment Scale (FAS) [9]. This questionnaire was filled out on a weekly basis. Outcome measure: Change from baseline in fatigue during 3 months.
FAS scores 10 - 21: no fatigue (normal) FAS scores 22 - 50: substantial fatigue
Subscores:
fatigue: scores 22-34
extreme fatigue: scores ≥ 35
The Minimal Important Difference (MCID) is at least 4 points or 10% change of the baseline value.
measure: Steep ramp test (SRT)
time frame: 3 months
description: Exercise performance protocol on a cycle ergometer. Outcome: Change from baseline and after 3 months intervention of physical activity
measure: Lung function tests
time frame: 3 months
description: Forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) were measured with a pneumotachograph. The diffusing capacity of the lung for carbon monoxide (DLCO) was measured using the single-breath method (Masterlab, Jaeger, Würzburg, Germany). Values were expressed as a percentage of the predicted value (i.e., FVC%, FEV1%, and DLCO% respectively).
Outcome measure: Change baseline and after 3 months intervention
arm group label: Group coaching
arm group type: Active Comparator
description: Performing physical activities with Activity tracker, coaching included
arm group label: Group Independant
arm group type: Active Comparator
description: Performing physical activities with Activity tracker, coaching NOT included
arm group label: Controls
arm group type: Other
description: Controls from former study (see Study description)
intervention type: Behavioral
intervention name: Physical Activity using an Activity Tracker
arm group label: Controls
arm group label: Group Independant
arm group label: Group coaching
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Marjolein Drent, MD, PhD
role: Study Chair
affiliation: ild care foundation
url: https://www.ildcare.nl/index.php/benefits-of-e-health-based-coaching-of-physical-training-in-patients-with-ild/
description: Related Info
responsible party type: Sponsor
mesh term: Sarcoidosis
sharing ipd: No