<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/NCT02208687</url>
  </required_header>
  <id_info>
    <org_study_id>2014/077</org_study_id>
    <nct_id>NCT02208687</nct_id>
  </id_info>
  <brief_title>Effectiveness and Cost-effectiveness of the Energetic Program</brief_title>
  <official_title>Energetic, a Self Management Group Program Aimed at Reconditioning and Social Participation in Persons With a Muscle Disease; a Multicentre Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ZonMw: The Netherlands Organisation for Health Research and Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Revalidatiefonds Nederland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Center of expertise Sneller herstel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fatigue is present in at least 60% of the patients with a muscle disease and can be the most&#xD;
      disabling symptom. In combination with other impairments, this often results in low levels of&#xD;
      physical activity and decreased social participation, leading to large societal costs.&#xD;
      Energetic is a self-management group program aimed at improving participation and physical&#xD;
      endurance in these patients. Our hypothesis is that Energetic results in improved&#xD;
      participation and improved physical endurance, less experienced fatigue and better quality of&#xD;
      life compared to usual care, without increasing health care costs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">November 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Canadian Occupational Performance Measure (COPM)</measure>
    <time_frame>3 months</time_frame>
    <description>Perceived activity performance. Three months will be the primary analysis. Effects at follow up will be measured at 6 and 12 months (see secondary outcome measures) (patient)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Canadian Occupational Performance Measure (COPM-satisfaction)</measure>
    <time_frame>3 months</time_frame>
    <description>Perceived satisfaction with performance (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Canadian Occupational Performance Measure (COPM-satisfaction)</measure>
    <time_frame>6 months</time_frame>
    <description>Perceived satisfaction with performance (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Canadian Occupational Performance Measure (COPM-satisfaction)</measure>
    <time_frame>15 months</time_frame>
    <description>Perceived satisfaction with performance (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Canadian Occupational Performance Measure (COPM-performance)</measure>
    <time_frame>6 months</time_frame>
    <description>Perceived performance in activities. Is primary outcome measure at 3 months, but data of 6 and 15 months follow up wil be used in a secondary analysis. (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Canadian Occupational Performance Measure (COPM-performance)</measure>
    <time_frame>15 months</time_frame>
    <description>Perceived performance in activities. Is primary outcome measure at 3 months, but data of 6 and 15 months follow up wil be used in a secondary analysis. (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity Card Sort (ACS)</measure>
    <time_frame>3 months</time_frame>
    <description>Participation measure:% retained activities.(patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity Card Sort (ACS)</measure>
    <time_frame>6 months</time_frame>
    <description>Participation measure:% retained activities.(patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity Card Sort (ACS)</measure>
    <time_frame>15 months</time_frame>
    <description>Participation measure:% retained activities.(patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six Minutes Walking Test (6MWT)</measure>
    <time_frame>3 months</time_frame>
    <description>physical endurance, sub-max test. (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six Minutes Walking Test (6MWT)</measure>
    <time_frame>6 months</time_frame>
    <description>physical endurance, sub-max test. (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six Minutes Walking Test (6MWT)</measure>
    <time_frame>15 months</time_frame>
    <description>physical endurance, sub-max test. (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care cost</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluation health care cost (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care cost</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluation health care cost (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care cost</measure>
    <time_frame>15 months</time_frame>
    <description>Evaluation health care cost (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Checklist Individual Strength subscale fatigue (CIS-fatigue)</measure>
    <time_frame>3 months</time_frame>
    <description>Impact of fatigue (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Checklist Individual Strength subscale fatigue (CIS-fatigue)</measure>
    <time_frame>6 months</time_frame>
    <description>Impact of fatigue (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Checklist Individual Strength subscale fatigue (CIS-fatigue)</measure>
    <time_frame>15 months</time_frame>
    <description>Impact of fatigue (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related Quality of Life: Short Form 36 (SF-36)</measure>
    <time_frame>3 months</time_frame>
    <description>Quality of life, used for evaluation of cost effectiveness (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related Quality of Life: Short Form 36 (SF-36)</measure>
    <time_frame>6 months</time_frame>
    <description>Quality of life, used for evaluation of cost effectiveness (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related Quality of Life: Short Form 36 (SF-36)</measure>
    <time_frame>15 months</time_frame>
    <description>Quality of life, used for evaluation of cost effectiveness (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Self-Efficacy Scale</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluation of the perceived self-efficacy (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Self-Efficacy Scale</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluation of the perceived self-efficacy (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Self-Efficacy Scale</measure>
    <time_frame>15 months</time_frame>
    <description>Evaluation of the perceived self-efficacy (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>3 months</time_frame>
    <description>Anxiety and depression (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>6 months</time_frame>
    <description>Anxiety and depression (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>15 months</time_frame>
    <description>Anxiety and depression (patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zarit Burden Inventory (ZBI)</measure>
    <time_frame>3 months</time_frame>
    <description>Perceived caregiver burden (caregiver)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zarit Burden Inventory (ZBI)</measure>
    <time_frame>6 months</time_frame>
    <description>Perceived caregiver burden (caregiver)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zarit Burden Inventory (ZBI)</measure>
    <time_frame>15 months</time_frame>
    <description>Perceived caregiver burden (caregiver)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Neuromuscular Diseases</condition>
  <arm_group>
    <arm_group_label>Energetic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Self management group program aimed at reconditioning and social participation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Energetic</intervention_name>
    <description>Physiotherapy and occupational therapy aimed at reconditioning and social participation.</description>
    <arm_group_label>Energetic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>Usual care</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  formal diagnosis of muscular disease, either FascioScapuloHumeral Dystrophy (FSHD),&#xD;
             Inclusion Body Myositis (IBM), Mitochondrial Myopathy (MM) or any other;&#xD;
&#xD;
          -  being severely fatigued&#xD;
&#xD;
          -  being cardiopulmonary stable and capable of aerobic training (as determined using a&#xD;
             submaximal cycling exercise test with ECG (electrocardiography) and advice from a&#xD;
             consultant cardiologist and pulmonologist);&#xD;
&#xD;
          -  being motivated, committed to the program, and 'ready to change' which is discussed&#xD;
             with the patient during the screening by a rehabilitation physician and an&#xD;
             occupational therapist; to this end, motivational interviewing will be used (including&#xD;
             a advantages/disadvantages matrix; a visual analogue scale (VAS) to rate the&#xD;
             importance of participation in de program; and a VAS to rate the confidence a patient&#xD;
             has that participation in the program is feasible)&#xD;
&#xD;
          -  being able to formulate at least 3 individual participation goals during the interview&#xD;
             with the occupational therapist.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active depression or other psychiatric disorder as indicated by a consultant&#xD;
             psychologist or by the medical history,&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  severe co-morbid condition,&#xD;
&#xD;
          -  having participated in the Energetic program before&#xD;
&#xD;
          -  a travel distance perceived as too burdensome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edith Cup, dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboudumc, department Rehabilitation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radboudumc</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>November 6, 2017</last_update_submitted>
  <last_update_submitted_qc>November 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Social Participation</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Self-Management</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Physical therapy</keyword>
  <keyword>Occupational therapy</keyword>
  <keyword>Group intervention</keyword>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuromuscular Diseases</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/NCT02208687
org study id: 2014/077
nct id: NCT02208687
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Fatigue is present in at least 60% of the patients with a muscle disease and can be the most
      disabling symptom. In combination with other impairments, this often results in low levels of
      physical activity and decreased social participation, leading to large societal costs.
      Energetic is a self-management group program aimed at improving participation and physical
      endurance in these patients. Our hypothesis is that Energetic results in improved
      participation and improved physical endurance, less experienced fatigue and better quality of
      life compared to usual care, without increasing health care costs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Canadian Occupational Performance Measure (COPM)
time frame: 3 months
description: Perceived activity performance. Three months will be the primary analysis. Effects at follow up will be measured at 6 and 12 months (see secondary outcome measures) (patient)
measure: Canadian Occupational Performance Measure (COPM-satisfaction)
time frame: 3 months
description: Perceived satisfaction with performance (patient)
measure: Canadian Occupational Performance Measure (COPM-satisfaction)
time frame: 6 months
description: Perceived satisfaction with performance (patient)
measure: Canadian Occupational Performance Measure (COPM-satisfaction)
time frame: 15 months
description: Perceived satisfaction with performance (patient)
measure: Canadian Occupational Performance Measure (COPM-performance)
time frame: 6 months
description: Perceived performance in activities. Is primary outcome measure at 3 months, but data of 6 and 15 months follow up wil be used in a secondary analysis. (patient)
measure: Canadian Occupational Performance Measure (COPM-performance)
time frame: 15 months
description: Perceived performance in activities. Is primary outcome measure at 3 months, but data of 6 and 15 months follow up wil be used in a secondary analysis. (patient)
measure: Activity Card Sort (ACS)
time frame: 3 months
description: Participation measure:% retained activities.(patient)
measure: Activity Card Sort (ACS)
time frame: 6 months
description: Participation measure:% retained activities.(patient)
measure: Activity Card Sort (ACS)
time frame: 15 months
description: Participation measure:% retained activities.(patient)
measure: Six Minutes Walking Test (6MWT)
time frame: 3 months
description: physical endurance, sub-max test. (patient)
measure: Six Minutes Walking Test (6MWT)
time frame: 6 months
description: physical endurance, sub-max test. (patient)
measure: Six Minutes Walking Test (6MWT)
time frame: 15 months
description: physical endurance, sub-max test. (patient)
measure: Health care cost
time frame: 3 months
description: Evaluation health care cost (patient)
measure: Health care cost
time frame: 6 months
description: Evaluation health care cost (patient)
measure: Health care cost
time frame: 15 months
description: Evaluation health care cost (patient)
measure: Checklist Individual Strength subscale fatigue (CIS-fatigue)
time frame: 3 months
description: Impact of fatigue (patient)
measure: Checklist Individual Strength subscale fatigue (CIS-fatigue)
time frame: 6 months
description: Impact of fatigue (patient)
measure: Checklist Individual Strength subscale fatigue (CIS-fatigue)
time frame: 15 months
description: Impact of fatigue (patient)
measure: Health-related Quality of Life: Short Form 36 (SF-36)
time frame: 3 months
description: Quality of life, used for evaluation of cost effectiveness (patient)
measure: Health-related Quality of Life: Short Form 36 (SF-36)
time frame: 6 months
description: Quality of life, used for evaluation of cost effectiveness (patient)
measure: Health-related Quality of Life: Short Form 36 (SF-36)
time frame: 15 months
description: Quality of life, used for evaluation of cost effectiveness (patient)
measure: General Self-Efficacy Scale
time frame: 3 months
description: Evaluation of the perceived self-efficacy (patient)
measure: General Self-Efficacy Scale
time frame: 6 months
description: Evaluation of the perceived self-efficacy (patient)
measure: General Self-Efficacy Scale
time frame: 15 months
description: Evaluation of the perceived self-efficacy (patient)
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: 3 months
description: Anxiety and depression (patient)
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: 6 months
description: Anxiety and depression (patient)
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: 15 months
description: Anxiety and depression (patient)
measure: Zarit Burden Inventory (ZBI)
time frame: 3 months
description: Perceived caregiver burden (caregiver)
measure: Zarit Burden Inventory (ZBI)
time frame: 6 months
description: Perceived caregiver burden (caregiver)
measure: Zarit Burden Inventory (ZBI)
time frame: 15 months
description: Perceived caregiver burden (caregiver)
arm group label: Energetic
arm group type: Experimental
description: Self management group program aimed at reconditioning and social participation
arm group label: Control group
arm group type: Other
description: Usual care
intervention type: Behavioral
intervention name: Energetic
description: Physiotherapy and occupational therapy aimed at reconditioning and social participation.
arm group label: Energetic
intervention type: Other
intervention name: Control group
description: Usual care
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Edith Cup, dr.
role: Principal Investigator
affiliation: Radboudumc, department Rehabilitation
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Neuromuscular Diseases