<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/NCT04486261</url>
  </required_header>
  <id_info>
    <org_study_id>MCT16072020</org_study_id>
    <nct_id>NCT04486261</nct_id>
  </id_info>
  <brief_title>High-intensity Strength Training in Myositis</brief_title>
  <acronym>HI-STIM</acronym>
  <official_title>High-intensity Strength Training in Patients With Idiopathic Inflammatory Myopathies: Changes in Quality of Life, Muscle Strength, Function and Myocellular Parameters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study evaluates the effects of a high-intensity strength training in patients with&#xD;
      myositis with the primary outcome being quality of life (SF-36). The study is designed as a&#xD;
      parallel group randomised controlled trial with an intervention group and a control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overall aim:&#xD;
&#xD;
      To investigate the effect of high-intensity strength training on quality of life, muscle&#xD;
      strength, physical function, and disease activity in patients with myositis&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      60 myositis patients will be included in a 16-week high-intensity strength training study.&#xD;
      Patients will be randomly allocated into 2 groups (strength training and control) in a 1:1&#xD;
      ratio.&#xD;
&#xD;
      User involvement:&#xD;
&#xD;
      Myositis patients has been recruited to a patient advisory board. The advisory board's&#xD;
      objective is to give patient-oriented project feedback, thus improving the overall research&#xD;
      project.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      Two training session per week for 16 weeks. Sessions consists of 3 sets of each exercise&#xD;
      corresponding to 10 RM. Training progression will be accounted for and training loads will be&#xD;
      evaluated weekly. The training protocol will be a full-body protocol, i.e. all major muscle&#xD;
      groups will be engaged during each training session.&#xD;
&#xD;
      Outcomes:&#xD;
&#xD;
      The primary outcome is the Physical Component Summary Measure from the quality of life&#xD;
      questionnaire (SF-36). Secondary outcomes include strength measures, functional tests,&#xD;
      disease activity measures, questionnaires (e.g. International physical activity&#xD;
      questionnaire), DEXA whole body scans, blood samples and muscle biopsies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 30, 2021</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Actual">March 1, 2022</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life (health survey (SF-36) subscale: Physical Component Summary)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Quality of life will be evaluated with the short form (36) health survey (SF-36) subscale: Physical Component Summary. The scale ranges from 0 to 100 where 100 is the highest score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Leg power</measure>
    <time_frame>16 weeks</time_frame>
    <description>Power rig</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Handgrip strength</measure>
    <time_frame>16 weeks</time_frame>
    <description>Measured by a handheld dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Index 3</measure>
    <time_frame>16 weeks</time_frame>
    <description>A test of muscle strength in a series of muscles, carried out by the physician or physiotherapist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 seconds chair rise</measure>
    <time_frame>16 weeks</time_frame>
    <description>Participants are instructed to stand up and sit down on a chair as many times as possible in 30 sec.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed up-and-go</measure>
    <time_frame>16 weeks</time_frame>
    <description>Participants are instructed to rise from a chair walk 3 m forward, pass a marking and return to the chair and sit down as fast as possible</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2-minute walk test</measure>
    <time_frame>16 weeks</time_frame>
    <description>A 2-min maximal walk test where the participant is encouraged to cover the greatest distance possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance</measure>
    <time_frame>16 weeks</time_frame>
    <description>Short physical performance battery - balance part</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole-body, appendicular and lower-limb lean mass</measure>
    <time_frame>16 weeks</time_frame>
    <description>Measured by Dual-energy X-ray absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat-free mass, body fat and total mass</measure>
    <time_frame>16 weeks</time_frame>
    <description>Measured by bioimpedance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Global Activity</measure>
    <time_frame>16 weeks</time_frame>
    <description>Physician's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Activity</measure>
    <time_frame>16 weeks</time_frame>
    <description>Patient's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extra-muscular Disease Activity</measure>
    <time_frame>16 weeks</time_frame>
    <description>An assessment tool used by the physician to evaluate disease activity in various organ systems via a scoring system and a 0-10 cm scale, where the higher score indicates higher disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manual muscle test 8</measure>
    <time_frame>16 weeks</time_frame>
    <description>A test of muscle strength in a series of muscles, carried out by the physician</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Assessment Questionnaire (HAQ)</measure>
    <time_frame>16 weeks</time_frame>
    <description>HAQ is a questionnaire to evaluate patient reported disability. It has 8 categories with a range of questions. Each question is scored from 0 to 3 where 0 is no disability and 3 is unable to do.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Global assessment of disease damage</measure>
    <time_frame>16 weeks</time_frame>
    <description>Physician's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease damage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global assessment of disease damage</measure>
    <time_frame>16 weeks</time_frame>
    <description>Patient's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease damage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical history</measure>
    <time_frame>16 weeks</time_frame>
    <description>Questionnaire:&#xD;
Basic cardiovascular questionnaire concerning medical conditions, current medication, heart symptoms and smoking habits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-perceived physical activity levels</measure>
    <time_frame>16 weeks</time_frame>
    <description>International Physical Activity Questionnaire - long</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (health survey (SF-36) subscale: Mental component summary)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Quality of life will be evaluated with the short form (36) health survey (SF-36) subscale: Mental Component Summary. The scale ranges from 0 to 100 where 100 is the highest score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index (BMI)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Weight will be measured by scale (kg). Height will be measured by measuring (m). BMI will be derived from weight and height (kg/m^2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic and diastolic blood pressure</measure>
    <time_frame>16 weeks</time_frame>
    <description>Measured by blood pressure monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood samples (analysis of markers of af disease activity)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Plasma analysis: lipid profile, HbA1c, troponins, NT-proBNP, creatine kinase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrocardiography (ECG)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Standard 12-lead ECG at 25 mm/s is recorded and analyzed according to standard published criteria (48-50). According to the Minnesota coding the PQ-interval is measured and presence of 1st, 2nd (including Mobitz type 1 and 2), and 3rd degree of AV block are noted. Additional measures will include: P-wave duration (≥ 2.5 mm in any of leads II, III, aVF), QRS duration (≥ 120 ms in any of leads I, II, III, aVL, aVF), QTc duration (&gt; 450 ms), atrial fibrillation and flutter.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Muscle biopsies</measure>
    <time_frame>16 weeks</time_frame>
    <description>Muscle biopsies will be taken on a selected number of subjects from either the vastus lateralis or the tibialis anterior muscle, for the use in future analysis of i.e. muscle fibre size and distribution, myogenic stem cell activity, capillary density, muscle inflammation ect.</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical activity level</measure>
    <time_frame>16 weeks</time_frame>
    <description>Will be measured by activity tracker (watch)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Myositis</condition>
  <condition>Dermatomyositis</condition>
  <condition>Polymyositis</condition>
  <condition>Immune-Mediated Necrotizing Myopathy</condition>
  <arm_group>
    <arm_group_label>High-intensity strength training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>16 weeks of high-intensity strength training two times per week.&#xD;
Participants will receive the usual care in accordance to myositis (various DMARDs, different from patient to patient)&#xD;
Interventions:&#xD;
Other: high-intensity strength training Drug: Usual care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants receive the usual care in accordance to myositis (various DMARDs, different from patient to patient).&#xD;
Intervention:&#xD;
Drug: Usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-intensity strength training</intervention_name>
    <description>The high-intensity strength training protocol will consist of 2 training sessions per week. The first two weeks will be familiarisation training, where each exercise will be performed in three sets of 10 repetitions at an intensity of 15 repetitions maximum (RM). At week three each session will consist of 3 sets of each exercise corresponding to 10 RM, which will be kept for the remaining part of training intervention. The weights for each exercise will be adjusted throughout the intervention period, so the training load will correspond to 10 RM for each exercise in the entire intervention period.</description>
    <arm_group_label>High-intensity strength training</arm_group_label>
    <other_name>High-intensity resistance training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fulfilling the criteria for myositis by EULAR/ACR (Bottai et al., 2017; Lundberg et&#xD;
             al., 2017)&#xD;
&#xD;
          -  ≤ 5 mg/day Prednisolone&#xD;
&#xD;
          -  Stable dosage of immunosuppressive treatment for at least 1 months prior to inclusion&#xD;
             in the study&#xD;
&#xD;
          -  Myositis diagnosis at least 6 months prior to inclusion in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with sporadic inclusion body myositis and overlap myositis (myositis combined&#xD;
             with another autoimmune rheumatic diseases, except Sjögren's Syndrome)&#xD;
&#xD;
          -  Co-morbidity preventing resistance training (severe heart/lung-disease, uncontrolled&#xD;
             hypertension (systolic &gt; 160mmHg, diastolic &gt; 100mmHg), severe knee/hip arthritis)&#xD;
&#xD;
          -  Alcohol- and/or drug abuse. Defined by the guidelines issued by The Danish Health&#xD;
             Authority&#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_official>
    <last_name>Louise Pyndt Diederichsen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Bottai M, Tjarnlund A, Santoni G, Werth VP, Pilkington C, de Visser M, Alfredsson L, Amato AA, Barohn RJ, Liang MH, Singh JA, Aggarwal R, Arnardottir S, Chinoy H, Cooper RG, Danko K, Dimachkie MM, Feldman BM, Garcia-De La Torre I, Gordon P, Hayashi T, Katz JD, Kohsaka H, Lachenbruch PA, Lang BA, Li Y, Oddis CV, Olesinka M, Reed AM, Rutkowska-Sak L, Sanner H, Selva-O'Callaghan A, Wook Song Y, Vencovsky J, Ytterberg SR, Miller FW, Rider LG, Lundberg IE; International Myositis Classification Criteria Project consortium, the Euromyositis register and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository (JDRG) (UK and Ireland). EULAR/ACR classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups: a methodology report. RMD Open. 2017 Nov 14;3(2):e000507. doi: 10.1136/rmdopen-2017-000507. eCollection 2017.</citation>
    <PMID>29177080</PMID>
  </reference>
  <reference>
    <citation>Lundberg IE, Tjarnlund A, Bottai M, Werth VP, Pilkington C, de Visser M, Alfredsson L, Amato AA, Barohn RJ, Liang MH, Singh JA, Aggarwal R, Arnardottir S, Chinoy H, Cooper RG, Danko K, Dimachkie MM, Feldman BM, Garcia-De La Torre I, Gordon P, Hayashi T, Katz JD, Kohsaka H, Lachenbruch PA, Lang BA, Li Y, Oddis CV, Olesinska M, Reed AM, Rutkowska-Sak L, Sanner H, Selva-O'Callaghan A, Song YW, Vencovsky J, Ytterberg SR, Miller FW, Rider LG; International Myositis Classification Criteria Project Consortium, the Euromyositis Register, and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository (UK and Ireland). 2017 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Adult and Juvenile Idiopathic Inflammatory Myopathies and Their Major Subgroups. Arthritis Rheumatol. 2017 Dec;69(12):2271-2282. doi: 10.1002/art.40320. Epub 2017 Oct 27. Erratum In: Arthritis Rheumatol. 2018 Sep;70(9):1532.</citation>
    <PMID>29106061</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>April 25, 2022</last_update_submitted>
  <last_update_submitted_qc>April 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Louise Pyndt Diederichsen</investigator_full_name>
    <investigator_title>Consultant Rheumatologist, Associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Diseases</mesh_term>
    <mesh_term>Dermatomyositis</mesh_term>
    <mesh_term>Myositis</mesh_term>
    <mesh_term>Polymyositis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Due to GDPR-regulations IPD will not be available.</ipd_description>
  </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/NCT04486261
org study id: MCT16072020
nct id: NCT04486261
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effects of a high-intensity strength training in patients with
      myositis with the primary outcome being quality of life (SF-36). The study is designed as a
      parallel group randomised controlled trial with an intervention group and a control group.
Overall aim:

      To investigate the effect of high-intensity strength training on quality of life, muscle
      strength, physical function, and disease activity in patients with myositis

      Study design:

      60 myositis patients will be included in a 16-week high-intensity strength training study.
      Patients will be randomly allocated into 2 groups (strength training and control) in a 1:1
      ratio.

      User involvement:

      Myositis patients has been recruited to a patient advisory board. The advisory board's
      objective is to give patient-oriented project feedback, thus improving the overall research
      project.

      Intervention:

      Two training session per week for 16 weeks. Sessions consists of 3 sets of each exercise
      corresponding to 10 RM. Training progression will be accounted for and training loads will be
      evaluated weekly. The training protocol will be a full-body protocol, i.e. all major muscle
      groups will be engaged during each training session.

      Outcomes:

      The primary outcome is the Physical Component Summary Measure from the quality of life
      questionnaire (SF-36). Secondary outcomes include strength measures, functional tests,
      disease activity measures, questionnaires (e.g. International physical activity
      questionnaire), DEXA whole body scans, blood samples and muscle biopsies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Quality of life (health survey (SF-36) subscale: Physical Component Summary)
time frame: 16 weeks
description: Quality of life will be evaluated with the short form (36) health survey (SF-36) subscale: Physical Component Summary. The scale ranges from 0 to 100 where 100 is the highest score.
measure: Leg power
time frame: 16 weeks
description: Power rig
measure: Handgrip strength
time frame: 16 weeks
description: Measured by a handheld dynamometer
measure: Functional Index 3
time frame: 16 weeks
description: A test of muscle strength in a series of muscles, carried out by the physician or physiotherapist
measure: 30 seconds chair rise
time frame: 16 weeks
description: Participants are instructed to stand up and sit down on a chair as many times as possible in 30 sec.
measure: Timed up-and-go
time frame: 16 weeks
description: Participants are instructed to rise from a chair walk 3 m forward, pass a marking and return to the chair and sit down as fast as possible
measure: 2-minute walk test
time frame: 16 weeks
description: A 2-min maximal walk test where the participant is encouraged to cover the greatest distance possible.
measure: Balance
time frame: 16 weeks
description: Short physical performance battery - balance part
measure: Whole-body, appendicular and lower-limb lean mass
time frame: 16 weeks
description: Measured by Dual-energy X-ray absorptiometry
measure: Fat-free mass, body fat and total mass
time frame: 16 weeks
description: Measured by bioimpedance
measure: Physician Global Activity
time frame: 16 weeks
description: Physician's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease activity
measure: Patient Global Activity
time frame: 16 weeks
description: Patient's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease activity.
measure: Extra-muscular Disease Activity
time frame: 16 weeks
description: An assessment tool used by the physician to evaluate disease activity in various organ systems via a scoring system and a 0-10 cm scale, where the higher score indicates higher disease activity.
measure: Manual muscle test 8
time frame: 16 weeks
description: A test of muscle strength in a series of muscles, carried out by the physician
measure: Health Assessment Questionnaire (HAQ)
time frame: 16 weeks
description: HAQ is a questionnaire to evaluate patient reported disability. It has 8 categories with a range of questions. Each question is scored from 0 to 3 where 0 is no disability and 3 is unable to do.
measure: Physician Global assessment of disease damage
time frame: 16 weeks
description: Physician's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease damage.
measure: Patient Global assessment of disease damage
time frame: 16 weeks
description: Patient's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease damage.
measure: Medical history
time frame: 16 weeks
description: Questionnaire:
Basic cardiovascular questionnaire concerning medical conditions, current medication, heart symptoms and smoking habits
measure: Self-perceived physical activity levels
time frame: 16 weeks
description: International Physical Activity Questionnaire - long
measure: Quality of life (health survey (SF-36) subscale: Mental component summary)
time frame: 16 weeks
description: Quality of life will be evaluated with the short form (36) health survey (SF-36) subscale: Mental Component Summary. The scale ranges from 0 to 100 where 100 is the highest score.
measure: Body mass index (BMI)
time frame: 16 weeks
description: Weight will be measured by scale (kg). Height will be measured by measuring (m). BMI will be derived from weight and height (kg/m^2)
measure: Systolic and diastolic blood pressure
time frame: 16 weeks
description: Measured by blood pressure monitor
measure: Blood samples (analysis of markers of af disease activity)
time frame: 16 weeks
description: Plasma analysis: lipid profile, HbA1c, troponins, NT-proBNP, creatine kinase
measure: Electrocardiography (ECG)
time frame: 16 weeks
description: Standard 12-lead ECG at 25 mm/s is recorded and analyzed according to standard published criteria (48-50). According to the Minnesota coding the PQ-interval is measured and presence of 1st, 2nd (including Mobitz type 1 and 2), and 3rd degree of AV block are noted. Additional measures will include: P-wave duration (≥ 2.5 mm in any of leads II, III, aVF), QRS duration (≥ 120 ms in any of leads I, II, III, aVL, aVF), QTc duration (> 450 ms), atrial fibrillation and flutter.
measure: Muscle biopsies
time frame: 16 weeks
description: Muscle biopsies will be taken on a selected number of subjects from either the vastus lateralis or the tibialis anterior muscle, for the use in future analysis of i.e. muscle fibre size and distribution, myogenic stem cell activity, capillary density, muscle inflammation ect.
measure: Physical activity level
time frame: 16 weeks
description: Will be measured by activity tracker (watch)
arm group label: High-intensity strength training
arm group type: Experimental
description: 16 weeks of high-intensity strength training two times per week.
Participants will receive the usual care in accordance to myositis (various DMARDs, different from patient to patient)
Interventions:
Other: high-intensity strength training Drug: Usual care
arm group label: Control
arm group type: No Intervention
description: Participants receive the usual care in accordance to myositis (various DMARDs, different from patient to patient).
Intervention:
Drug: Usual care
intervention type: Other
intervention name: High-intensity strength training
description: The high-intensity strength training protocol will consist of 2 training sessions per week. The first two weeks will be familiarisation training, where each exercise will be performed in three sets of 10 repetitions at an intensity of 15 repetitions maximum (RM). At week three each session will consist of 3 sets of each exercise corresponding to 10 RM, which will be kept for the remaining part of training intervention. The weights for each exercise will be adjusted throughout the intervention period, so the training load will correspond to 10 RM for each exercise in the entire intervention period.
arm group label: High-intensity strength training
other name: High-intensity resistance training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Louise Pyndt Diederichsen, PhD
role: Principal Investigator
affiliation: Rigshospitalet, Denmark
facility: 
country: Denmark
citation: Bottai M, Tjarnlund A, Santoni G, Werth VP, Pilkington C, de Visser M, Alfredsson L, Amato AA, Barohn RJ, Liang MH, Singh JA, Aggarwal R, Arnardottir S, Chinoy H, Cooper RG, Danko K, Dimachkie MM, Feldman BM, Garcia-De La Torre I, Gordon P, Hayashi T, Katz JD, Kohsaka H, Lachenbruch PA, Lang BA, Li Y, Oddis CV, Olesinka M, Reed AM, Rutkowska-Sak L, Sanner H, Selva-O'Callaghan A, Wook Song Y, Vencovsky J, Ytterberg SR, Miller FW, Rider LG, Lundberg IE; International Myositis Classification Criteria Project consortium, the Euromyositis register and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository (JDRG) (UK and Ireland). EULAR/ACR classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups: a methodology report. RMD Open. 2017 Nov 14;3(2):e000507. doi: 10.1136/rmdopen-2017-000507. eCollection 2017.
PMID: 29177080
citation: Lundberg IE, Tjarnlund A, Bottai M, Werth VP, Pilkington C, de Visser M, Alfredsson L, Amato AA, Barohn RJ, Liang MH, Singh JA, Aggarwal R, Arnardottir S, Chinoy H, Cooper RG, Danko K, Dimachkie MM, Feldman BM, Garcia-De La Torre I, Gordon P, Hayashi T, Katz JD, Kohsaka H, Lachenbruch PA, Lang BA, Li Y, Oddis CV, Olesinska M, Reed AM, Rutkowska-Sak L, Sanner H, Selva-O'Callaghan A, Song YW, Vencovsky J, Ytterberg SR, Miller FW, Rider LG; International Myositis Classification Criteria Project Consortium, the Euromyositis Register, and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository (UK and Ireland). 2017 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Adult and Juvenile Idiopathic Inflammatory Myopathies and Their Major Subgroups. Arthritis Rheumatol. 2017 Dec;69(12):2271-2282. doi: 10.1002/art.40320. Epub 2017 Oct 27. Erratum In: Arthritis Rheumatol. 2018 Sep;70(9):1532.
PMID: 29106061
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Louise Pyndt Diederichsen
investigator title: Consultant Rheumatologist, Associate professor
mesh term: Muscular Diseases
mesh term: Dermatomyositis
mesh term: Myositis
mesh term: Polymyositis
sharing ipd: No
ipd description: Due to GDPR-regulations IPD will not be available.