<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/NCT01689480</url>
  </required_header>
  <id_info>
    <org_study_id>1108153</org_study_id>
    <secondary_id>2011-A01186-35</secondary_id>
    <nct_id>NCT01689480</nct_id>
  </id_info>
  <brief_title>Prospective Study for 24-months of Physical Training Introduced in Lifestyle of Patients With FSHD : Tolerance, Sustainability and Efficiency of Unsupervised Training Program.</brief_title>
  <acronym>FSHD2</acronym>
  <official_title>Prospective Study for 24-months of Physical Training Introduced in Lifestyle of Patients With Facioscapulohumeral Dystrophy : Tolerance, Sustainability and Efficiency of Unsupervised Training Program.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Association Française contre les Myopathies (AFM), Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is now accepted that physical activity is not deleterious in myopathies, including&#xD;
      muscular dystrophies. In patients suffering from facioscapulohumeral dystrophy (FSHD),&#xD;
      aerobic training has been reported to be associated with physiological and functional&#xD;
      positive effects without alteration in quality of life. Van der Kooi et al. (2005) and Cup et&#xD;
      al. (2007) studies suggest that the combination of endurance and strength trainings is even&#xD;
      more relevant. However, only a few controlled and randomized studies have been conducted on&#xD;
      this topic and the impact of such training programs on skeletal muscle regenerative&#xD;
      capacities has not been addressed yet. Moreover, due to the fact that training programs are&#xD;
      mainly performed on short-term supervised periods, there is a lack of knowledge regarding&#xD;
      long-term effects, patient's autonomy and whether or not practice of regular exercise can be&#xD;
      maintained in patient's daily life. Also, only a few experiments report an integrative view&#xD;
      of potential benefits of such programs on functional, biological and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present project is the second phase of a study for which the first phase currently&#xD;
      financed by AFM is in progress and aims to establish a program of adapted physical training&#xD;
      performed at the patient's home under supervision. This program was developed in order to try&#xD;
      to meet the two following requirements: 1) to be compatible with the daily&#xD;
      professional/social activity of patients so it can be integrated in their life routine; 2) to&#xD;
      be intense enough so functional benefits can be induced. The first phase is a controlled and&#xD;
      randomized study where patients with FSHD participate in a 6-months supervised training&#xD;
      program combining aerobic and strength training sessions on an ergocycle.&#xD;
&#xD;
      This second phase of our research project aims to evaluate whether a long-term integration of&#xD;
      this adapted training program into patients' lifestyle is possible. The same tools, same&#xD;
      method and same measurements of training program will be used with remote monitoring, less&#xD;
      frequent as it was in the first phase, over a period of 24 months. This second experimental&#xD;
      work will also be based on multi-factorial evaluations, i.e. biological, physiological,&#xD;
      functional, and quality of life questionnaires and remains collaboration between Universities&#xD;
      of Saint Etienne (L. Féasson), Grenoble (B Wuyam) and Örebro (F Kadi) within the Rhône-Alpes&#xD;
      Reference Centre for Rare Neuromuscular Diseases (JC Antoine).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>patient's compliance</measure>
    <time_frame>at 24 months</time_frame>
    <description>Number of adapted physical activity sessions conducted over 2 years in patients with FSHD based on a theoretical program of three weekly sessions. A session will be considered valid based on the collection 1) time physical activity actually performed and 2) its intensity, both recorded from the cycle ergometer and a heart rate record.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Muscular Dystrophy, Facioscapulohumeral</condition>
  <arm_group>
    <arm_group_label>FSHD training</arm_group_label>
    <description>Only the patients who have participated to the FSHD1 study (NCT01116570) can be included in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FSHD training</intervention_name>
    <description>The training will consist in 3 sessions of 35 min of training per week at home on an ergocycle. The training will be divided in (i) 2 sessions of 30 min aerobic exercises at a constant but moderate (60% of maximal aerobic power, MAP) intensity followed with 5 sets of 10 revolutions at near-maximal intensity and (ii) an interval-training session. This latter session will consist in 5 min warm-up at 40% MAP followed by 5 times 1 min at 80% MAP (recovery = 4 min at 40% MAP) followed by 5 min of active recovery. A systematic supervision of the sessions by the coach will be performed by phone, by using the heart rate recordings and values of Analogic Visual Scale for pain and fatigue.</description>
    <arm_group_label>FSHD training</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with facioscapulohumeral dystrophy and who have participated to the FSHD1 study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Included in the FSHD1 study&#xD;
&#xD;
          -  Social Security regimen affiliated&#xD;
&#xD;
          -  Consent form signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cardiac or respiratory insufficiency&#xD;
&#xD;
          -  Cardiac pacemaker&#xD;
&#xD;
          -  Morbid obesity (BMI upper to 35)&#xD;
&#xD;
          -  Anti platelet therapy&#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>Léonard FEASSON, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Saint-Etienne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Grenbole</name>
      <address>
        <city>Grenoble</city>
        <zip>38000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Saint-Etienne</name>
      <address>
        <city>Saint-etienne</city>
        <zip>42000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>December 8, 2015</last_update_submitted>
  <last_update_submitted_qc>December 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Muscular Dystrophy</keyword>
  <keyword>Facioscapulohumeral</keyword>
  <keyword>Physical training</keyword>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Dystrophies</mesh_term>
    <mesh_term>Muscular Dystrophy, Facioscapulohumeral</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/NCT01689480
org study id: 1108153
secondary id: 2011-A01186-35
nct id: NCT01689480
lead sponsor: 
collaborator: 
has dmc: No
It is now accepted that physical activity is not deleterious in myopathies, including
      muscular dystrophies. In patients suffering from facioscapulohumeral dystrophy (FSHD),
      aerobic training has been reported to be associated with physiological and functional
      positive effects without alteration in quality of life. Van der Kooi et al. (2005) and Cup et
      al. (2007) studies suggest that the combination of endurance and strength trainings is even
      more relevant. However, only a few controlled and randomized studies have been conducted on
      this topic and the impact of such training programs on skeletal muscle regenerative
      capacities has not been addressed yet. Moreover, due to the fact that training programs are
      mainly performed on short-term supervised periods, there is a lack of knowledge regarding
      long-term effects, patient's autonomy and whether or not practice of regular exercise can be
      maintained in patient's daily life. Also, only a few experiments report an integrative view
      of potential benefits of such programs on functional, biological and quality of life.
The present project is the second phase of a study for which the first phase currently
      financed by AFM is in progress and aims to establish a program of adapted physical training
      performed at the patient's home under supervision. This program was developed in order to try
      to meet the two following requirements: 1) to be compatible with the daily
      professional/social activity of patients so it can be integrated in their life routine; 2) to
      be intense enough so functional benefits can be induced. The first phase is a controlled and
      randomized study where patients with FSHD participate in a 6-months supervised training
      program combining aerobic and strength training sessions on an ergocycle.

      This second phase of our research project aims to evaluate whether a long-term integration of
      this adapted training program into patients' lifestyle is possible. The same tools, same
      method and same measurements of training program will be used with remote monitoring, less
      frequent as it was in the first phase, over a period of 24 months. This second experimental
      work will also be based on multi-factorial evaluations, i.e. biological, physiological,
      functional, and quality of life questionnaires and remains collaboration between Universities
      of Saint Etienne (L. Féasson), Grenoble (B Wuyam) and Örebro (F Kadi) within the Rhône-Alpes
      Reference Centre for Rare Neuromuscular Diseases (JC Antoine).
observational model: Cohort
time perspective: Prospective
measure: patient's compliance
time frame: at 24 months
description: Number of adapted physical activity sessions conducted over 2 years in patients with FSHD based on a theoretical program of three weekly sessions. A session will be considered valid based on the collection 1) time physical activity actually performed and 2) its intensity, both recorded from the cycle ergometer and a heart rate record.
arm group label: FSHD training
description: Only the patients who have participated to the FSHD1 study (NCT01116570) can be included in this study.
intervention type: Other
intervention name: FSHD training
description: The training will consist in 3 sessions of 35 min of training per week at home on an ergocycle. The training will be divided in (i) 2 sessions of 30 min aerobic exercises at a constant but moderate (60% of maximal aerobic power, MAP) intensity followed with 5 sets of 10 revolutions at near-maximal intensity and (ii) an interval-training session. This latter session will consist in 5 min warm-up at 40% MAP followed by 5 times 1 min at 80% MAP (recovery = 4 min at 40% MAP) followed by 5 min of active recovery. A systematic supervision of the sessions by the coach will be performed by phone, by using the heart rate recordings and values of Analogic Visual Scale for pain and fatigue.
arm group label: FSHD training
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Léonard FEASSON, MD PhD
role: Principal Investigator
affiliation: CHU de Saint-Etienne
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Muscular Dystrophies
mesh term: Muscular Dystrophy, Facioscapulohumeral
sharing ipd: No