<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/NCT04461613</url>
  </required_header>
  <id_info>
    <org_study_id>2020/94587</org_study_id>
    <nct_id>NCT04461613</nct_id>
  </id_info>
  <brief_title>Physical Activity in Persons With Charcot-Marie-Tooth: Developing a Measurement Instrument</brief_title>
  <official_title>Developing and Testing Instrument to Measure Physical Activity in Charcot-Marie-Tooth: a Pilot Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian National Advisory Unit on Rare Disorders (NKSD)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Foreningen for Muskelsyke</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</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>
      The project will develop knowledge about physical activity in persons with&#xD;
      Charcot-Marie-Tooth (CMT) in Norway. We plan to explore instruments to measure physical&#xD;
      activity level for the target-group at the community level. We want to understand which type&#xD;
      of activities, activity intensities and how persons with CMT perform habitual physical&#xD;
      activity. Subsequently, a physical activity measurement instrument adapted to persons with&#xD;
      CMT will be developed. This instrument can be used in a future intervention project to&#xD;
      promote physical activity in this group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Charcot-Marie-Tooth (CMT) is a condition that potentially affects daily life function&#xD;
      including physical activity. Currently, there is no specific treatment. To prevent physical&#xD;
      deconditioning, physical activity recommended. Furthermore, other studies have found the&#xD;
      benefit of being physically active, including people with neuromuscular disorders (NMD). .&#xD;
&#xD;
      Apart from the physical activity in a rehabilitation center, physical activity also needs to&#xD;
      be maintained at the community level in people's everyday life. To measure physical activity&#xD;
      level in the community, we need an instrument that is designed for doing so. A questionnaire&#xD;
      can be used to collect information about type of activity, activity duration and intensity.&#xD;
      The instruments available so far to measure physical activity at the community level are not&#xD;
      specifically adapted to persons with CMT. Therefore, this study will focus on revising the&#xD;
      questionnaire based on the inputs from persons with CMT themselves. Furthermore, the revised&#xD;
      questionnaire will be compared with the original one in addition to yet another instrument.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2021</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Two groups of people with CMT will compare an original International Physical Activity Questionnaire short form (IPAQ-sf) and a revised one with a 7-days physical activity diary. The first group will begin with the original version and end with a revised one. The second group will begin with a revised IPAQ-sf and end with the original one. Both groups will also need to complete a 7-days activity diary two times.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
    <masking_description>Study participants will receive an unmarked envelope consisting of all study material. The order of the study questionnaires inside the unmarked envelope will be randomized and sealed by the first researcher. The first researcher will give them to the second researcher who will again shuffle the envelopes order (without the first researcher present) before giving them to the care provider. The care provider will give the study envelope to the study participants. Therefore, investigators and care provider will be masked to the contents of the unmarked study envelope and cannot selectively assign the participants to a certain group. However, the study participants might recognize the original IPAQ if she/he received this questionnaire in the past.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Total physical activity duration</measure>
    <time_frame>16 days</time_frame>
    <description>Correlations of the total physical activity duration measured using original and revised International Physical Activity Questionnaire short form (IPAQ-sf) with an activity diary (in minutes/week).&#xD;
The original IPAQ-sf has been used in Norwegian context and available in Norwegian language. It has a criterion validity of 0.30 (95% CI 0.23-0.36) against accelerometer count and 0.30-0.46 for correlation with a physical activity diary physical activity level (in MET minutes/week). The content of the revised IPAQ-sf was formulated based on the inputs from experts, including the persons with CMT themselves in our reference group. The revised IPAQ-sf will be compared with the original IPAQ-sf in this pilot project.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical activity duration for different intensities from original and revised IPAQ-sf</measure>
    <time_frame>16 days</time_frame>
    <description>Correlations of the physical activity duration at three different intensities: high/vigorous, moderate, and light/walking, measured using original and revised IPAQ-sf with an activity diary (in minutes/week).&#xD;
Both original and revised IPAQ-sf can provide description of physical activity level in three different intensities: high/vigorous, moderate, and light/walking. In the activity diary, the Borg's scale will be used to describe intensity in categories: high, moderate, and light. The Borg's scale has weighted mean validity coefficients 0.57-0.72 for various physiological measurements, including: heart rate, blood lactate, %VO2max, VO2, ventilation, and respiration rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative inputs from the pilot study participants for all of the study instruments</measure>
    <time_frame>16 days</time_frame>
    <description>Inputs and comments from pilot study participants for the original IPAQ-sf, revised IPAQ-sf, and activity diary.&#xD;
In this pilot project, we provided field for comments for each point of question in all three questionnaires: original IPAQ-sf, revised IPAQ-sf, and physical activity diary. These qualitative inputs will be analysed for further development and improvement of the study instruments.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Hereditary Motor and Sensory Neuropathy</condition>
  <condition>Charcot-Marie-Tooth</condition>
  <condition>Polyneuropathies</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the first week, this group will receive a physical activity diary and be required to fill it out for 7 days. After completion of the activity diary, group 1 will receive an original International Physical Activity Questionnaire short form (IPAQ-sf). Group 1 will be asked to fill it out with information about physical activities in the last 7 days.&#xD;
In the second week, the group will need to fill another physical activity diary for 7 days. After the completion of this, group 1 will be asked to fill a revised version of IPAQ-sf to describe physical activities in the last 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the first week, this group will receive a physical activity diary and be required to fill it out for 7 days. After completion of the activity diary, group 2 will receive a revised version of International Physical Activity Questionnaire short form (IPAQ-sf). Group 2 will be asked to fill it out with information about physical activities in the last 7 days.&#xD;
In the second week, the group will need to fill another physical activity diary for 7 days. After the completion of this, group 2 will be asked to fill an original IPAQ-sf to describe physical activities in the last 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Original IPAQ followed by a revised one.</intervention_name>
    <description>Comparing two questionnaires (a revised version and an original International Physical Activity Questionnaire short form) with an activity diary.</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Revised IPAQ followed by an original one.</intervention_name>
    <description>Comparing two questionnaires (a revised version and an original International Physical Activity Questionnaire short form) with an activity diary.</description>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults with a genetically confirmed CMT diagnosis.&#xD;
&#xD;
          -  Residing in Norway&#xD;
&#xD;
          -  Age between 18 to 65 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Had major surgery within three months prior to the study period.&#xD;
&#xD;
          -  Experiencing serious illness (e.g. bedridden, hospitalized).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristin Ørstavik, MD, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>February 23, 2021</last_update_submitted>
  <last_update_submitted_qc>February 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Kristin Ørstavik</investigator_full_name>
    <investigator_title>Consultant in Neurology and Head of Section for Rare Neuromuscular disorders including EMAN, Department of Neurology, Oslo University Hospital</investigator_title>
  </responsible_party>
  <keyword>CMT</keyword>
  <keyword>IPAQ</keyword>
  <keyword>NMD</keyword>
  <keyword>Charcot-Marie-Tooth</keyword>
  <keyword>International Physical Activity Questionnaire</keyword>
  <keyword>neuromuscular disorders</keyword>
  <keyword>activity diary</keyword>
  <keyword>hereditary neuropathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyneuropathies</mesh_term>
    <mesh_term>Charcot-Marie-Tooth Disease</mesh_term>
    <mesh_term>Nerve Compression Syndromes</mesh_term>
    <mesh_term>Hereditary Sensory and Motor Neuropathy</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/NCT04461613
org study id: 2020/94587
nct id: NCT04461613
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The project will develop knowledge about physical activity in persons with
      Charcot-Marie-Tooth (CMT) in Norway. We plan to explore instruments to measure physical
      activity level for the target-group at the community level. We want to understand which type
      of activities, activity intensities and how persons with CMT perform habitual physical
      activity. Subsequently, a physical activity measurement instrument adapted to persons with
      CMT will be developed. This instrument can be used in a future intervention project to
      promote physical activity in this group.
Charcot-Marie-Tooth (CMT) is a condition that potentially affects daily life function
      including physical activity. Currently, there is no specific treatment. To prevent physical
      deconditioning, physical activity recommended. Furthermore, other studies have found the
      benefit of being physically active, including people with neuromuscular disorders (NMD). .

      Apart from the physical activity in a rehabilitation center, physical activity also needs to
      be maintained at the community level in people's everyday life. To measure physical activity
      level in the community, we need an instrument that is designed for doing so. A questionnaire
      can be used to collect information about type of activity, activity duration and intensity.
      The instruments available so far to measure physical activity at the community level are not
      specifically adapted to persons with CMT. Therefore, this study will focus on revising the
      questionnaire based on the inputs from persons with CMT themselves. Furthermore, the revised
      questionnaire will be compared with the original one in addition to yet another instrument.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Two groups of people with CMT will compare an original International Physical Activity Questionnaire short form (IPAQ-sf) and a revised one with a 7-days physical activity diary. The first group will begin with the original version and end with a revised one. The second group will begin with a revised IPAQ-sf and end with the original one. Both groups will also need to complete a 7-days activity diary two times.
primary purpose: Screening
masking: Double (Care Provider, Investigator)
masking description: Study participants will receive an unmarked envelope consisting of all study material. The order of the study questionnaires inside the unmarked envelope will be randomized and sealed by the first researcher. The first researcher will give them to the second researcher who will again shuffle the envelopes order (without the first researcher present) before giving them to the care provider. The care provider will give the study envelope to the study participants. Therefore, investigators and care provider will be masked to the contents of the unmarked study envelope and cannot selectively assign the participants to a certain group. However, the study participants might recognize the original IPAQ if she/he received this questionnaire in the past.
measure: Total physical activity duration
time frame: 16 days
description: Correlations of the total physical activity duration measured using original and revised International Physical Activity Questionnaire short form (IPAQ-sf) with an activity diary (in minutes/week).
The original IPAQ-sf has been used in Norwegian context and available in Norwegian language. It has a criterion validity of 0.30 (95% CI 0.23-0.36) against accelerometer count and 0.30-0.46 for correlation with a physical activity diary physical activity level (in MET minutes/week). The content of the revised IPAQ-sf was formulated based on the inputs from experts, including the persons with CMT themselves in our reference group. The revised IPAQ-sf will be compared with the original IPAQ-sf in this pilot project.
measure: Physical activity duration for different intensities from original and revised IPAQ-sf
time frame: 16 days
description: Correlations of the physical activity duration at three different intensities: high/vigorous, moderate, and light/walking, measured using original and revised IPAQ-sf with an activity diary (in minutes/week).
Both original and revised IPAQ-sf can provide description of physical activity level in three different intensities: high/vigorous, moderate, and light/walking. In the activity diary, the Borg's scale will be used to describe intensity in categories: high, moderate, and light. The Borg's scale has weighted mean validity coefficients 0.57-0.72 for various physiological measurements, including: heart rate, blood lactate, %VO2max, VO2, ventilation, and respiration rate.
measure: Qualitative inputs from the pilot study participants for all of the study instruments
time frame: 16 days
description: Inputs and comments from pilot study participants for the original IPAQ-sf, revised IPAQ-sf, and activity diary.
In this pilot project, we provided field for comments for each point of question in all three questionnaires: original IPAQ-sf, revised IPAQ-sf, and physical activity diary. These qualitative inputs will be analysed for further development and improvement of the study instruments.
arm group label: Group 1
arm group type: Experimental
description: In the first week, this group will receive a physical activity diary and be required to fill it out for 7 days. After completion of the activity diary, group 1 will receive an original International Physical Activity Questionnaire short form (IPAQ-sf). Group 1 will be asked to fill it out with information about physical activities in the last 7 days.
In the second week, the group will need to fill another physical activity diary for 7 days. After the completion of this, group 1 will be asked to fill a revised version of IPAQ-sf to describe physical activities in the last 7 days.
arm group label: Group 2
arm group type: Experimental
description: In the first week, this group will receive a physical activity diary and be required to fill it out for 7 days. After completion of the activity diary, group 2 will receive a revised version of International Physical Activity Questionnaire short form (IPAQ-sf). Group 2 will be asked to fill it out with information about physical activities in the last 7 days.
In the second week, the group will need to fill another physical activity diary for 7 days. After the completion of this, group 2 will be asked to fill an original IPAQ-sf to describe physical activities in the last 7 days.
intervention type: Other
intervention name: Original IPAQ followed by a revised one.
description: Comparing two questionnaires (a revised version and an original International Physical Activity Questionnaire short form) with an activity diary.
arm group label: Group 1
intervention type: Other
intervention name: Revised IPAQ followed by an original one.
description: Comparing two questionnaires (a revised version and an original International Physical Activity Questionnaire short form) with an activity diary.
arm group label: Group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Kristin Ørstavik, MD, Ph.D.
role: Principal Investigator
affiliation: Oslo University Hospital
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Kristin Ørstavik
investigator title: Consultant in Neurology and Head of Section for Rare Neuromuscular disorders including EMAN, Department of Neurology, Oslo University Hospital
mesh term: Polyneuropathies
mesh term: Charcot-Marie-Tooth Disease
mesh term: Nerve Compression Syndromes
mesh term: Hereditary Sensory and Motor Neuropathy
sharing ipd: No