<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/NCT03837834</url>
  </required_header>
  <id_info>
    <org_study_id>201682-4100</org_study_id>
    <nct_id>NCT03837834</nct_id>
  </id_info>
  <brief_title>Effects of 6 Weeks High-intensity Interval Training Among Spinal Cord Injury</brief_title>
  <official_title>Effects of 6 Weeks High-intensity Interval Training on Muscle Strength and Cardiorespiratory Response Among Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiti Teknologi Mara</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universiti Teknologi Mara</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 training consists of 6 weeks of functional electrical stimulation leg cycling exercise&#xD;
      (FES-LCE) program. The training program comprises of 2 visits per week. Each visit consists&#xD;
      of FES-LCE for 45 minutes. Throughout the 6 weeks program, there will be testing/assessment&#xD;
      sessions on week 1, week 3 and week 6. The FES will be applied via surface electrodes and the&#xD;
      stimulation intensity based on the participant's tolerance level.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">September 5, 2019</completion_date>
  <primary_completion_date type="Actual">September 5, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of peak torque of Quadriceps and Hamstring</measure>
    <time_frame>Changes of peak torque at 6 week</time_frame>
    <description>Isometric peak torque for quadriceps and hamstring will be measured using Biodex isokinetic machine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of peak VO2</measure>
    <time_frame>Changes of peak VO2 at 6 week</time_frame>
    <description>Peak VO2 will be measured using Cosmed Quark CPET system apparatus</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>INCOMPLETE SPINAL CORD INJURY (ASIA D)</condition>
  <arm_group>
    <arm_group_label>4 MIN X 4 MIN HIIT of FES-LCE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 min of high-intensity phase intersperses with 4 min of low-intensity phase for a total of 5 bouts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 MIN X 2 MIN HIIT of FES-LCE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 min of high-intensity phase intersperses with 2 min of low-intensity phase for a total of 10 bouts.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Functional Electrical Stimulation Leg Cycling Exercise</intervention_name>
    <description>FES- leg cycling for 45 minutes (3 min warm up + 40 min HIIT + 2 min cooldown). The FES will be applied via surface electrodes and the stimulation intensity based on your tolerance level.</description>
    <arm_group_label>2 MIN X 2 MIN HIIT of FES-LCE</arm_group_label>
    <arm_group_label>4 MIN X 4 MIN HIIT of FES-LCE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants were diagnosed with incomplete spinal cord injury (SCI) at least one year&#xD;
             prior to participation.&#xD;
&#xD;
          -  Age between 18-75 years old.&#xD;
&#xD;
          -  Both male and female.&#xD;
&#xD;
          -  Have at least 90º bilateral knee flexion.&#xD;
&#xD;
          -  Moderate neurological induce weakness in quadriceps muscle of 1 leg that is responsive&#xD;
             to electrical stimulation (moderate weakness was defined as 3/5 or 4/5 on manual&#xD;
             muscle testing).&#xD;
&#xD;
          -  Able to perform cycling activity.&#xD;
&#xD;
          -  Normal upper limb function.&#xD;
&#xD;
          -  Able to follow command.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Had a recent history of trauma to the lower limb.&#xD;
&#xD;
          -  Severely infected skin pressure sore on weight-bearing skin areas.&#xD;
&#xD;
          -  Illness caused by acute urinary tract infection.&#xD;
&#xD;
          -  Uncontrolled spasticity or pain.&#xD;
&#xD;
          -  History of cardiovascular/cardiorespiratory problem.&#xD;
&#xD;
          -  Orthostatic hypotension.&#xD;
&#xD;
          -  Unhealed decubiti at electrode placement area.&#xD;
&#xD;
          -  Recurrent autonomic dysreflexia.&#xD;
&#xD;
          -  Active heterotopic ossification.&#xD;
&#xD;
          -  Other peripheral or central neurologic injury.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Malaya Medical Center</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>September 5, 2019</last_update_submitted>
  <last_update_submitted_qc>September 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universiti Teknologi Mara</investigator_affiliation>
    <investigator_full_name>MOHD KHAIRUL AZHAR BIN ARIFFIN</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>HIGH INTENSITY INTERVAL TRAINING</keyword>
  <keyword>INCOMPLETE SPINAL CORD INJURY</keyword>
  <keyword>MUSCLE STRENGTH</keyword>
  <keyword>CARDIO-RESPIRATORY FITNESS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT03837834
org study id: 201682-4100
nct id: NCT03837834
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The training consists of 6 weeks of functional electrical stimulation leg cycling exercise
      (FES-LCE) program. The training program comprises of 2 visits per week. Each visit consists
      of FES-LCE for 45 minutes. Throughout the 6 weeks program, there will be testing/assessment
      sessions on week 1, week 3 and week 6. The FES will be applied via surface electrodes and the
      stimulation intensity based on the participant's tolerance level.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes of peak torque of Quadriceps and Hamstring
time frame: Changes of peak torque at 6 week
description: Isometric peak torque for quadriceps and hamstring will be measured using Biodex isokinetic machine.
measure: Changes of peak VO2
time frame: Changes of peak VO2 at 6 week
description: Peak VO2 will be measured using Cosmed Quark CPET system apparatus
arm group label: 4 MIN X 4 MIN HIIT of FES-LCE
arm group type: Experimental
description: 4 min of high-intensity phase intersperses with 4 min of low-intensity phase for a total of 5 bouts.
arm group label: 2 MIN X 2 MIN HIIT of FES-LCE
arm group type: Experimental
description: 2 min of high-intensity phase intersperses with 2 min of low-intensity phase for a total of 10 bouts.
intervention type: Other
intervention name: Functional Electrical Stimulation Leg Cycling Exercise
description: FES- leg cycling for 45 minutes (3 min warm up + 40 min HIIT + 2 min cooldown). The FES will be applied via surface electrodes and the stimulation intensity based on your tolerance level.
arm group label: 2 MIN X 2 MIN HIIT of FES-LCE
arm group label: 4 MIN X 4 MIN HIIT of FES-LCE
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Malaysia
responsible party type: Principal Investigator
investigator affiliation: Universiti Teknologi Mara
investigator full name: MOHD KHAIRUL AZHAR BIN ARIFFIN
investigator title: Principal Investigator
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
sharing ipd: No