<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/NCT03821805</url>
  </required_header>
  <id_info>
    <org_study_id>UT-IRB-2016-017</org_study_id>
    <nct_id>NCT03821805</nct_id>
  </id_info>
  <brief_title>Acute Effect of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform</brief_title>
  <official_title>Effects of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform After Yo Yo Intermittent Recovery Test and Repeated Sprint Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Taipei</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Taipei</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>
      Foot reflexology treatment provides acute and chronic effects on cardiovascular and&#xD;
      hemodynamic functions. However, no information is available to us in regarding the treatment&#xD;
      effect of foot reflexology after exercise. This study investigated the acute effect of foot&#xD;
      reflexology treatment on heart rate variability after anaerobic-based and aerobic-based&#xD;
      intermittent exercises.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The sympathetic activation and sympathy-vagal balance after repeat sprint performance can be&#xD;
      immediately modulated by foot reflexology massage. The acute benefits of foot reflexology&#xD;
      intervention on cardiac sympathovagal balance can be considered as exercise recovery&#xD;
      strategies in sports.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 22, 2016</start_date>
  <completion_date type="Actual">June 13, 2017</completion_date>
  <primary_completion_date type="Actual">June 13, 2017</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>immediately following intervention phase</time_frame>
    <description>15 minutes resting electrocardiographic record at baseline and post-intervention phase</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arterial pulse waveform</measure>
    <time_frame>immediately following intervention phase</time_frame>
    <description>15 minutes resting arterial plethysmographic waveform at baseline and post-intervention phase</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Massage</condition>
  <condition>Anaerobic Exercise</condition>
  <condition>Aerobic Exercise</condition>
  <arm_group>
    <arm_group_label>Foot reflexology massage group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The duration of intervention was 30 min (15 min massage duration for each leg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Rest for 30 min</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Foot reflexology massage</intervention_name>
    <description>Foot reflexology technique of Father Josef was used as massage intervention</description>
    <arm_group_label>Foot reflexology massage group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undertake football/futsal training at least 3 times a week&#xD;
&#xD;
          -  Age between 18 and 30 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of severe neuromuscular injury&#xD;
&#xD;
          -  Current lower extremity injury&#xD;
&#xD;
          -  Current neurological diseases&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 26, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 26, 2019</last_update_submitted>
  <last_update_submitted_qc>January 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Taipei</investigator_affiliation>
    <investigator_full_name>YUNG-SHENG CHEN</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Heart rate variability</keyword>
  <keyword>Arterial pulse waveform</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data is protected by IRB application with a minimum of 3 years data storage.</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/NCT03821805
org study id: UT-IRB-2016-017
nct id: NCT03821805
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Foot reflexology treatment provides acute and chronic effects on cardiovascular and
      hemodynamic functions. However, no information is available to us in regarding the treatment
      effect of foot reflexology after exercise. This study investigated the acute effect of foot
      reflexology treatment on heart rate variability after anaerobic-based and aerobic-based
      intermittent exercises.
The sympathetic activation and sympathy-vagal balance after repeat sprint performance can be
      immediately modulated by foot reflexology massage. The acute benefits of foot reflexology
      intervention on cardiac sympathovagal balance can be considered as exercise recovery
      strategies in sports.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Heart rate variability
time frame: immediately following intervention phase
description: 15 minutes resting electrocardiographic record at baseline and post-intervention phase
measure: Arterial pulse waveform
time frame: immediately following intervention phase
description: 15 minutes resting arterial plethysmographic waveform at baseline and post-intervention phase
arm group label: Foot reflexology massage group
arm group type: Experimental
description: The duration of intervention was 30 min (15 min massage duration for each leg)
arm group label: Control group
arm group type: No Intervention
description: Rest for 30 min
intervention type: Other
intervention name: Foot reflexology massage
description: Foot reflexology technique of Father Josef was used as massage intervention
arm group label: Foot reflexology massage group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Taipei
investigator full name: YUNG-SHENG CHEN
investigator title: Associate Professor
sharing ipd: No
ipd description: Individual participant data is protected by IRB application with a minimum of 3 years data storage.