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Acute Effect of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform

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ClinicalTrials.gov Identifier: NCT03821805
Recruitment Status : Completed
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
YUNG-SHENG CHEN, University of Taipei

Tracking Information
First Submitted Date  ICMJE January 22, 2019
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date January 30, 2019
Actual Study Start Date  ICMJE December 22, 2016
Actual Primary Completion Date June 13, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2019)
Heart rate variability [ Time Frame: immediately following intervention phase ]
15 minutes resting electrocardiographic record at baseline and post-intervention phase
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2019)
Arterial pulse waveform [ Time Frame: immediately following intervention phase ]
15 minutes resting arterial plethysmographic waveform at baseline and post-intervention phase
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Effect of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform
Official Title  ICMJE Effects of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform After Yo Yo Intermittent Recovery Test and Repeated Sprint Test
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Massage
  • Anaerobic Exercise
  • Aerobic Exercise
Intervention  ICMJE Other: Foot reflexology massage
Foot reflexology technique of Father Josef was used as massage intervention
Study Arms  ICMJE
  • Experimental: Foot reflexology massage group
    The duration of intervention was 30 min (15 min massage duration for each leg)
    Intervention: Other: Foot reflexology massage
  • No Intervention: Control group
    Rest for 30 min
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2019)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 13, 2017
Actual Primary Completion Date June 13, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Undertake football/futsal training at least 3 times a week
  • Age between 18 and 30 years old

Exclusion Criteria:

  • History of severe neuromuscular injury
  • Current lower extremity injury
  • Current neurological diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03821805
Other Study ID Numbers  ICMJE UT-IRB-2016-017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual participant data is protected by IRB application with a minimum of 3 years data storage.
Responsible Party YUNG-SHENG CHEN, University of Taipei
Study Sponsor  ICMJE University of Taipei
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Taipei
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP