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

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

Tracking Information

• First Submitted Date: January 22, 2019
• First Posted Date: January 30, 2019
• Last Update Posted Date: January 30, 2019
• Actual Study Start Date: December 22, 2016
• Actual Primary Completion Date: June 13, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Acute Effect of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science

Condition

• Massage
• Anaerobic Exercise
• Aerobic Exercise

Intervention

Other: Foot reflexology massage

Foot reflexology technique of Father Josef was used as massage intervention

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 26, 2019): 28
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 13, 2017
• Actual Primary Completion Date: June 13, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Male

• Ages: 18 Years to 30 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03821805
• Other Study ID Numbers: 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

• 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: University of Taipei
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Taipei
• Verification Date: January 2019