The Effect Of Ears Acupuncture On Fitness Test 12 Minutes Running in Students Of Medical Faculty UNHAN RI

NCT06708312 | Completed DMC

• 1 other identifier: 24-09-1517
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to study the use of ear acupuncture in 12 minutes running test on third semester of cadets of Medical Faculty, Indonesia Defense University, between intervention and sham group. The outcome measure are heart rate, blood pressure, running distance, intensity and VAS RPE also VAS leg intensity.

Conditions

Sports Physical Therapy; Military Activity; Exercise Overtraining

Keywords

12 minutes running test; ear acupuncture; sport endurance

Outcome Measures

Primary Outcomes (6)

• VO2 max prediction scores

  Reference maximum amount individual capacity in use oxygen during doing activities or exercising, using VO2max prediction scores based on running distance (in meters), then entered into formula (mileage - 504.9 meters)/44.73 and categorized into : * Very good * OK * Enough * Less * Very less

  5, 10, 15 minutes after running sessions

• Blood pressure

  The pressure that occurs on arterial blood vessels when blood is pumped by the heart to be distributed throughout body, units of millimeters of water mercury(mmHg), measured with digital blood pressure meter.

  5, 10, 15 minutes after running sessions

• Pulse beat

  A palpable wave in the arteries when blood is pumped out the heart, reflecting heart rate, counted each the minutes count repetitions (times/min), measurement using digital smart watch

  5, 10, 15 minutes after running test

• Exercise intensity

  The power of deep stimulation exercise, for aerobic exercise heart rate is used. Intensity is categorized in zone, in this study used heavy intensity and maximum 77-100% of HRmax. Measured by Heart rate peak entered into formula Heart rate peak divide into Heart rate maximum x 100%

  after running test, before and after intervention and sham

• The Borg rating scale/RPE

  The Borg Rating of Perceived Exertion ('Borg' or 'RPE') is a scale used as a indicators to determine energy exerted in a workout with a range 6-20, where 6 means "no exertion at all" and 20 means "maximal exertion."

  5, 10 , 15 minutes after running test

• Modifid borg scale leg fatigue

  Modified Borg scale to determine size exertion in terms of this is the maximum strength of the leg (inferior extremity) in running with a range of 0-10.0 scale minimum and 10 represents maximum power possible someone tolerates

  5, 10, 15 minutes after running test

Secondary Outcomes (1)

• Adverse event

  immediately after and follow up 1 week after running session

Study Arms (2)

ear acupuncture

EXPERIMENTAL

Placement of pressure needles on the MA-TF1 Shenmen, MA-IC4 Heart and ear points MA-IC4 Sympathetic is carried out 30 minutes before starting the running session. Aseptic and antiseptic measures are carried out with alcohol wipe. Stimulation is carried out at the acupuncture points determined by press for 1 minute, using a press needle measuring 0.22 mm x 15 mm. Press the needle removed 15 minutes after the run

Procedure: press needle acupuncture

sham ear acupuncture

SHAM COMPARATOR

Placement of adhesive plaster on the MA-TF1 Shenmen, MA-IC4 Heart ear points and MA-IC4 Sympathetic is carried out 30 minutes before starting the running session. Aseptic and antiseptic measures are carried out with alcohol swab. At acupuncture points, pressure stimulation is not carried out, only rubbing. The adhesive plaster is removed 15 minutes after running.

Procedure: sham press needle acupuncture

Interventions

press needle acupuncture PROCEDURE

Placement of press needle on the ear acupuncture point : MA-TF1 Shenmen, MA-IC4 Heart, and MA-IC4 Sympathetic

Also known as: ear acupuncture, earlobe acupuncture

ear acupuncture

sham press needle acupuncture PROCEDURE

Placement of adhesive plaster on the ear acupuncture point : MA-TF1 Shenmen, MA-IC4 Heart, and MA-IC4 Sympathetic

sham ear acupuncture

Eligibility Criteria

• Age: 18 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Indonesian Defense University Military FK Student Batch 4, Third semester
• Gender male or female, age 18-20 years
• Physically healthy based on the results of medical check-ups in the last 6 months mini medical check up (blood pressure, pulse, saturation, glucose and, Hb check carried out by researchers) as well as being eligible for physical exercise, assessed by PAR-Q questionnaire, history and physical examination
• Willing to follow this research until completion and sign informed consent.
• BMI is normal
• Regularly exercise 5x a week with moderate to heavy intensity categories good physical fitness level
• Do not consume caffeine and high calorie foods high in sugar for 1 hour before the test run

You may not qualify if:

• Taking anti-inflammatory drugs (corticosteroids), anti pain (NSAIDS, opioids), muscle relaxants (diazepam, eperisone, etc.) or taking blood thinning drugs (anti-platelet or anti-coagulant drugs).
• Have received any type of acupuncture therapy for some time \<7 days before the study.
• History of anti-inflammatory drug treatment in the previous 2 weeks.
• There are tumors, wounds or skin infections, eczema, otitis externa and psoriasis in matchmaking area.
• There was a hypersensitivity reaction to previous acupuncture therapy (allergy metals, severe atopy, keloids, or other skin hypersensitivity).
• Participants had multiple ear piercings.
• Have had surgery on the waist, hip, knee and ankle area before last 1 year.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Indonesia Defence University

Bogor, West Java, 16810, Indonesia

Location

MeSH Terms

Conditions

Overtraining Syndrome

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Officials

• KPEK FKUI-RSCM The Health Research Ethic Comittee of Faculty of Medicine

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participant blinding by divide into two group randomly and received true ear acupuncture or sham acupuncture randomization were done by research assistant outcome assesed by research assistant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: intervention group : ear acupuncture control group : sham ear acupuncture

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: November 27, 2024
• Study Start: November 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: during this research start november 15th 2024, end november, 15th 2025

Locations

ID (1)