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CompletedNCT06708312sportacupUpdated May 22, 2025

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

An interventional study of press needle acupuncture and sham press needle acupuncture in Sports Physical Therapy, Military Activity and Exercise Overtraining, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by Indonesia University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years to 20 Years
Sex
All
01

Study 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.

Read the detailed description

Ear acupuncture is a affordable, easy and non-invasive method with good evidence of effectiveness in the scope of physical training. Several previous studies has proven the effectiveness of acupuncture in physical exercise, including helping increases oxygen absorption and reduces lactic acid after exercise, lowering chronic musculoskeletal pain. In reducing pain after physical activity, ear acupuncture has been shown to reduce VAS leg intensity. This shows that ear acupuncture can helps athletes recover after intense training faster. At the Defense University of the Republic of Indonesia (UNHAN RI), Study Program students Bachelor of Medicine (cadet) has both academic demands and military training. The military education demands high stamina and physical fitness. To make sure the cadets are in a fit condition to face daily activities with a busy and numerous schedule physical activity, a physical fitness assessment is carried out at the end of each semester using the 12 run test. By doing this test, principal investigator aims to observe the effect of giving ear press needle acupuncture compare with sham on running 12 minutes in Indonesian Defense University student of medical faculty.

02

Conditions studied

  • Sports Physical Therapy
  • Military Activity
  • Exercise Overtraining

Keywords

  • 12 minutes running test
  • ear acupuncture
  • sport endurance
03

In context

Lead sponsor

Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    ear acupuncture

    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 comparator
    sham ear acupuncture

    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

  • Procedurepress needle acupuncture

    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

  • Proceduresham press needle acupuncture

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 5, 10, 15 minutes after running sessions

  2. 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.

    Time frame: 5, 10, 15 minutes after running sessions

  3. 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

    Time frame: 5, 10, 15 minutes after running test

  4. 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%

    Time frame: after running test, before and after intervention and sham

  5. 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."

    Time frame: 5, 10 , 15 minutes after running test

  6. 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

    Time frame: 5, 10, 15 minutes after running test

Secondary outcomes

  1. Adverse event

    Symptoms reported by patients after receiving press needle acupuncture

    Time frame: immediately after and follow up 1 week after running session

07

Study locations

1 site
  • Indonesia Defence University
    Bogor, West Java 16810, Indonesia
08

References and documents

Individual participant data

Plan to share: Yes — via the clinicaltrial.org

Supporting information: Study protocol, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06708312
Lead sponsor
Indonesia University
Responsible party
Elies Fitriani (MD, Indonesia University) — Principal investigator
First posted
Nov 27, 2024
Start date
Nov 15, 2024
Primary completion
Jan 15, 2025
Completion
Jan 15, 2025
Last update
May 22, 2025

Study contacts

KPEK FKUI-RSCM The Health Research Ethic Comittee of Faculty of Medicine
principal investigator · Indonesia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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