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Sports Physical TherapysportacupNCT06708312

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

A study testing press needle acupuncture in people with Sports Physical Therapy and Military Activity, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 20 yearsHealthy volunteers can take part
What is being tested?
press needle acupuncture
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
1 siteIndonesia
Study dates
15 Nov 2024to 15 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Indonesia Defence University

    Bogor, West Java, 16810

Other trials in Indonesia

About this study

Official title: The Effect Of Ears Acupuncture On Fitness Test 12 Minute Running Students Of Medical Faculty UNHAN RI Third Semester

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.

Being tested
press needle acupuncture, sham press needle acupuncture
Keywords
12 minutes running test, ear acupuncture, sport endurance
Medical subject headings
Overtraining Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • press needle acupunctureProcedure or surgery

    Also called ear acupuncture, earlobe acupuncture

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

  • sham press needle acupunctureProcedure or surgery

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

Study groups in NCT06708312
Study groupRoleWhat they receive
ear acupunctureExperimentalPlacement 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
Receives: Procedure: press needle acupuncture
sham ear acupunctureSham comparatorPlacement 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.
Receives: Procedure: sham press needle acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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.

    Measured: 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

    Measured: 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%

    Measured: 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."

    Measured: 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

    Measured: 5, 10, 15 minutes after running test

Secondary outcomes (1)

  1. Adverse event

    Symptoms reported by patients after receiving press needle acupuncture

    Measured: immediately after and follow up 1 week after running session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2024
  2. Study start15 Nov 2024
  3. Primary completion15 Jan 2025
  4. Study completion15 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
intervention group : ear acupuncture control group : sham ear acupuncture
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06708312
Sponsor's protocol ID
24-09-1517
Acronym
sportacup
Status last verified
May 2025
First submitted
24 Nov 2024
Last updated
22 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: via the clinicaltrial.org

Questions about this trial

What is this clinical trial studying?

A study testing press needle acupuncture in people with Sports Physical Therapy and Military Activity, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VO2 max prediction scores (time frame: 5, 10, 15 minutes after running sessions). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06708312.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.

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