Clinical trial NCT06708312: The Effect Of Ears Acupuncture On Fitness Test 12 Minutes Running in Students Of Medical Faculty UNHAN RI
Official title: The Effect Of Ears Acupuncture On Fitness Test 12 Minute Running Students Of Medical Faculty UNHAN RI Third Semester
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Physical Therapy
Military Activity
Exercise Overtraining
Keywords: 12 minutes running test
ear acupuncture
sport endurance
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention group : ear acupuncture control group : sham ear acupuncture
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: VO2 max prediction scores
timeFrame: 5, 10, 15 minutes after running sessions
measure: Blood pressure
timeFrame: 5, 10, 15 minutes after running sessions
measure: Pulse beat
timeFrame: 5, 10, 15 minutes after running test
measure: Exercise intensity
timeFrame: after running test, before and after intervention and sham
measure: The Borg rating scale/RPE
timeFrame: 5, 10 , 15 minutes after running test
measure: Modifid borg scale leg fatigue
timeFrame: 5, 10, 15 minutes after running test
Secondary outcomes:
measure: Adverse event
timeFrame: immediately after and follow up 1 week after running session
Other outcomes:
Locations:
city: Bogor
country: Indonesia
facility: Indonesia Defence University
state: West Java
Study officials:
affiliation: Indonesia University
name: KPEK FKUI-RSCM The Health Research Ethic Comittee of Faculty of Medicine
role: PRINCIPAL_INVESTIGATOR
References: