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临床试验/NCT06708312
NCT06708312已完成不适用

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

Indonesia University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2024年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
1
主要终点
VO2 max prediction scores

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 20 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

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

干预措施: press needle acupuncture (Procedure)

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.

干预措施: sham press needle acupuncture (Procedure)

结局指标

主要结局

VO2 max prediction scores

时间窗: 5, 10, 15 minutes after running sessions

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

Blood pressure

时间窗: 5, 10, 15 minutes after running sessions

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.

Pulse beat

时间窗: 5, 10, 15 minutes after running test

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

Exercise intensity

时间窗: after running test, before and after intervention and sham

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%

The Borg rating scale/RPE

时间窗: 5, 10 , 15 minutes after running test

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."

Modifid borg scale leg fatigue

时间窗: 5, 10, 15 minutes after running test

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

次要结局

  • Adverse event(immediately after and follow up 1 week after running session)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elies Fitriani

MD

Indonesia University

研究点 (1)

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