Post-exercise Sport StudentsNCT04892784
THE EFFECT OF ACUPUNCTURE ON THE BLOOD LACTIC ACID LEVELS
A study testing Press tack needle acupuncture in people with Post-exercise Sport Students, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Background: In sports, recovery after exercise is a very important process for athletes. Several studies have shown that the rate of disease associated with athlete's recovery can be increased by several modalities, one of which is acupuncture. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Post-exercise Sport Students
- What is being tested?
- Press tack needle acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Dec 2020to 7 Jan 2021
- 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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- willingness to fill out an informed consent form;
- age between 18-25 years;
- male;
- has a BMI value of 18.5-22.9 kg/m2;
- there is no history of injury or history of surgery on the lower extremities in the last three months;
- the individual is in good health.
Who cannot join
- absence or refusal to be examined and not cooperative.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Fakultas Ilmu Keolahragaan Universitas Negeri Jakarta
Jakarta
About this study
Official title: THE EFFECT OF PRESS TACK NEEDLE ACUPUNCTURE ON THE REDUCTION OF POST-EXERCISE BLOOD LACTIC ACID LEVELS IN SPORT STUDENTS
Background: In sports, recovery after exercise is a very important process for athletes. Several studies have shown that the rate of disease associated with athlete's recovery can be increased by several modalities, one of which is acupuncture.
Objectives: The purpose of this study was to see how the effect of press tack needle acupuncture in reducing blood lactic acid levels after exercise in sports students.
Methods: The study design was a randomized controlled clinical trial. Twenty-four sport students were divided into two groups: the acupuncture group (n = 12) and the normal group (n = 12). Press tack needle was attached on PC6 Neiguan and ST36 Zusanli 30 minutes before doing high-intensity exercise. Measurement of lactic acid levels was carried out at 5 minutes and 30 minutes after exercise.
- Conditions
- Post-exercise Sport Students
- Being tested
- Press tack needle acupuncture
- Keywords
- acupuncture, lactic acid levels, post-exercise recovery, press tack needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Press tack needle acupunctureDevice
Pyonex press tack needle sized 0.20x1.2mm
| Study group | Role | What they receive |
|---|---|---|
| Press tack needle acupuncture | Experimental | Not described Receives: Device: Press tack needle acupuncture |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactic acid levels
Mean difference of lactic acid levels between two groups
Measured: 5-minute after physical exercise and 30-minute after physical exercise
Secondary outcomes (1)
Heart rate
Mean difference of heart rate between two group
Measured: 0-minute after physical exercise and 30-minute after physical exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start15 Dec 2020
- Primary completion28 Dec 2020
- Study completion7 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-exercise Sport StudentsStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wahyuningsih Djaali, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892784
- Sponsor's protocol ID
- 2011-1390
- Status last verified
- Aug 2021
- First submitted
- 11 May 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Djaali W, Mighra BA, Nurdin F, Setiakarnawijaya Y. Press-Tack Needle Acupuncture Reduces Postexercise Blood Lactic-Acid Levels in Sports Students. Med Acupunct. 2023 Oct 1;35(5):246-250. doi: 10.1089/acu.2023.0003. Epub 2023 Oct 17.
PubMed 37920859
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF PRESS TACK NEEDLE ACUPUNCTURE ON THE REDUCTION OF POST-EXERCISE BLOOD LACTIC ACID LEVELS IN SPORT STUDENTS
- ClinicalTrials.gov ID
- NCT04892784
- Acronym / sponsor ID
- 2011-1390
- Conditions
- Post-exercise Sport Students
- Keywords
- acupuncture, lactic acid levels, post-exercise recovery, press tack needle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 28 Dec 2020 (actual)
- Study completion
- 7 Jan 2021 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: In sports, recovery after exercise is a very important process for athletes. Several studies have shown that the rate of disease associated with athlete's recovery can be increased by several modalities, one of which is acupuncture.
Objectives: The purpose of this study was to see how the effect of press tack needle acupuncture in reducing blood lactic acid levels after exercise in sports students.
Methods: The study design was a randomized controlled clinical trial. Twenty-four sport students were divided into two groups: the acupuncture group (n = 12) and the normal group (n = 12). Press tack needle was attached on PC6 Neiguan and ST36 Zusanli 30 minutes before doing high-intensity exercise. Measurement of lactic acid levels was carried out at 5 minutes and 30 minutes after exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Press tack needle acupuncture | Experimental | Device: Press tack needle acupuncture |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- willingness to fill out an informed consent form;
- age between 18-25 years;
- male;
- has a BMI value of 18.5-22.9 kg/m2;
- there is no history of injury or history of surgery on the lower extremities in the last three months;
Key exclusion criteria (1 listed)
- absence or refusal to be examined and not cooperative.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Press tack needle acupuncturePyonex press tack needle sized 0.20x1.2mm | Device | Press tack needle acupuncture |
Primary outcome
Lactic acid levels
Time frame: 5-minute after physical exercise and 30-minute after physical exercise
Mean difference of lactic acid levels between two groups
1 secondary outcome
Heart rate
Time frame: 0-minute after physical exercise and 30-minute after physical exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Derived from this study: PubMed 37920859Djaali W, Mighra BA, Nurdin F, Setiakarnawijaya Y. Press-Tack Needle Acupuncture Reduces Postexercise Blood Lactic-Acid Levels in Sports Students. Med Acupunct. 2023 Oct 1;35(5):246-250. doi: 10.1089/acu.2023.0003. Epub 2023 Oct 17.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Press tack needle acupuncture in people with Post-exercise Sport Students, 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 6 inclusion and 1 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 30 Aug 2021. 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. 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?
Lactic acid levels (time frame: 5-minute after physical exercise and 30-minute after physical exercise). 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 NCT04892784, which also lists 1 linked publication.
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 30 Aug 2021.