Injury of Multiple Muscles and Tendons at Lower Leg LevelNCT04727905
The Effect of Supplementing Different Solutions on Firefighters' Simulated Fire Rescue Training
A study testing energy drink in people with Injury of Multiple Muscles and Tendons at Lower Leg Level, run by National Taiwan Sport University at 1 site in Taiwan.
Trial summary
One of the three major tasks of firefighters is disaster rescue, and fire rescue accounts for the majority. They must wear personal protective equipment (PPE) at the fire site during execution. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Injury of Multiple Muscles and Tendons at Lower Leg Level
- What is being tested?
- energy drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Dec 2020to 30 Dec 2020
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male firefighters aged between 20 and 50
Who cannot join
- cardiovascular disease hypertension metabolic syndrome glucose-6-acid dehydrogenase deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sports Science Institute
One of the three major tasks of firefighters is disaster rescue, and fire rescue accounts for the majority. They must wear personal protective equipment (PPE) at the fire site during execution. This set of equipment plus other equipment required for rescue will always It weighs up to 40 kg, and the rescue environment is extremely hot and the rescue mission must be carried out in a short time. Under this extremely high pressure, firefighters must have speed, agility, strength and endurance that are different from ordinary people. However, after performing the above fire rescue tasks, firefighters often lose a lot of water; therefore, the purpose of this study is to explore the impact of water and electrolyte supplementation on physical recovery after firefighters perform fire rescue tasks. A total of 24 field firefighters from the Fire Department were research subjects.
In the past research on firefighters, there was no research on the effect of water and electrolyte supplementation on physical recovery after dehydration after performing fire rescue tasks. Therefore, in this study, the body composition was measured before and after the special training of firefighters simulated fire rescue. , Collect venous blood; Replenish electrolytes in sections after training, and take venous blood, urine and saliva for tests at 15, 30 and 60 minutes to analyze relevant values and perform strength tests to observe firefighters The state of physical recovery.
The experiment was divided into three groups. The control group only drank 1 liter of pure water, the sports drink group was supplemented with commercially available sports drinks, and the mint flavored sports drink group was supplemented with mint flavored commercially available sports drinks. Drink 1 liter of liquid within 60 minutes after training; 8 people in each of the 3 groups are randomly assigned. The results of the experiment were analyzed by analysis of variance (ANOVA), and Tukey-Kramer test was used to detect whether there are differences between different treatments, and P<0.05 represents statistical significance.
- Being tested
- energy drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
energy drinkDietary supplement
The explosive force and muscle endurance of the lower limbs were tested first, and then the special training intervention for fire rescue was performed. Solution supplementation was carried out. The experiment group was divided into the control group and only drank 1 liter of pure water, and the sports drink group supplemented with commercially available sports drinks (using commercially available treasures). Mineral water powder configuration), mint-flavored sports drink group supplemented with mint-flavored commercially available sports drinks (using commercially available treasure mineral water powder configuration plus edible flavor 0.01% menthol)
| Study group | Role | What they receive |
|---|---|---|
| energy drink | Experimental | Intake after exercise Receives: Dietary Supplement: energy drink |
| Seasoned water | Placebo comparator | Intake after exercise Receives: Dietary Supplement: energy drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood biochemical value
Creatinine
Measured: one day
Blood biochemical value
blood urea nitrogen
Measured: one day
Blood biochemical value
lactate
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start30 Dec 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury of Multiple Muscles and Tendons at Lower Leg LevelStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LinYuChih, National Taiwan Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727905
- Sponsor's protocol ID
- IRB-20-051-A2
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 27 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sports Science Institute
- ClinicalTrials.gov ID
- NCT04727905
- Acronym / sponsor ID
- IRB-20-051-A2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Taiwan Sport UniversityUniversity, hospital or other
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 27 Jan 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.
One of the three major tasks of firefighters is disaster rescue, and fire rescue accounts for the majority. They must wear personal protective equipment (PPE) at the fire site during execution. This set of equipment plus other equipment required for rescue will always It weighs up to 40 kg, and the rescue environment is extremely hot and the rescue mission must be carried out in a short time. Under this extremely high pressure, firefighters must have speed, agility, strength and endurance that are different from ordinary people. However, after performing the above fire rescue tasks, firefighters often lose a lot of water; therefore, the purpose of this study is to explore the impact of water and electrolyte supplementation on physical recovery after firefighters perform fire rescue tasks. A total of 24 field firefighters from the Fire Department were research subjects.
In the past research on firefighters, there was no research on the effect of water and electrolyte supplementation on physical recovery after dehydration after performing fire rescue tasks. Therefore, in this study, the body composition was measured before and after the special training of firefighters simulated fire rescue. , Collect venous blood; Replenish electrolytes in sections after training, and take venous blood, urine and saliva for tests at 15, 30 and 60 minutes to analyze relevant values and perform strength tests to observe firefighters The state of physical recovery.
The experiment was divided into three groups. The control group only drank 1 liter of pure water, the sports drink group was supplemented with commercially available sports drinks, and the mint flavored sports drink group was supplemented with mint flavored commercially available sports drinks. Drink 1 liter of liquid within 60 minutes after training; 8 people in each of the 3 groups are randomly assigned. The results of the experiment were analyzed by analysis of variance (ANOVA), and Tukey-Kramer test was used to detect whether there are differences between different treatments, and P<0.05 represents statistical significance.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| energy drink | Experimental | Dietary Supplement: energy drinkIntake after exercise |
| Seasoned water | Placebo comparator | Dietary Supplement: energy drinkIntake after exercise |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- male firefighters aged between 20 and 50
Key exclusion criteria (1 listed)
- cardiovascular disease hypertension metabolic syndrome glucose-6-acid dehydrogenase deficiency
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 |
|---|---|---|
| energy drinkThe explosive force and muscle endurance of the lower limbs were tested first, and then the special training intervention for fire rescue was performed. Solution supplementation was carried out. The experiment group was divided into the control group and only drank 1 liter of pure water, and the sports drink group supplemented with commercially available sports drinks (using commercially available treasures). Mineral water powder configuration), mint-flavored sports drink group supplemented with mint-flavored commercially available sports drinks (using commercially available treasure mineral water powder configuration plus edible flavor 0.01% menthol) | Dietary supplement | Seasoned water, energy drink |
Primary outcome
Blood biochemical value
Time frame: one day
Creatinine
Blood biochemical value
Time frame: one day
blood urea nitrogen
Blood biochemical value
Time frame: one day
lactate
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 27 Jan 2021.
- Individual participant dataSharing planned: Undecided
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 energy drink in people with Injury of Multiple Muscles and Tendons at Lower Leg Level, run by National Taiwan Sport University at 1 site in Taiwan.
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 1 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 27 Jan 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 Taiwan. 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?
Blood biochemical value (time frame: one day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2021.