Body Weight ChangesNCT06543017
Pre Competition Weight Loss of Athletes
A study testing Experimental group in people with Body Weight Changes, run by Chengdu Sport University at 1 site in China.
Trial summary
The objective of this observational study is to assess the long-term impact of a combined slow and rapid weight reduction strategy on the physiological performance, mental state, and sleep quality of male freestyle wrestlers. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2024to 3 May 2024
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be male freestyle wrestlers aged 18 years or older
- Athletes should be preparing for the 2024 Chinese Wrestling Championships
- Individuals must be willing to undergo all tests and assessments at the three specified time points (T1, T2, T3) over the 38-day study period
- Participants should be in good health, with no medical conditions that would prevent them from completing the study
- Athletes must be undergoing a combined slow and rapid weight reduction strategy as part of their regular training regimen
Who cannot join
- Individuals with a history of severe cardiovascular, metabolic, or endocrine disorders that could affect the study outcomes
- Wrestlers who are unable to comply with the study's testing schedule or intervention protocols
- Participants with any condition that would make them unsuitable for the anaerobic power testing or blood sampling
- Wrestlers who are unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Physiological Performance, Psychological State, and Sleep Quality of Athletes From Sichuan Province, China During the Pre Competition Weight Loss Stage
The objective of this observational study is to assess the long-term impact of a combined slow and rapid weight reduction strategy on the physiological performance, mental state, and sleep quality of male freestyle wrestlers. The primary question it seeks to address is:
Does the combined weight reduction approach affect the physiological performance, mental state, and sleep quality of male freestyle wrestlers during the pre-competition period?
Participants will undergo tests at three stages of their weight reduction process (T1, T2, T3) over a period of 38 days prior to the competition, providing data on various physiological and psychological indicators.
Read the detailed description
The goal of this observational study is to investigate the long-term effects of a combined slow and rapid weight reduction strategy on the physiological performance, mental state, and sleep quality of male freestyle wrestlers over the period leading up to a competition. The main question it aims to answer is:
Does the combined weight reduction approach affect the physiological performance, mental state, and sleep quality of male freestyle wrestlers when implemented during the pre-competition phase?
Participants, who are already undergoing this weight reduction strategy as part of their regular training regimen for the 2024 Chinese Wrestling Championships, will be assessed at three distinct time points over a 38-day period. The study will involve the following detailed procedures:
Participant Selection: The study includes 16 male freestyle wrestlers from Sichuan Province, China, with an average age of 20.2 years, and extensive competitive experience.
Study Duration: The observation period spans 38 days prior to the competition, divided into a 30-day slow weight reduction phase and a 7-day rapid weight reduction phase, with the final assessment conducted the day before the competition.
Data Collection: Participants will undergo a series of tests at three time points (T1, T2, T3):
T1: First day of slow weight reduction. T2: First day of rapid weight reduction. T3: The day before the competition.
Testing Indicators:
Physiological performance will be measured through heart rate, blood pressure, blood tests for markers like creatine kinase, testosterone, and immunoglobulin G, body composition analysis, and anaerobic power testing.
Mental state will be evaluated using the Profile of Mood States questionnaire, assessing mood dimensions such as tension, anger, fatigue, depression, energy, confusion, and self-esteem.
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, a questionnaire that evaluates sleep quality over the past month.
Data Analysis: The study will analyze changes in physiological performance, mental state, and sleep quality from T1 to T3, looking for significant differences that may indicate the impact of the weight reduction strategy.
Ethical Considerations: The study is approved by the Ethics Committee for Human Experiments at Sichuan Sports College and adheres to the Declaration of Helsinki. All participants provide informed consent.
Study Hypothesis: There will be significant differences in the changes in physiological performance, mental state, and sleep quality of male freestyle wrestlers during the pre-competition slow and rapid weight reduction training period.
- Conditions
- Body Weight Changes
- Being tested
- Experimental group
- Keywords
- wrestling, weight reduction, physiological performance, mental state, sleep quality
- Medical subject headings
- Body Weight Changes, Weight Loss, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
This study included 16 male freestyle wrestlers from Sichuan Province, China. Participants were tested at three time points: the first day of slow weight reduction (T1), the first day of rapid weight reduction (T2), and the day before competition (T3), with measurements taken for physiological performance, mental state, and sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | A total of three tests were conducted on all participants, each time between 6:00 and 9:00 in the morning. The first test (first day of slow weight reduction, T1) was on 26th March, the second test (first day of rapid weight reduction, T2) was on 26th April, and the third test (the day before the competition, T3) was on 3rd May. Receives: Other: Experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Testing
Participants' blood pressure were measured in a supine position using an instrument (manufactured in Shenzhen, China, model: CK-W355) by laboratory personnel, with the average of three readings taken.
Measured: 38 days
Serum testosterone
Approximately 3 mL of antecubital venous blood was collected from participants and tested for serum testosterone.
Measured: 38 days
Serum creatine kinase
Approximately 3 mL of antecubital venous blood was collected from participants and tested for serum creatine kinase.
Measured: 38 days
Serum blood urea
Approximately 3 mL of antecubital venous blood was collected from participants and tested for serum blood urea.
Measured: 38 days
Serum immunoglobulin G
Approximately 3 mL of antecubital venous blood was collected from participants and tested for serum immunoglobulin G.
Measured: 38 days
Serum immunoglobulin A
Approximately 3 mL of antecubital venous blood was collected from participants and tested for serum immunoglobulin A.
Measured: 38 days
Serum immunoglobulin M
Approximately 3 mL of antecubital venous blood was collected from participants and tested for serum immunoglobulin M.
Measured: 38 days
Body Composition Testing
The participants' weight and body fat percentage were tested using the Korean INBODY 3.0.
Measured: 38 days
The Profile of Mood States
For psychological state: the Profile of Mood States, a tool for studying mood states and their relation to exercise performance, was used. Participants answered 40 questions with a five-point scale (0 to 4 points, with 0 indicating 'almost none', 1 'a little', 2 'moderate', 3 'quite a bit', and 4 'extremely'), including seven mood dimensions: tension, anger, fatigue, depression, energy, confusion, and self-esteem. Energy and self-esteem are positive mood dimensions, with higher scores indicating better mood states, while the other five are negative mood dimensions, with higher scores indicating worse mood states. The total score, total mood disturbance (calculated as the sum of the five negative mood scores minus the sum of the two positive mood scores plus 100), indicates worse mood states with higher scores. The scale has a reliability between 0.60 and 0.82 and a validity greater than 0.90 for Chinese individuals.
Measured: 38 days
Sleep quality
The pittsburgh sleep quality index, a questionnaire for assessing sleep quality over the past month, consists of 18 self-rated items forming seven components, with a total score ranging from 0 to 21, where higher scores indicate worse sleep quality. The scale has a reliability between 0.65 and 0.84 and a validity greater than 0.85 for Chinese individuals.
Measured: 38 days
Anaerobic Power Testing
The Wingate 30-second anaerobic test (MONARK 894E, MONARK Company, Sweden) was used. Participants pedalled as fast as possible, adjusting to the prescribed resistance load within 3 to 4 seconds, and started timing for a 30-second all-out cycling exercise. The average power over 30 seconds, total work output, maximum power output within 5 seconds, and minimum power output within 5 seconds were recorded.
Measured: 38 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start26 Mar 2024
- Primary completion2 May 2024
- Study completion3 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The participates of the study were 16 male freestyle wrestlers from Sichuan Province, China, preparing for the 2024 Chinese Wrestling Championships (4th to 12th May 2024). Based on their competition categories, they were to participate in five weight classes (57, 61, 65, 70, and 74 kg), with a total of 16 individuals (four in the 70 kg class, and three per other class). The study period was 38 days prior to the competition. Based on the training schedule and weight reduction characteristics, it was divided into a slow weight reduction phase (where athletes reduced weight slowly by adjusting their dietary structure and increasing the volume of aerobic exercise) and a rapid weight reduction phase (where athletes achieved rapid weight loss by further restricting water intake and adjusting their diet).
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Liang, Chengdu Sport University
- Investigators
- Xiong Weizhi, Dr, Study chair, Chengdu Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543017
- Sponsor's protocol ID
- SSC2024
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Physiological Performance, Psychological State, and Sleep Quality of Athletes From Sichuan Province, China During the Pre Competition Weight Loss Stage
- ClinicalTrials.gov ID
- NCT06543017
- Acronym / sponsor ID
- SSC2024
- Conditions
- Body Weight Changes
- Keywords
- wrestling, weight reduction, physiological performance, mental state, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chengdu Sport UniversityUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 7 Aug 2024 (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.
The objective of this observational study is to assess the long-term impact of a combined slow and rapid weight reduction strategy on the physiological performance, mental state, and sleep quality of male freestyle wrestlers. The primary question it seeks to address is:
Does the combined weight reduction approach affect the physiological performance, mental state, and sleep quality of male freestyle wrestlers during the pre-competition period?
Participants will undergo tests at three stages of their weight reduction process (T1, T2, T3) over a period of 38 days prior to the competition, providing data on various physiological and psychological indicators.
Detailed description
The goal of this observational study is to investigate the long-term effects of a combined slow and rapid weight reduction strategy on the physiological performance, mental state, and sleep quality of male freestyle wrestlers over the period leading up to a competition. The main question it aims to answer is:
Does the combined weight reduction approach affect the physiological performance, mental state, and sleep quality of male freestyle wrestlers when implemented during the pre-competition phase?
Participants, who are already undergoing this weight reduction strategy as part of their regular training regimen for the 2024 Chinese Wrestling Championships, will be assessed at three distinct time points over a 38-day period. The study will involve the following detailed procedures:
Participant Selection: The study includes 16 male freestyle wrestlers from Sichuan Province, China, with an average age of 20.2 years, and extensive competitive experience.
Study Duration: The observation period spans 38 days prior to the competition, divided into a 30-day slow weight reduction phase and a 7-day rapid weight reduction phase, with the final assessment conducted the day before the competition.
Data Collection: Participants will undergo a series of tests at three time points (T1, T2, T3):
T1: First day of slow weight reduction. T2: First day of rapid weight reduction. T3: The day before the competition.
Testing Indicators:
Physiological performance will be measured through heart rate, blood pressure, blood tests for markers like creatine kinase, testosterone, and immunoglobulin G, body composition analysis, and anaerobic power testing.
Mental state will be evaluated using the Profile of Mood States questionnaire, assessing mood dimensions such as tension, anger, fatigue, depression, energy, confusion, and self-esteem.
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, a questionnaire that evaluates sleep quality over the past month.
Data Analysis: The study will analyze changes in physiological performance, mental state, and sleep quality from T1 to T3, looking for significant differences that may indicate the impact of the weight reduction strategy.
Ethical Considerations: The study is approved by the Ethics Committee for Human Experiments at Sichuan Sports College and adheres to the Declaration of Helsinki. All participants provide informed consent.
Study Hypothesis: There will be significant differences in the changes in physiological performance, mental state, and sleep quality of male freestyle wrestlers during the pre-competition slow and rapid weight reduction training period.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The participates of the study were 16 male freestyle wrestlers from Sichuan Province, China, preparing for the 2024 Chinese Wrestling Championships (4th to 12th May 2024). Based on their competition categories, they were to participate in five weight classes (57, 61, 65, 70, and 74 kg), with a total of 16 individuals (four in the 70 kg class, and three per other class). The study period was 38 days prior to the competition. Based on the training schedule and weight reduction characteristics, it was divided into a slow weight reduction phase (where athletes reduced weight slowly by adjusting their dietary structure and increasing the volume of aerobic exercise) and a rapid weight reduction phase (where athletes achieved rapid weight loss by further restricting water intake and adjusting their diet).
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Experimental groupA total of three tests were conducted on all participants, each time between 6:00 and 9:00 in the morning. The first test (first day of slow weight reduction, T1) was on 26th March, the second test (first day of rapid weight reduction, T2) was on 26th April, and the third test (the day before the competition, T3) was on 3rd May. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants must be male freestyle wrestlers aged 18 years or older
- Athletes should be preparing for the 2024 Chinese Wrestling Championships
- Individuals must be willing to undergo all tests and assessments at the three specified time points (T1, T2, T3) over the 38-day study period
- Participants should be in good health, with no medical conditions that would prevent them from completing the study
- Athletes must be undergoing a combined slow and rapid weight reduction strategy as part of their regular training regimen
Key exclusion criteria (4 listed)
- Individuals with a history of severe cardiovascular, metabolic, or endocrine disorders that could affect the study outcomes
- Wrestlers who are unable to comply with the study's testing schedule or intervention protocols
- Participants with any condition that would make them unsuitable for the anaerobic power testing or blood sampling
- Wrestlers who are unwilling or unable to provide informed consent
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 |
|---|---|---|
| Experimental groupThis study included 16 male freestyle wrestlers from Sichuan Province, China. Participants were tested at three time points: the first day of slow weight reduction (T1), the first day of rapid weight reduction (T2), and the day before competition (T3), with measurements taken for physiological performance, mental state, and sleep quality. | Other | Experimental group |
Primary outcome
Blood Pressure Testing
Time frame: 38 days
Participants' blood pressure were measured in a supine position using an instrument (manufactured in Shenzhen, China, model: CK-W355) by laboratory personnel, with the average of three readings taken.
Serum testosterone
Time frame: 38 days
Approximately 3 mL of antecubital venous blood was collected from participants and tested for serum testosterone.
Serum creatine kinase
Time frame: 38 days
Approximately 3 mL of antecubital venous blood was collected from participants and tested for serum creatine kinase.
Serum blood urea
Time frame: 38 days
Approximately 3 mL of antecubital venous blood was collected from participants and tested for serum blood urea.
Serum immunoglobulin G
Time frame: 38 days
Approximately 3 mL of antecubital venous blood was collected from participants and tested for serum immunoglobulin G.
Serum immunoglobulin A
Time frame: 38 days
Approximately 3 mL of antecubital venous blood was collected from participants and tested for serum immunoglobulin A.
Serum immunoglobulin M
Time frame: 38 days
Approximately 3 mL of antecubital venous blood was collected from participants and tested for serum immunoglobulin M.
Body Composition Testing
Time frame: 38 days
The participants' weight and body fat percentage were tested using the Korean INBODY 3.0.
The Profile of Mood States
Time frame: 38 days
For psychological state: the Profile of Mood States, a tool for studying mood states and their relation to exercise performance, was used. Participants answered 40 questions with a five-point scale (0 to 4 points, with 0 indicating 'almost none', 1 'a little', 2 'moderate', 3 'quite a bit', and 4 'extremely'), including seven mood dimensions: tension, anger, fatigue, depression, energy, confusion, and self-esteem. Energy and self-esteem are positive mood dimensions, with higher scores indicating better mood states, while the other five are negative mood dimensions, with higher scores indicating worse mood states. The total score, total mood disturbance (calculated as the sum of the five negative mood scores minus the sum of the two positive mood scores plus 100), indicates worse mood states with higher scores. The scale has a reliability between 0.60 and 0.82 and a validity greater than 0.90 for Chinese individuals.
Sleep quality
Time frame: 38 days
The pittsburgh sleep quality index, a questionnaire for assessing sleep quality over the past month, consists of 18 self-rated items forming seven components, with a total score ranging from 0 to 21, where higher scores indicate worse sleep quality. The scale has a reliability between 0.65 and 0.84 and a validity greater than 0.85 for Chinese individuals.
Anaerobic Power Testing
Time frame: 38 days
The Wingate 30-second anaerobic test (MONARK 894E, MONARK Company, Sweden) was used. Participants pedalled as fast as possible, adjusting to the prescribed resistance load within 3 to 4 seconds, and started timing for a 30-second all-out cycling exercise. The average power over 30 seconds, total work output, maximum power output within 5 seconds, and minimum power output within 5 seconds were recorded.
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 9 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Xiong Weizhi, Dr study chair
Chengdu Sport University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Body Weight Changes, run by Chengdu Sport University at 1 site in China.
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 5 inclusion and 4 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 9 Aug 2024. 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 China. 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?
Blood Pressure Testing (time frame: 38 days). The study lists 11 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 9 Aug 2024.