- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07630870
The Effects of Astaxanthin on Physiological Anti-fatigue and Sports Performance: an Integrated Study From the Application of Laboratory Human Sports Platform to Simulated Competitions
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
First Year: In this study, participants will be randomly assigned to either the AST group or the placebo group and will take AST supplements or a placebo (20 mg/day) for 8 weeks. You will not know whether you have been assigned to the supplement group or the placebo group. After the first trial in each group, there will be a 14-day washout period, after which the two groups will switch places to conduct the second trial. Seven days before the exercise performance test, all participants will undergo a maximal oxygen uptake (VO₂ max) test, and the intensity of the single-session cycling challenge will be calculated based on this measurement. Participants will fast for 12 hours prior to the day of the exercise challenge. They will report to the laboratory at 7:00 AM on the day of the test for body composition measurements, followed by consumption of a light meal (300 kcal) accompanied by an AST supplement or placebo capsule, and a 1-hour rest period. One hour after taking the supplement capsule, participants performed a 5-minute cycling warm-up on a human motion platform designed by the PI's laboratory, followed by a single 60-minute cycling exercise at 70% VO2max, maintaining a cadence of 60 rpm throughout. After completing the exercise challenge, participants consumed a meal (60% carbohydrates, 25% fat, 15% protein) tailored to their body weight. Then, 3 hours into the recovery period, they underwent an anaerobic power test and a subsequent exercise-to-exhaustion (Time to Exhaustion, TTE) challenge at 75% VO2max, with exercise performance times recorded. Additionally, blood and gas samples were collected before the first cycling challenge, at the 30-minute mark during the challenge, immediately after exercise, every hour during the recovery period, and after the subsequent exercise-to-exhaustion test. Following a brief recovery period (3 hours), participants performed a 30-second anaerobic power test. After a 5-minute rest, they proceeded to a 75% cycling test to exhaustion. The experimental design included administering the Profile of Mood States (POMS) questionnaire before and after each exercise challenge to assess participants' emotional tendencies during exercise. The experimental procedures and exercise performance tests for both trials were identical to those described above.
Year 2: This study employs a randomized, single-blind, crossover design. Participants will be randomly assigned to groups to receive either an AST supplement or a placebo (12 mg/day) for 4 weeks, and you will not know whether you have been assigned to the supplement or placebo group. After the first trial is completed for each group, there will be an 8-week washout period, after which the two groups will switch places to conduct the second trial. This simulated badminton competition consists of 5 matches over 5 consecutive days, with a 24-hour rest period between each match. All participants will follow a controlled diet for 3 days prior to the simulated badminton competition trial. Participants will fast starting 12 hours before the day of the simulated competition. They will report to the laboratory at 7:00 AM on the day of the test for body composition measurements, followed by consumption of a light meal (300 kcal) paired with an AST capsule or placebo. After a 3-hour rest period, the first blood draw will be performed, followed by a badminton-specific warm-up (15 minutes). Following the research assistant's instructions, participants first performed a badminton-specific warm-up for 10 to 15 minutes. Subsequently, in accordance with the latest international competition format "3 x 21-point system" established by the Badminton World Federation (Badminton World Federation, BWF) in 2006, participants were paired up to complete a simulated badminton match using the "3 x 21-point system," with a 1-minute-30-second rest period before the start of the next game. Participants were allowed to hydrate during the simulated badminton matches. Finally, to better simulate the scenario where badminton players may need to prepare for the next match immediately after completing one, the final aerobic capacity test involved a badminton-specific incremental endurance test. Participants were allowed to stop the test upon reaching exercise exhaustion, and the total exercise duration and power output were recorded. The experimental procedures and performance assessment items for both trials were the same as described above. Sport-specific physical performance assessments included upper-body grip strength, the Counter Movement Jump (CMJ), and 10-second anaerobic power.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Taichung, Taiwan
- China Medical University
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- A minimum of five years of badminton training experience (with a training frequency of at least three times per week, sustained for three consecutive years).
Exclusion Criteria:
- chronic diseases, such as heart disease or hypertension, drinking habits and severe lower limb musculoskeletal injuries within the past six months.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: Placebo
120 mg of MUFA (monounsaturated fatty acids) and a small amount of caramel food coloring as fillers.
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Supplemented with placebo for 4 weeks
Supplemented with Astaxanthin (AST) for 4 weeks (12 mg/day, AstaReal®, Sweden)
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Eksperimentel: AST
Each AST capsule contains 4 mg of astaxanthin extracted from natural algae and 120 mg of MUFA
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Supplemented with placebo for 4 weeks
Supplemented with Astaxanthin (AST) for 4 weeks (12 mg/day, AstaReal®, Sweden)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Badminton specific incremental endurance test
Tidsramme: Baseline,week 1 end of 4-week supplementation period
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The badminton specific incremental endurance test measures endurance performance through repetitive specific movements on a Y-shaped court layout (3-meter distance between points). Unit of Measure: Minutes |
Baseline,week 1 end of 4-week supplementation period
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Upper Limb Grip Strength
Tidsramme: Baseline, and before and after the simulated badminton matches in week 1 and weeks 2-4.
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Upper limb muscle strength is assessed using an electronic hand dynamometer.
The maximum value from two attempts for both left and right hands is recorded as the reference data.Unit of Measure:Kilograms.
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Baseline, and before and after the simulated badminton matches in week 1 and weeks 2-4.
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Countermovement jump, CMJ
Tidsramme: Baseline, and before and after the simulated badminton matches in week 1 and weeks 2-4.
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Lower limb maximum strength, power, and speed are evaluated using an athletic performance measurement system (OptojumpNext).
Participants execute a downward squat followed immediately by a maximal vertical jump.Unit of Measure:jump height in centimeters.
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Baseline, and before and after the simulated badminton matches in week 1 and weeks 2-4.
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Agility T test
Tidsramme: Baseline, and before and after the simulated badminton matches in week 1 and weeks 2-4.
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Athletes navigate a T-shaped course at maximum speed and touch marker cones to simulate rapid movement and directional changes in badminton offensive and defensive plays.Unit of Measure:seconds.
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Baseline, and before and after the simulated badminton matches in week 1 and weeks 2-4.
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Star Excursion Balance Test, SEBT
Tidsramme: Baseline, and before and after the simulated badminton matches in week 1 and weeks 2-4.
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Assesses dynamic balance.
Participants perform single-leg squats and reach as far as possible with the non-stance leg along 8 designated lines on the floor.Unit of Measure:Reach distance divided by leg length as a percentage (%).
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Baseline, and before and after the simulated badminton matches in week 1 and weeks 2-4.
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Superoxide Dismutase (SOD) Activity
Tidsramme: Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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biomarker used to evaluate total antioxidant capacity.And the absorbance was measured at 532 nm and 570 nm using a microplate reader (Tecan GENios, A-5082, Austria).
The final concentrations were calculated based on the standard curve.Unit of Measure: Units per milliliter (U/mL).
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Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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Malondialdehyde (MDA) Levels
Tidsramme: Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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Blood samples are collected to measure the serum concentration of MDA to evaluate the degree of lipid peroxidation and oxidative stress.Unit of Measure: Units per milliliter (U/mL).
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Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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Serum Interleukin-6 (IL-6) Concentration
Tidsramme: Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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Blood samples are collected to measure the serum concentration of IL-6 to assess exercise-induced inflammatory response.Unit of Measure: Picograms per milliliter (pg/mL).
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Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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Serum Tumor Necrosis Factor-alpha (TNF-alpha) Concentration
Tidsramme: Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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A pro-inflammatory cytokine measured in serum and to evaluate the inflammatory response.Unit of Measure: picograms per milliliter (pg/mL).
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Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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Serum Creatine Kinase (CK) Concentration
Tidsramme: Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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A biomarker of muscle damage measured in serum.The absorbance was measured at 450 nm, 505 nm, and 572 nm, respectively, using a microplate reader (Tecan GENios, A-5082, Austria) via enzyme-linked immunosorbent assay (ELISA), and serum concentrations were determined based on the standard curve.Unit of Measure: Units per Liter (U/L).
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Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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High-sensitivity C-Reactive Protein, hs-CRP
Tidsramme: Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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A biomarker of muscle damage measured in serum.The absorbance was measured at 450 nm, 505 nm, and 572 nm, respectively, using a microplate reader (Tecan GENios, A-5082, Austria) via enzyme-linked immunosorbent assay (ELISA), and serum concentrations were determined based on the standard curve.Unit of Measure: Units per Liter (U/L).
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Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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Interleukin-1 beta, IL-1β
Tidsramme: Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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Blood samples are collected to measure the serum concentration of IL-1β to assess exercise-induced inflammatory response.Unit of Measure: Picograms per milliliter (pg/mL).
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Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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Interleukin-10, IL-10
Tidsramme: Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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Blood samples are collected to measure the serum concentration of IL-10 to assess exercise-induced inflammatory response.Unit of Measure: Picograms per milliliter (pg/mL).
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Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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Uric Acid (UA) Levels
Tidsramme: Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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Measured in serum as a marker of metabolic stress and muscle damage using commercial analytical reagents.
Unit of Measure: Milligrams per deciliter (mg/dL).
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Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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Lactate Dehydrogenase (LDH) Activity
Tidsramme: Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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A biomarker of muscle damage measured in serum using an automated clinical chemistry analyzer (Beckman Coulter AU5800).Unit of Measure: Units per Liter (U/L).
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Baseline; and after game 1, game 2, and game 3 of the simulated matches in week 1 and weeks 2-4.
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Profile of Mood States (POMS) - Vigor Subscale Score
Tidsramme: Measured immediately after simulated badminton match.
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A subscale of the POMS brief version used to evaluate the positive mood state of vigor.
It consists of specific adjectives scored on a 5-point scale (1-5).
Higher scores indicate higher levels of vigor.
Unit of Measure: Units on a scale
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Measured immediately after simulated badminton match.
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Profile of Mood States (POMS) - Self-esteem Subscale Score
Tidsramme: Measured immediately after simulated badminton match.
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A subscale of the POMS brief version used to evaluate the mood state of self-esteem.
Scored on a 5-point scale (1-5).
Higher scores indicate higher levels of self-esteem.
Unit of Measure: Units on a scale.
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Measured immediately after simulated badminton match.
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Profile of Mood States (POMS) - Tension Subscale Score
Tidsramme: Measured immediately after simulated badminton match.
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A subscale of the POMS brief version used to evaluate the negative mood state of tension.
Scored on a 5-point scale (1-5).
Higher scores indicate higher levels of tension.
Unit of Measure: Units on a scale
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Measured immediately after simulated badminton match.
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Profile of Mood States (POMS) - Confusion Subscale Score
Tidsramme: Measured immediately after simulated badminton match.
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A subscale of the POMS brief version used to evaluate the negative mood state of confusion.
Scored on a 5-point scale (1-5).
Higher scores indicate higher levels of confusion.
Unit of Measure: Units on a scale
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Measured immediately after simulated badminton match.
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Profile of Mood States (POMS) - Anger Subscale Score
Tidsramme: Measured immediately after simulated badminton match.
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A subscale of the POMS brief version used to evaluate the negative mood state of anger.
Scored on a 5-point scale (1-5).
Higher scores indicate higher levels of anger.
Unit of Measure: Units on a scale
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Measured immediately after simulated badminton match.
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Profile of Mood States (POMS) - Fatigue Subscale Score
Tidsramme: Measured immediately after simulated badminton match.
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A subscale of the POMS brief version used to evaluate the negative mood state of fatigue.
Scored on a 5-point scale (1-5).
Higher scores indicate higher levels of fatigue.
Unit of Measure: Units on a scale
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Measured immediately after simulated badminton match.
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Profile of Mood States (POMS) - Depression Subscale Score
Tidsramme: Measured immediately after simulated badminton match.
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A subscale of the POMS brief version used to evaluate the negative mood state of depression.
Scored on a 5-point scale (1-5).
Higher scores indicate higher levels of depression.
Unit of Measure: Units on a scale
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Measured immediately after simulated badminton match.
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Anaerobic Peak Power
Tidsramme: Measured before and after each simulated badminton match.
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The highest power output achieved during the modified 10-second Wingate anaerobic test on a Monark 894E stationary ergometer bike.
This value reflects the explosive anaerobic power of the badminton players, typically reached within the first 3 to 5 seconds of the test.
The resistance load is set at body weight (kg) × 0.75.Unit of Measure: Watts (W)
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Measured before and after each simulated badminton match.
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Relative Anaerobic Peak Power
Tidsramme: Measured before and after each simulated badminton match.
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The anaerobic peak power output divided by the participant's body weight, obtained during the modified 10-second Wingate anaerobic test on a Monark 894E stationary ergometer bike.
This normalization accounts for individual differences in body mass among badminton players.
Unit of Measure: Watts per kilogram (W/kg)
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Measured before and after each simulated badminton match.
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Absolute Mean Power / Total Work
Tidsramme: Measured before and after each simulated badminton match.
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The average power output (total work) sustained over the entire duration of the modified 10-second Wingate anaerobic test on a Monark 894E stationary ergometer bike. This value represents the anaerobic endurance capacity required during intense badminton rallies. Unit of Measure: Watts (W) |
Measured before and after each simulated badminton match.
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Relative Anaerobic Mean Power
Tidsramme: Measured before and after each simulated badminton match.
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The average power output sustained over the 10-second test divided by the participant's body weight, obtained during the modified 10-second Wingate anaerobic test on a Monark 894E stationary ergometer bike. Unit of Measure: Watts per kilogram (W/kg) |
Measured before and after each simulated badminton match.
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Time to Peak Anaerobic Power
Tidsramme: Measured before and after each simulated badminton match.
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The duration from the start of the 10-second maximum effort pedaling until the peak power output is attained during the modified Wingate anaerobic test on a Monark 894E stationary ergometer bike. This metric evaluates how rapidly the badminton player can mobilize and express maximum explosive anaerobic energy (typically expected within the first 3 to 5 seconds). Unit of Measure: Seconds (s) |
Measured before and after each simulated badminton match.
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Maximum Heart Rate
Tidsramme: Continuous measurement throughout the 3-game simulated match (data extracted post-match).
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The highest heart rate recorded using a Garmin HRM-Pro chest strap heart rate monitor during the 3-game simulated badminton match to assess peak cardiovascular strain. Unit of Measure: Beats per minute (bpm) |
Continuous measurement throughout the 3-game simulated match (data extracted post-match).
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Mean Heart Rate
Tidsramme: Continuous measurement throughout the 3-game simulated match (data extracted post-match).
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The average heart rate recorded using a Garmin HRM-Pro chest strap heart rate monitor across the entire duration of the 3-game simulated badminton match to evaluate overall cardiovascular workload. Unit of Measure: Beats per minute (bpm) |
Continuous measurement throughout the 3-game simulated match (data extracted post-match).
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Rating of Perceived Exertion (RPE)
Tidsramme: Measured immediately at the end of Game 1, Game 2, and Game 3 during the simulated match.
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Participants' subjective rating of exercise intensity assessed using the Borg RPE scale (6-20 scale), where 6 represents "no exertion at all" and 20 represents "maximal exertion." The RPE is surveyed immediately after the completion of each game within the simulated match. Unit of Measure: Units on a scale |
Measured immediately at the end of Game 1, Game 2, and Game 3 during the simulated match.
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Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Jung-Piao Tsao, China Medical University, China
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CMUH114-REC3-003
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