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Идёт набор NCT07135934

Effects of Single Sodium Bicarbonate Supplementation on National-Level Finswimming Performance

Без фазы С лечением Sport Performance Acid Base Imbalance Ergogenic Support Sodium Bicarbonate

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Sodium Bicarbonate (NaHCO3), Placebo.
Кому может быть актуально
Состояния в реестре: Sport Performance, Acid Base Imbalance, Ergogenic Support, Sodium Bicarbonate. Базовые параметры: 15 лет — 30 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Чехия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluation of the Effects of Single Sodium Bicarbonate Supplementation on Finswimming Performance of National Level Finswimmers: A Randomized, Double-Blind, Placebo-Controlled Crossover Study

Обзор

This randomized, double-blind, placebo-controlled crossover trial will investigate the acute effects of sodium bicarbonate supplementation on performance, stroke biomechanics, and selected physiological and perceptual responses during a simulated 200-meter Bi-Fins race in elite finswimmers.

Подробное описание

This randomized, double-blind, placebo-controlled, crossover study will examine the effects of sodium bicarbonate (NaHCO₃) supplementation on simulated finswimming performance and associated biomechanical, physiological, and perceptual responses in national-level finswimmers. Twenty participants, all active members of the Czech junior or senior national team, will complete three test sessions separated by a 48-hour recovery period without training sessions.

The first session will serve as a control with no intervention, while the second and third will involve ingestion of either sodium bicarbonate (NaHCO₃; 300 mg·kg-¹) or placebo (food-grade starch), administered in a randomized, counterbalanced order. The capsules will be indistinguishable in appearance, weight, and texture. Allocation concealment will be ensured: only a designated medical professional overseeing the health and safety of the participants will have access to the randomization codes. Neither the participants nor the investigators will be aware of the supplement condition during testing.

All sessions will be conducted under standardized conditions in a 25-meter indoor swimming pool (Aplikační centrum BALUO, Palacký University Olomouc) and will include a standardized warm-up followed by a 200-meter Bi-Fins time trial.

Blood samples for acid-base balance assessment will be collected at four time points: baseline (10 minutes before warm-up), 10 minutes after warm-up, 5 minutes before race start, and 3 minutes post-exercise. From these samples, variability in acid-base balance will be assessed, specifically using actual base excess (ABE; mmol/L), blood hydrogen ion concentration (pH; unitless), and bicarbonate concentration (HCO₃-; mmol/L). Blood lactate concentration (mmol/L) will be measured at two time points only: baseline (10 minutes before warm-up) and 3 minutes post-exercise.

Subjective perceptual responses will include:

1. rate of perceived exertion (RPE) using the Borg Category Ratio 1-10 scale, assessed immediately after the race, where higher scores indicate greater exertion; 2. gastrointestinal discomfort using the Borg Category Ratio 1-10 scale, assessed approximately 5 minutes before the race to avoid performance bias, where higher scores indicate worse discomfort; and 3. delayed-onset muscle soreness (DOMS) using a 10-centimeter visual analog scale (VAS; 0 cm = no soreness, 10 cm = extreme soreness) for both upper and lower limbs, where higher scores indicate greater soreness.

Stroke mechanics - stroke rate (SR; cycles/min) and stroke length (SL; meters/cycle) - will be analyzed from video recordings of the 200-meter trials.

The study will follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines for crossover trials and has been approved by the Ethics Committee of the Faculty of Physical Culture, Palacký University Olomouc (Ref. No. 2/2024).

Statistical analysis will include repeated-measures analysis of variance (ANOVA) to compare conditions and time points. In case of violation of assumptions, appropriate corrections or non-parametric alternatives will be applied. Descriptive statistics, effect sizes (partial eta-squared, Cohen's d), and correlation coefficients (Pearson's r) will be used to support the interpretation of results. Data will be processed using International Business Machines Statistical Package for the Social Sciences (IBM SPSS) software and Microsoft Excel.

Вмешательства

  • Пищевая добавка Sodium Bicarbonate (NaHCO3)
    Gelatin capsules each containing 1g sodium bicarbonate (NaHCO₃)
  • Пищевая добавка Placebo
    Gelatin capsules each containing 1g food-grade starch

Первичные конечные точки

  • Stroke rate (SR; cycles/min) [Срок оценки: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.]
  • Total race time (seconds) [Срок оценки: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.]
  • Stroke length (SL; meters/cycle) [Срок оценки: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.]
Вторичные конечные точки (10)
  • Underwater distance (meters) [Срок оценки: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.]
  • Blood lactate concentration (mmol/L) [Срок оценки: Baseline (10 minutes before warm-up) and 3 minutes post-exercise on each testing day]
  • Actual base excess (ABE; mmol/L) [Срок оценки: Baseline (10 minutes before warm-up), 10 minutes after warm-up, 5 minutes before race start, and 3 minutes post-exercise on each testing day]
  • Blood bicarbonate concentration (HCO₃-; mmol/L) [Срок оценки: Baseline (10 minutes before warm-up), 10 minutes after warm-up, 5 minutes before race start, and 3 minutes post-exercise on each testing day]
  • Rate of Perceived Exertion (RPE; score on Borg Category Ratio 1-10 scale) [Срок оценки: Immediately post-exercise on each testing day]
  • Gastrointestinal discomfort (score on Borg Category Ratio 1-10 scale) [Срок оценки: Approximately 5 minutes before race start on each testing day]
  • Delayed-onset muscle soreness (DOMS; score on 10-centimeter visual analog scale) [Срок оценки: Immediately post-exercise on each testing day]
  • Underwater time (seconds) [Срок оценки: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.]
  • Underwater velocity (meters/second) [Срок оценки: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.]
  • Blood hydrogen ion concentration (pH; unitless) [Срок оценки: Baseline (10 minutes before warm-up), 10 minutes after warm-up, 5 minutes before race start, and 3 minutes post-exercise on each testing day]

Критерии участия

Критерии включения

  • Member of a wider national selection in finswimming (junior or senior level)
  • Regular participation in competitive finswimming training (≥4 sessions per week)
  • Age between 15 and 30 years
  • Absence of chronic illness or injury
  • No use of medications or dietary supplements during the study period
  • Signed informed consent (for minors, also signed by a legal guardian)

Критерии исключения

  • History of gastrointestinal disorders affecting supplement tolerance
  • Presence of cardiovascular, metabolic, or musculoskeletal disorders
  • Current illness or acute infection
  • Regular use of substances that may interfere with acid-base balance
  • Refusal to comply with pre-test restrictions (e.g., 48 hours without training)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Тройное слепое
Основная цель
Фундаментальное исследование

Центры проведения

Чехия · 1 центр
  • Palacký University, Faculty of Physical Culture — Olomouc

Идентификаторы

NCT: NCT07135934 · FTK_2024_002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗