- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07714057
Effect of Hydrogen-rich Water During Tapering on Recovery After Functional Overreaching in Basketball Players
Effect of Hydrogen-rich Water Supplementation During Tapering on Recovery After Functional Overreaching in Competitive Male Basketball Players: A Randomized, Double-blind, Placebo-controlled Paralel-group Trial
The goal of this clinical trial is to evaluate whether hydrogen-rich water supplementation during tapering improves recovery after functional overreaching in competitive male basketball players aged 18-35 years. The main questions it aims to answer are:
- Does hydrogen-rich water improve autonomic recovery after functional overreaching?
- Does hydrogen-rich water improve recovery in biochemical, performance, and subjective feeling outcomes during tapering?
Researchers will compare hydrogen-rich water to placebo (water containing no molecular hydrogen) to determine whether molecular hydrogen improves recovery after accumulated fatigue has been induced by functional overreaching. Participants will:
- Complete a training cycle including normal training, functional overreaching, and tapering.
- Consume hydrogen-rich or placebo water daily during the one-week tapering period.
- Undergo repeated testing of autonomic nervous system, blood biochemical markers, performance, and subjective soreness.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The study consists of an initial screening and entry testing phase, followed by one week of normal training, two weeks of functional overreaching, and one week of tapering. During the functional overreaching period, training load is increased to approximately 120-130% of normal training load to induce accumulated fatigue. During the tapering period, training volume is reduced to approximately 50-60% of normal training volume to support recovery and performance rebound.
The molecular hydrogen is administered only during the tapering period. Participants in the experimental group consume 2.5 L per day of hydrogen-rich water. The total daily dose is divided into 0.5 L in the morning, 1.5 L around training, and 0.5 L in the evening. Participants in the placebo group consume visually matched placebo water according to the same total daily intake and timing schedule. Supplementation adherence is monitored using logs, dose counts, and attendance records. Participants are randomly assigned in a 1:1 ratio to either the experimental group or the placebo group. Randomization is performed using a block scheme and a computer random number generator.
Testing is performed at multiple time points: entry laboratory testing, baseline after normal training, post-functional overreaching, and post-taper. The primary interval for evaluation is the change from post-functional overreaching to post-taper. Statistical analysis is based on a t-test or analysis of variance. Data that not follow a normal distribution are treated using a logarithmic transformation or analyzed using nonparametric tests. The significance level is set at 0.05.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Jakub Krejci, PhD
- E-mail: jakub.krejci@upol.cz
Sauvegarde des contacts de l'étude
- Nom: Jan Kvas
- Numéro de téléphone: +420774678756
- E-mail: jan.kvas01@upol.cz
Lieux d'étude
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Olomouc, Tchéquie, 77111
- Recrutement
- Palacky University, Faculty of Physical Culture
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Contact:
- Jan Kvas
- Numéro de téléphone: +420774678756
- E-mail: jan.kvas01@upol.cz
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Competitive male basketball players.
- Signed informed consent.
- Completion of entry medical and laboratory screening.
Exclusion Criteria:
- Acute injury or infection.
- History or presence of relevant cardiovascular, respiratory, metabolic, or other disease that may affect the study results.
- Use of medication affecting recovery markers or study results.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Hydrogen-rich water
Hydrogen-rich water administered at a dose of 2.5 L per day during a one-week tapering period.
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Hydrogen-rich water with molecular hydrogen concentration >1.0 ppm.
Autres noms:
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Comparateur placebo: Placebo water
Placebo water administered at a dose of 2.5 L per day during a one-week tapering period.
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Tap water without molecular hydrogen.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
RMSSD
Délai: One-week change between post-overreaching and post-taper.
|
The root mean square of successive differences of RR intervals (RMSSD) is used as an index of parasympathetic activity and is calculated from an ECG using heart rate variability analysis.
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One-week change between post-overreaching and post-taper.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Creatine kinase
Délai: One-week change between post-overreaching and post-taper.
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Blood creatine kinase concentration is used as a marker of muscle damage.
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One-week change between post-overreaching and post-taper.
|
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High-sensitivity C-reactive protein
Délai: One-week change between post-overreaching and post-taper.
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High-sensitivity C-reactive protein concentration is used as a marker of systemic inflammatory.
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One-week change between post-overreaching and post-taper.
|
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Cortisol
Délai: One-week change between post-overreaching and post-taper.
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Blood cortisol concentration is used as a marker of physiological stress response.
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One-week change between post-overreaching and post-taper.
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Testosterone
Délai: One-week change between post-overreaching and post-taper.
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Blood testosterone concentration is used as a marker related to anabolic-catabolic balance.
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One-week change between post-overreaching and post-taper.
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Urea
Délai: One-week change between post-overreaching and post-taper.
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Blood urea concentration is used as a marker related to metabolic and protein-turnover stress.
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One-week change between post-overreaching and post-taper.
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Leukocytes
Délai: One-week change between post-overreaching and post-taper.
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Blood leukocyte count is used as a marker of immune-related response to training.
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One-week change between post-overreaching and post-taper.
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Lymphocytes
Délai: One-week change between post-overreaching and post-taper.
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Blood lymphocyte count is used as a marker of immune-related response to training.
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One-week change between post-overreaching and post-taper.
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Neutrophils
Délai: One-week change between post-overreaching and post-taper.
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Blood lymphocyte count is used as a marker of imflammatory response to training.
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One-week change between post-overreaching and post-taper.
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Reactive strength index
Délai: One-week change between post-overreaching and post-taper.
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Reactive strength index is used as an marker of neuromuscular function of the lower limbs and is measured using a drop jump.
|
One-week change between post-overreaching and post-taper.
|
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Hangrip test
Délai: One-week change between post-overreaching and post-taper.
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Handgrip test is used as a marker of forearm muscle strength and is measured using a dynamometer.
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One-week change between post-overreaching and post-taper.
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20-m sprint
Délai: One-week change between post-overreaching and post-taper.
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20-m sprint test is used to assess linear speed.
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One-week change between post-overreaching and post-taper.
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Repeated sprint
Délai: One-week change between post-overreaching and post-taper.
|
20 x 15 m repeated sprint test is used to asses repeated sprint ability.
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One-week change between post-overreaching and post-taper.
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Agility T-test
Délai: One-week change between post-overreaching and post-taper.
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Agility T-test is used to assess planned change-of-direction performance.
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One-week change between post-overreaching and post-taper.
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Basketball jump shot accuracy test
Délai: One-week change between post-overreaching and post-taper.
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Basketball jump shot accuracy test is used to assess basketball-specific performance.
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One-week change between post-overreaching and post-taper.
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Muscle soreness
Délai: One-week change between post-overreaching and post-taper.
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Muscle soreness is assessed subjectively using a visual analog scale, which is represented by a 100 mm line marked 0 (no pain) and 100 (worst imaginable pain).
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One-week change between post-overreaching and post-taper.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jan Kvas, Palacky University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- FTK_2026_13
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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