- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07808710
Effects of the Q-Collar During High-Intensity Cycling Exercise
Cardiovascular, Cerebral, and Performance Responses to Q-Collar™ Use in a 5-km Cycling Time Trial
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
This randomized crossover study examined the effects of Q-Collar use during high-intensity cycling exercise. Recreationally trained male participants completed two laboratory testing sessions in randomized order: a 5-kilometer cycling time trial while wearing the Q-Collar and a 5-kilometer cycling time trial without the Q-Collar. The Q-Collar applies mild bilateral compression to the internal jugular veins and is designed to increase cerebral blood volume.
During each trial, cardiovascular responses were assessed continuously, while prefrontal cortex oxygenation was measured using functional near-infrared spectroscopy. Blood lactate and ratings of perceived exertion were assessed during exercise, and cognitive performance was evaluated before and after each cycling trial. Cycling performance was also recorded.
The study was designed to determine whether wearing the Q-Collar alters physiological responses to high-intensity exercise, particularly cardiovascular function and prefrontal cortex oxygenation, and whether these responses are accompanied by changes in cognitive or cycling performance. The crossover design allowed each participant to complete both conditions and therefore serve as his own control.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Iowa
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Cedar Falls, Iowa, Spojené státy, 50614
- University of Northern Iowa
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Male participants
- 18-35 years old
- Recreationally trained
- Provided written informed consent
- Achieved a maximal oxygen consumption (VO₂max) classified as "good" or "excellent" during cardiopulmonary exercise testing
Exclusion Criteria:
- Failure to meet the required "good" or "excellent" VO₂max classification during cardiopulmonary exercise testing
- Outside age range
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Q-Collar Then Control
Participants completed a 5-kilometer cycling time trial while wearing the Q-Collar, followed by a control 5-kilometer cycling time trial without the Q-Collar after a washout period of at least 72 hours.
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The Q-Collar™ is a wearable neck device that applies mild bilateral compression to the internal jugular veins.
Participants wore the Q-Collar during a 5-kilometer cycling time trial.
The device was individually fitted according to manufacturer guidelines and remained in place throughout the exercise trial.
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Experimentální: Control Then Q-Collar
Participants completed a control 5-kilometer cycling time trial without the Q-Collar, followed by a 5-kilometer cycling time trial while wearing the Q-Collar after a washout period of at least 72 hours.
|
The Q-Collar™ is a wearable neck device that applies mild bilateral compression to the internal jugular veins.
Participants wore the Q-Collar during a 5-kilometer cycling time trial.
The device was individually fitted according to manufacturer guidelines and remained in place throughout the exercise trial.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Prefrontal Cortex Oxygenation
Časové okno: All throughout each 5-kilometer cycling time trial, approximately 10 minutes
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Changes in prefrontal cortex oxygenated hemoglobin were continuously measured using functional near-infrared spectroscopy during 5-kilometer cycling time trials performed with and without the Q-Collar.
Data were evaluated across kilometer time points.
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All throughout each 5-kilometer cycling time trial, approximately 10 minutes
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Cycling Time-Trial Performance
Časové okno: At completion of each 5-kilometer cycling time trial, approximately 30 seconds
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Time in seconds required to complete the 5-kilometer cycling time trial was recorded for the Q-Collar and control conditions.
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At completion of each 5-kilometer cycling time trial, approximately 30 seconds
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Choice Reaction Time
Časové okno: At baseline, 5 minutes into exercise, immediately post-exercise, and 10 minutes post-exercise during each experimental visit, approximately 2 minutes at each time point
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Choice reaction time was assessed using a computerized Stroop task.
Reaction time and response accuracy were evaluated across the Q-Collar and control conditions.
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At baseline, 5 minutes into exercise, immediately post-exercise, and 10 minutes post-exercise during each experimental visit, approximately 2 minutes at each time point
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Heart Rate
Časové okno: During each 5-kilometer cycling time trial, approximately 10 minutes
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Heart rate was continuously assessed using cardiac impedance and compared across the Q-Collar and control conditions.
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During each 5-kilometer cycling time trial, approximately 10 minutes
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Stroke Volume
Časové okno: During each 5-kilometer cycling time trial, approximately 10 minutes
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Stroke volume was continuously assessed using cardiac impedance and compared across the Q-Collar and control conditions.
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During each 5-kilometer cycling time trial, approximately 10 minutes
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Cardiac Output
Časové okno: During each 5-kilometer cycling time trial, approximately 10 minutes
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Cardiac output was continuously assessed using cardiac impedance and compared across the Q-Collar and control conditions.
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During each 5-kilometer cycling time trial, approximately 10 minutes
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Blood Lactate
Časové okno: Immediately following each 5-kilometer cycling time trial, approximately 1 minute
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Blood lactate concentration (mmol/L) was measured from an earlobe capillary blood sample immediately following each cycling time trial.
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Immediately following each 5-kilometer cycling time trial, approximately 1 minute
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Rating of Perceived Exertion
Časové okno: Immediately following each 5-kilometer cycling time trial, approximately 30 seconds
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Rating of perceived exertion was assessed using the Borg 6-20 scale immediately following each 5-kilometer cycling time trial.
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Immediately following each 5-kilometer cycling time trial, approximately 30 seconds
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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