- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Iowa
-
Cedar Falls, Iowa, Stany Zjednoczone, 50614
- University of Northern Iowa
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
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.
|
|
Eksperymentalny: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Prefrontal Cortex Oxygenation
Ramy czasowe: All throughout each 5-kilometer cycling time trial, approximately 10 minutes
|
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.
|
All throughout each 5-kilometer cycling time trial, approximately 10 minutes
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Cycling Time-Trial Performance
Ramy czasowe: At completion of each 5-kilometer cycling time trial, approximately 30 seconds
|
Time in seconds required to complete the 5-kilometer cycling time trial was recorded for the Q-Collar and control conditions.
|
At completion of each 5-kilometer cycling time trial, approximately 30 seconds
|
|
Choice Reaction Time
Ramy czasowe: 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
|
Choice reaction time was assessed using a computerized Stroop task.
Reaction time and response accuracy were evaluated across the Q-Collar and control conditions.
|
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
|
|
Heart Rate
Ramy czasowe: During each 5-kilometer cycling time trial, approximately 10 minutes
|
Heart rate was continuously assessed using cardiac impedance and compared across the Q-Collar and control conditions.
|
During each 5-kilometer cycling time trial, approximately 10 minutes
|
|
Stroke Volume
Ramy czasowe: During each 5-kilometer cycling time trial, approximately 10 minutes
|
Stroke volume was continuously assessed using cardiac impedance and compared across the Q-Collar and control conditions.
|
During each 5-kilometer cycling time trial, approximately 10 minutes
|
|
Cardiac Output
Ramy czasowe: During each 5-kilometer cycling time trial, approximately 10 minutes
|
Cardiac output was continuously assessed using cardiac impedance and compared across the Q-Collar and control conditions.
|
During each 5-kilometer cycling time trial, approximately 10 minutes
|
|
Blood Lactate
Ramy czasowe: Immediately following each 5-kilometer cycling time trial, approximately 1 minute
|
Blood lactate concentration (mmol/L) was measured from an earlobe capillary blood sample immediately following each cycling time trial.
|
Immediately following each 5-kilometer cycling time trial, approximately 1 minute
|
|
Rating of Perceived Exertion
Ramy czasowe: Immediately following each 5-kilometer cycling time trial, approximately 30 seconds
|
Rating of perceived exertion was assessed using the Borg 6-20 scale immediately following each 5-kilometer cycling time trial.
|
Immediately following each 5-kilometer cycling time trial, approximately 30 seconds
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- IRB-FY24-97
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .