- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
-
-
Iowa
-
Cedar Falls, Iowa, Egyesült Államok, 50614
- University of Northern Iowa
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
Egészséges önkénteseket fogad
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Alapvető tudomány
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Crossover kiosztás
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Prefrontal Cortex Oxygenation
Időkeret: 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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Cycling Time-Trial Performance
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
|
Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
Egyéb vizsgálati azonosító számok
- IRB-FY24-97
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
az Egyesült Államokban gyártott és onnan exportált termék
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .