- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
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Iowa
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Cedar Falls, Iowa, Yhdysvallat, 50614
- University of Northern Iowa
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Perustiede
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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.
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Kokeellinen: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Prefrontal Cortex Oxygenation
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Cycling Time-Trial Performance
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- IRB-FY24-97
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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