- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Iowa
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Cedar Falls, Iowa, Estados Unidos, 50614
- University of Northern Iowa
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Prefrontal Cortex Oxygenation
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cycling Time-Trial Performance
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- IRB-FY24-97
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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