- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03482726
Cadence Modulation to Improve Well-Being, Kinematics and Aerobic Performance in Cyclists
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In the first session, each individual will be asked to fill out a questionnaire to regarding cycling experience, prior bike fits (with data sheets when available), and injury history. Maximal aerobic capacity (VO2max) will be determined. During the test, subjects will be asked rate exertion. Before testing, the system will be calibrated with known oxygen and carbon dioxide concentrations. During the test, subjects will be asked to breathe normally through a low dead space bidirectional turbine. Inspired and expired gases will be analyzed for concentrations of O2 and CO2, to determine alveolar gas exchange. Total ventilation (VE), respiratory rate, oxygen consumption (VO2), carbon dioxide (VCO2) will be measured, and respiratory exchange ratio (RER; VCO2/VO2) will be calculated continuously during the test and expressed as a 30-second rolling average.
Participants will return 48 hours later, at which time EOC will be determined after a moderate intensity prolonged cycling exercise (PCE) at seven different cadences. Cadences from 50rpm to 110rpm will be randomly generated and introduced every 3 minutes, followed by a 3 minute cool down at FCC at 40% PP (Figure Subjects will then be pair matched by gender and randomized into control (FCC) or EOC modulation groups.
48 hours following EOC testing, subject will return for a second progressive maximal cycling test performed at FCC or EOC based on group assignment.
Subjects will then participate in a 6 week high intensity training (HIIT) indoor cycling program at their prescribed cadence (FCC or EOC), using cadence meters. Training will consist of three non-consecutive days each week for 60 min, and alternate between two HIIT workouts. Resistance will be increased to meet the HIIT requirement, while cadence will remain at FCC or EOC. Subjects will be asked to warm-up at a light (3/10) workload for 10 minutes, followed by HIIT consisting of 4 minutes at an intensity of 8/10 on the modified Borg, and 90 seconds recovery (2/10). This will be repeated 8 times, followed by 10 minutes of cool down. The alternating HIIT workout will include a 10 minute warm up, followed by 12 intervals lasting 2 minutes at an RPE of 9/10 and 3 minutes of recovery. The session will conclude with a 10 minute cool down.
Within one week of completing their training program, subjects will return for their fourth and final study visit, at which time a VO2max test and kinematic data collection will be repeated at FCC or EOC.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Wisconsin
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Madison, Wisconsin, Estados Unidos, 53705
- University of Wisconsin
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- An experienced cyclist will be defined as one with at least 5 years of cycling experience and 5000 miles of training on a road bike with a clipless pedal system.
- Able to tolerate strenuous, maximal exercise and comply with a 6 week training protocol
- Have access to an indoor trainer or spin bike with a cadence sensor in order to train 3 times per week for 60 minutes
Exclusion Criteria:
- Taking medication which could impact cardiovascular function or performance (stimulants, beta-blockers, e.g.)
- Significant cardiac or pulmonary disease (congenital cardiac disease, uncontrolled hypertension, uncontrolled asthma, e.g.)
- Musculoskeletal injuries that preclude a maximal cycling effort and participation in training program
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Cycling Cadence Modulation
3 initial visits to collect baseline information; 6-week HIIT indoor cycling program at the individual prescribed cadence; final study visit for post-intervention measures.
|
6-week high intensity training (HIIT) indoor cycling program, described later, at their prescribed cadence (FCC or EOC), using cadence meters.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to exhaustion T(max)
Periodo de tiempo: Baseline
|
time to reach exhaustion
|
Baseline
|
|
Ventilatory threshold (VT)
Periodo de tiempo: Baseline
|
Baseline
|
|
|
Maximal cardiac output
Periodo de tiempo: Baseline
|
Baseline
|
|
|
Maximal stroke volume
Periodo de tiempo: Baseline
|
Baseline
|
|
|
decreased trunk lean
Periodo de tiempo: Baseline
|
decrease in degree of lean in truck
|
Baseline
|
|
decreased ankle dorsiflexion
Periodo de tiempo: Baseline
|
decrease in amount of ankle dorsiflexion
|
Baseline
|
|
decreased knee splay
Periodo de tiempo: Baseline
|
decreased degree of knee splay
|
Baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Improved VO2 max
Periodo de tiempo: 6 weeks
|
Increased maximum O2 volume
|
6 weeks
|
|
Increased O2 consumption at VT
Periodo de tiempo: 6 weeks
|
Improved oxygen consumption at ventilatory threshold
|
6 weeks
|
|
Time to VT
Periodo de tiempo: 6 weeks
|
Improved time to reach ventilatory threshold
|
6 weeks
|
|
Time to T(max)
Periodo de tiempo: 6 weeks
|
Improved time to reach exhaustion
|
6 weeks
|
|
decreased trunk lean
Periodo de tiempo: 6 weeks
|
decrease in degree of lean in truck
|
6 weeks
|
|
decreased ankle dorsiflexion
Periodo de tiempo: 6 weeks
|
decrease in amount of ankle dorsiflexion
|
6 weeks
|
|
decreased knee splay
Periodo de tiempo: 6 weeks
|
decreased degree of knee splay
|
6 weeks
|
|
change in overall soreness and fatigue
Periodo de tiempo: 6 weeks
|
decrease in reported soreness and fatigue as measured and reported via Metrifit software
|
6 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Andrew M Watson, MD, University of Wisconsin, Madison
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
- 2017-0131
- A536110 (Otro identificador: UW Madison)
- SMPH\ORTHOPEDIC&REHAB\ORTHO (Otro identificador: UW Madison)
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.
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