- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03482726
Cadence Modulation to Improve Well-Being, Kinematics and Aerobic Performance in Cyclists
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53705
- University of Wisconsin
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: 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.
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6-week high intensity training (HIIT) indoor cycling program, described later, at their prescribed cadence (FCC or EOC), using cadence meters.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Time to exhaustion T(max)
Prazo: Baseline
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time to reach exhaustion
|
Baseline
|
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Ventilatory threshold (VT)
Prazo: Baseline
|
Baseline
|
|
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Maximal cardiac output
Prazo: Baseline
|
Baseline
|
|
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Maximal stroke volume
Prazo: Baseline
|
Baseline
|
|
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decreased trunk lean
Prazo: Baseline
|
decrease in degree of lean in truck
|
Baseline
|
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decreased ankle dorsiflexion
Prazo: Baseline
|
decrease in amount of ankle dorsiflexion
|
Baseline
|
|
decreased knee splay
Prazo: Baseline
|
decreased degree of knee splay
|
Baseline
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Improved VO2 max
Prazo: 6 weeks
|
Increased maximum O2 volume
|
6 weeks
|
|
Increased O2 consumption at VT
Prazo: 6 weeks
|
Improved oxygen consumption at ventilatory threshold
|
6 weeks
|
|
Time to VT
Prazo: 6 weeks
|
Improved time to reach ventilatory threshold
|
6 weeks
|
|
Time to T(max)
Prazo: 6 weeks
|
Improved time to reach exhaustion
|
6 weeks
|
|
decreased trunk lean
Prazo: 6 weeks
|
decrease in degree of lean in truck
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6 weeks
|
|
decreased ankle dorsiflexion
Prazo: 6 weeks
|
decrease in amount of ankle dorsiflexion
|
6 weeks
|
|
decreased knee splay
Prazo: 6 weeks
|
decreased degree of knee splay
|
6 weeks
|
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change in overall soreness and fatigue
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 2017-0131
- A536110 (Outro identificador: UW Madison)
- SMPH\ORTHOPEDIC&REHAB\ORTHO (Outro identificador: UW Madison)
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