- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03482726
Cadence Modulation to Improve Well-Being, Kinematics and Aerobic Performance in Cyclists
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
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Wisconsin
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Madison, Wisconsin, 미국, 53705
- University of Wisconsin
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to exhaustion T(max)
기간: Baseline
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time to reach exhaustion
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Baseline
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Ventilatory threshold (VT)
기간: Baseline
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Baseline
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Maximal cardiac output
기간: Baseline
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Baseline
|
|
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Maximal stroke volume
기간: Baseline
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Baseline
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decreased trunk lean
기간: Baseline
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decrease in degree of lean in truck
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Baseline
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decreased ankle dorsiflexion
기간: Baseline
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decrease in amount of ankle dorsiflexion
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Baseline
|
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decreased knee splay
기간: Baseline
|
decreased degree of knee splay
|
Baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Improved VO2 max
기간: 6 weeks
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Increased maximum O2 volume
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6 weeks
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Increased O2 consumption at VT
기간: 6 weeks
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Improved oxygen consumption at ventilatory threshold
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6 weeks
|
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Time to VT
기간: 6 weeks
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Improved time to reach ventilatory threshold
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6 weeks
|
|
Time to T(max)
기간: 6 weeks
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Improved time to reach exhaustion
|
6 weeks
|
|
decreased trunk lean
기간: 6 weeks
|
decrease in degree of lean in truck
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6 weeks
|
|
decreased ankle dorsiflexion
기간: 6 weeks
|
decrease in amount of ankle dorsiflexion
|
6 weeks
|
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decreased knee splay
기간: 6 weeks
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decreased degree of knee splay
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6 weeks
|
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change in overall soreness and fatigue
기간: 6 weeks
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decrease in reported soreness and fatigue as measured and reported via Metrifit software
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6 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Andrew M Watson, MD, University of Wisconsin, Madison
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .