- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04733911
Recovery Kinetics Following Eccentric Exercise
Recovery Kinetics Following Three Exercise-induced Muscle Damage Protocols in Adult Males
연구 개요
상태
정황
상세 설명
It is known that eccentric exercise induces muscle microtrauma. Also, eccentric type of exercise are associated with inflammatory response. The leukocytes and the immune cells during the phagocytosis process alter the redox status causing secondary muscle damage to the muscle tissue and also increase oxidative stress concentration. Despite of the existence of studies that examine the muscle damage indicators, inflammatory response, performance and neuromuscular fatigue and oxidative stress concentrations after eccentric exercise, however no studies are detected in order to compare the differences among three eccentric protocols. The eccentric protocols will be differentiated in training volume and specifically in the eccentric repetitions in isokinetic dynamometer. Specifically, a randomized, fourth-trial, cross-over, repeated measures design will be applied. Healthy male adults (age 18-30 years) will participate in the present study. Also, it is considered necessary that the participants will not suffer from any musculoskeletal injuries that will limit their ability to perform the exercise protocols. Also the participants will not be smokers and will not consume alcohol and nutritional supplements.
In the first phase all participants will sign an informed consent form after they will be informed about all benefits and risks of this study and they will sign a recent historical of musculoskeletal injury or illness form. Subsequently, fasting blood samples will be collected by venipuncture using a disposable needle (20-gauge) in order to measure muscle damage markers (CK), inflammation markers (WBC) and oxidative stress markers (TBARS, PC, GSH, ΤΑC, CAT, UA). After, delayed onset muscle soreness (DOMS) in the knee flexors (KF) and extensors (KE) of both limbs, body weight (BW), height and body composition (DXA method) will be measured in the lab. Completing the first phase, participants will be instructed by a dietitian how to record a 5 days diet recalls estimating the energy intake during the trials will be the same. The knee range of motion (KJRM) will be determined by the use of a goniometer, 24 hours after (second phase). The counter movement jump (CMJ) will be evaluated on a force platform using two force platforms at 1000 Hz, with each foot in parallel on the two platforms providing a separate yet time-synchronized measurement of the data for each leg. During the CMJ will be measured the jump height (cm), the ground reaction force (N), the peak and mean power (W/kg), the vertical stiffness (Kvert, N/m/kg) and the peak rate of force development (RFD, N/s), while at the same time will be evaluated the change in peak and mean normalized EMG during the eccentric and concentric phases of the counter movement jump, for the vastus medialis (VM) and vastus lateralis muscles. Electromyography data will be collected wirelessly at 2.000 Hz using a Myon MA-320 EMG system. The peak eccentric and concentric isokinetic torque of the knee flexors and extensors, in both limbs will be evaluated on an isokinetic dynamometer at 60°/sec. Also, the isometric peak torque of the knee extensors will be evaluated at 65° in both limbs. Finally, Open-circuit spirometry will be utilized for assessment of maximal oxygen consumption (VO2max) using an automated online pulmonary gas exchange system via breath-by-breath analysis during a graded exercise testing on a treadmill.
96 hours after, the participants are going to perform one of the three eccentric protocols randomly, on an isokinetic dynamometer. The eccentric protocol will be performed on a different limb for each trial. The ECC 75 trial will include 75 eccentric maximum repetitions (5 sets, 15 reps/set and recovery period: 30sec.) at 60°/sec. The ECC 150 trial will include 150 eccentric maximum repetitions (10 sets, 15 reps/set and recovery period: 30sec.) at 60°/sec. The ECC 300 trial will include 300 eccentric maximum repetitions (20 sets, 15 reps/set and recovery period: 30sec.) at 60°/sec. The DOMS indicator in the knee flexors (KF) and extensors (KE) of both limbs and the KJRM will be evaluated immediately after each protocol. Also, the (CMJ) will be evaluated on a force platform using two force platforms at 1000 Hz, with each foot in parallel on the two platforms providing a separate yet time-synchronized measurement of the data for each leg. During the CMJ will be measured the jump height (cm), the ground reaction force (N), the peak and mean power (W/kg), the vertical stiffness (Kvert, N/m/kg) and the peak rate of force development (RFD, N/s), while at the same time will be evaluated the change in peak and mean normalized EMG during the eccentric and concentric phases of the counter movement jump, for the vastus medialis (VM) and vastus lateralis muscles. Electromyography data will be collected wirelessly at 2.000 Hz using a Myon MA-320 EMG system. In addition, the peak eccentric and concentric isokinetic torque of the knee flexors and extensors, in both limbs will be evaluated on an isokinetic dynamometer at 60o/sec. Also, the isometric peak torque of the knee extensors will be evaluated at 65o in both limbs. All the above markers will be evaluated 24, 48 and 192 hours post eccentric protocol, however at these time points, fasting blood samples (20ml) will be collected in order to estimate hematological and biochemical indicators. Α 2 - week washout period will be adapted among trials. After, the participants will perform the process until they complete the trials.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Tríkala, 그리스, 42100
- University o Thessaly, School of Physical Education and Sports Science
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Aged between 18 and 30 years
- Body Mass Index between 18.5-24.9 kg/m*m
- Free of chronic diseases
- Free of musculoskeletal injury
- participants should be non-smokers
Exclusion Criteria:
- Musculoskeletal injury
- Chronic disease
- Use of alcohol, caffeine and any type of nutritional supplements or medication before (≥ 6 months) and throughout the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 제어
이 팔의 참가자는 개입을 받지 않습니다.
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실험적: Eccentric 75
Participants in this arm will perform an eccentric exercise protocol consisted of 75 eccentric repetetions on an isokinetic dynamometer.
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An acute bout of eccentric exercise will be performed on an isokinetic dynamometer, including 5 sets of 15 repetitions, with 30 sec rest intervals,at 60 degrees/sec.
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실험적: Eccentric 150
Participants in this arm will perform an eccentric exercise protocol consisted of 150 eccentric repetetions on an isokinetic dynamometer.
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An acute bout of eccentric exercise will be performed on an isokinetic dynamometer, including 10 sets of 15 repetitions, with 30 sec rest intervals,at 60 degrees/sec.
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실험적: Eccentric 300
Participants in this arm will perform an eccentric exercise protocol consisted of 300 eccentric repetetions on an isokinetic dynamometer.
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An acute bout of eccentric exercise will be performed on an isokinetic dynamometer, including 20 sets of 15 repetitions, with 30 sec rest intervals,at 60 degrees/sec.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in white blood cell count
기간: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
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White blood cell count will be measured using an automatic blood analyzer
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At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in catalase activity
기간: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Concentration of catalase will be measured in red blood cells
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At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in uric acid in plasma
기간: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
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concentration of uric acid will be measured in plasma
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At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in protein carbonyls in blood
기간: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Concentration of protein carbonyls will be measured in red blood cells
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At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in total antioxidant capacity
기간: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
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total antioxidant capacity will be measured in serum
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At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in reduced glutathione in blood
기간: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Concentration of oxidized glutathione will be measured in red blood cells
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At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in thiobarbituric acid reactive substances
기간: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Thiobarbituric acid will be measured in plasma
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At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in Creatine kinase in blood
기간: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Creatine kinase will be measured in plasma
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At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in countermovement jump height
기간: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
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Countermovement jump height will be measured using two force platforms at 1000 Hz, with each foot in parallel on the two platforms providing a separate yet time-synchronized measurement of the jump height data for each leg.
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At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in ground reaction force (GRF) during countermovement jump test
기간: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
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The ground reaction force will be measured using two force platforms at 1000 Hz, with each foot in parallel on the two platforms providing a separate yet time-synchronized measurement of the GRF data for each leg.
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At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in peak power during countermovement jump test
기간: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
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The peak power will be measured using two force platforms at 1000 Hz, with each foot in parallel on the two platforms providing a separate yet time-synchronized measurement of the peak power data for each leg.
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At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in mean power during countermovement jump test
기간: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
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The mean power will be measured using two force platforms at 1000 Hz, with each foot in parallel on the two platforms providing a separate yet time-synchronized measurement of the mean power data for each leg.
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At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in vertical stifness during countermovement jump test
기간: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
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The vertical stiffness will be measured using two force platforms at 1000 Hz, with each foot in parallel on the two platforms providing a separate yet time-synchronized measurement of vertical stifness data for each leg.
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At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in peak rate of force develpemnt during countermovement jump test
기간: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
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The Peak rate of force development will be measured using two force platforms at 1000 Hz, with each foot in parallel on the two platforms providing a separate yet time-synchronized measurement of the Peak RFD data for each leg.
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At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in peak normalized EMG during the eccentric and concentric phases of the counter movement jump
기간: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
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Electromyography data will be collected wirelessly at 2.000 Hz using a Myon MA-320 EMG system (Myon AG, Schwarzenberg, Switzerland) for the vastus medialis (VM) and vastus lateralis muscles.
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At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in mean normalized EMG during the eccentric and concentric phases of the counter movement jump
기간: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
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Electromyography data will be collected wirelessly at 2.000 Hz using a Myon MA-320 EMG system (Myon AG, Schwarzenberg, Switzerland) for the vastus medialis (VM) and vastus lateralis muscles.
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At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in knee range of motion
기간: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
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Knee range of motion will be measured by goniometer
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At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in eccentric isokinetic knee extensors peak torque
기간: At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Eccentric isokinetic knee extensors peak torque will be assessed on an isokinetic dynamometer
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At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in concentric isokinetic knee extensors peak torque
기간: At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Concentric isokinetic knee extensors peak torque will be assessed on an isokinetic dynamometer
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At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in eccentric isokinetic knee flexors peak torque
기간: At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Eccentric isokinetic knee flexors peak torque will be assessed on an isokinetic dynamometer
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At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in concentric isokinetic knee flexors peak torque
기간: At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Concentric Iisokinetic knee flexors peak torque will be assessed on an isokinetic dynamometer
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At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in isometric peak torque
기간: At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
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The isometric peak torque will be assessed on an isokinetic dyanmometer
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At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in fatigue index of isometric torque during 10 second
기간: At baseline, 1hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Fatigue rate during MVIC will be estimated through the percent drop of peak torque between the first and the last three seconds of a 10-secong maximal isometric contraction.
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At baseline, 1hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Change in delayed onset of muscle soreness (DOMS) in the knee flexors (KF) and extensors (KE) of both limbs
기간: At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
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Muscle soreness (KF and KE) will be assessed during palpation of the muscle belly and the distal region
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At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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체중
기간: 기준선에서
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체중은 스타디오미터가 있는 빔 저울에서 측정됩니다.
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기준선에서
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몸 높이
기간: 기준선에서
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신장은 스타디오미터가 있는 빔 밸런스에서 측정됩니다.
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기준선에서
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체지방
기간: 기준선에서
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체지방은 Dual-emission X-ray 흡광측정법을 사용하여 측정됩니다.
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기준선에서
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Dietary intake
기간: Over a 5 -day period at baseline
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Dietary intake will be assessed using 5 -day diet recalls
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Over a 5 -day period at baseline
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최대 산소 소비량(VO2max)
기간: 기준선에서
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최대 산소 소비량은 호흡별 방법을 통해 개방 회로 폐활량 측정법으로 측정됩니다.
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기준선에서
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공동 작업자 및 조사자
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. .
75 eccentric contractions에 대한 임상 시험
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