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临床试验/NCT03083509
NCT03083509已完成不适用

A Physiological Profile of Recovery From Mechanical, Metabolic, and Mixed Exercise Stressors

GlaxoSmithKline2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Maximal isometric volume contraction (MIVC)

研究概览

简要总结

The aim of this study to increase understanding of physiological and functional perturbations following a continuum of exercise stressors.

详细描述

This study utilised a between groups design, with a within-groups control. This allowed the within-subject profiling of recovery during both a control and exercise week. This design also allowed each group to perform an ecologically valid exercise session as well as having markers of recovery tailored to the areas of interest specific to each cohort. By having each group perform a non-exercise control week, this gives valuable information on the reliability and smallest worthwhile change for a range of both novel and commonly used recovery markers.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent (see Appendices 2-4) and has received a signed and dated copy of the informed consent form.
  • Participant is male
  • Good general and mental health as assessed by a health questionnaire and with, in the opinion of the investigator or medically qualified designee ,no clinically significant and relevant abnormalities in medical history or upon oral examination. As well as absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
  • Participants will be fully briefed prior to agreeing to participate in the study and the research team will confirm that they are willing, able, and likely to comply with all procedures and complete the study.
  • Only the following individuals will be recruited as participants for the study:
  • Group 1: Resistance trained individuals (≥3 sessions per week for ≥2 years with a minimum of 1 session per week including leg-based exercises).
  • Group 2: Trained cyclists (competing at a minimum of Category 3 roadracing/ estimated 10 mile TT of <25 minutes and a training history of ≥5 hours per week for ≥2 years).
  • Group 3: Team sports players (minimum of University 1st team level e.g. soccer, rugby union, rugby league, hockey, and basketball, playing competitively ≥1x per week for ≥2 years).

排除标准

  • Individuals that do not fit the training status inclusion criteria.
  • Current use of any non-steroidal anti-inflammatory drugs (NSAID's) or other analgesics for pain relief.
  • Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
  • Previous participation in this study.
  • Recent history (within the last 1 year) of alcohol or other substance abuse.
  • An employee of the sponsor or the study site or members of their immediate family.
  • Have a heart or any other medical condition that may contra-indicate participants from taking part in high intensity or exhaustive physical activity.

研究组 & 干预措施

Group1 (Resistance trained individuals)

Other

Resistance trained individuals (>3 sessions per weeks for ≥2 years with a minimum of 1 session per week including leg-based exercises)

干预措施: Resistance exercise weight training session (Other)

Group 2 (Trained cyclists)

Other

Trained cyclists (competing at a minimum of Category 3 road racing/estimated 10 mile TT of <25 minutes and a training history of ≥5 hours per week for ≥2 years)

干预措施: High-Intensity stochastic cycling session (Other)

Group 3 (Team sports players)

Other

Team sports players (minimum of University 1st team level e.g. soccer, rugby union, rugby league, hockey and basketball, playing competitively ≥1x per week for ≥2 years)

干预措施: Simulated Team sport protocol (Other)

结局指标

主要结局

Maximal isometric volume contraction (MIVC)

时间窗: Up to Day 26

Following a five minute warm-up cycling at 100W (Power output of the cycle in watts), participants seated on a dynamometer. For each participant the chair height, length and dynamometer position were recorded and maintained in subsequent trials. Participants completed a standardised warm-up consisting of contractions at 50, 75, and 90% of perceived maximal force. Participants then performed three MIVC of the dominant limb each lasting approximately 3 seconds (sec). Sixty seconds rest was given in between repetitions with peak force (N) recorded and the best attempt used for subsequent analysis.

20 meter (m) sprint assessment (Group 1 and 3 only)

时间窗: Up to Day 26

A 20 m runway in an indoor track was marked using cones and two sets of infrared timing gates, one set at each end of the start and finish line. Participants completed a standardised warm-up consisting of performing 20 m runs at 50, 75, and 90% of perceived maximal effort. Participants stand 0.3 m behind the start line to avoid premature triggering of the timing system, and were instructed to lead with the same starting leg for all attempts before performing three sprints interspersed with 60sec rest. Sprint time (sec) was recorded and the best attempt was used for subsequent analysis.

Rate of force development (RFD)

时间窗: Up to Day 26

Participants were instructed to stand with their feet approximately shoulder width apart on a force plate, with hands placed on hips. Participants completed a standardised warm-up consisting of jumps at 50, 75, and 90% of perceived maximum jump height. Participants were instructed to perform a maximal vertical jump by using their own choice of depth and pace (whilst maintaining hands on hips throughout) and to land with straight legs. If flight time is exaggerated by participants removing hands from the hips or bending their legs whilst in the air, the test was performed again. Three maximal efforts were performed with sixty seconds rest in between repetitions, RFD (N·s-1) recorded, and the best attempt used for subsequent analysis.

Countermovement jump (CMJ)

时间窗: Up to Day 26

Participants were instructed to stand with their feet approximately shoulder width apart on a force plate, with hands placed on hips. Participants completed a standardised warm-up consisting of jumps at 50, 75, and 90% of perceived maximum jump height. Participants were instructed to perform a maximal vertical jump by using their own choice of depth and pace (whilst maintaining hands on hips throughout) and to land with straight legs. If flight time is exaggerated by participants removing hands from the hips or bending their legs whilst in the air, the test was performed again. Three maximal efforts were performed with sixty seconds rest in between repetitions with jump height (cm) recorded, and the best attempt was used for subsequent analysis.

Cycling Time-Trial performance assessment (Group 2 only)

时间窗: Up to Day 26

Following a standardised five minute warm-up at 100 W, with a 10sec sprint at 2 minutes 30 sec, participants completed a 5 minute all-out time trial, covering as much distance as possible. Participants were initially instructed that they were to cover as much distance as possible in 5 minutes, before being blinded to time and test performance and informed of the half-way stage by the investigator. Distance covered (m), mean power (W) and work done (J) were calculated and used for subsequent analysis.

次要结局

  • Time in bed(Up to Day 26)
  • Perceived recovery measured by the daily analyses of life demands for athletes (DALDA) questionnaire(Up to Day 26)
  • Perceived muscle soreness(Up to Day 26)
  • Interleukin 10 (IL-10)(Up to Day 26)
  • C-reactive protein(Up to Day 26)
  • Neutrophils(Up to Day 26)
  • Sleep efficiency(Up to Day 26)
  • Sleep latency(Up to Day 26)
  • Time asleep(Up to Day 26)
  • Protein carbonyls(Up to Day 26)
  • Slow myosin(Up to Day 26)
  • Interleukin 6 (IL-6)(Up to Day 26)
  • Creatine kinase(Up to Day 26)
  • F2-isoprostanes(Up to Day 26)
  • Limb Girth(Up to Day 26)
  • Fast myosin(Up to Day 26)
  • Range of motion (ROM) assessment(Up to Day 26)
  • Matrix metalloproteinase-9(Up to Day 26)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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