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临床试验/NCT06485063
NCT06485063招募中不适用

Effects of Myofascial Reorganization on Running Performance, and Lower Limb Biomechanical, Viscoelastic, and Thermographic Properties of Triathletes: a Randomized Clinical Trial.

University of the State of Santa Catarina2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Maximal velocity

研究概览

简要总结

This is a two-group randomized clinical trial (includes an experimental and a placebo group) to verify the effects of the Myofascial Reorganization (RMF) compared to the placebo-RMF technique on running performance and thermographic, biomechanical, and viscoelastic proprieties of lower limbs of male triathletes. Data collection will be carried out one week before the first intervention session, and one week after the last intervention session. Anthropometric characteristics (height and weight), lower limbs, and biomechanical, viscoelastic, and thermographic properties will be collected before any exercise tests. After this, the athlete will be submitted to: a 10-minute protocol to verify running economy on the treadmill, followed by an incremental test on the treadmill, and a time to exhaustion test. Evaluation procedures will carried out one week before (0 weeks) and one week after (7th week) the experimental/placebo intervention. Intervention sessions will occur during six weeks, twice a week, each session lasting up to 30 minutes.

详细描述

1. This study was approved by the Ethical Committee involving Research with Human Beings of the University of Santa Catarina (UDESC) under protocol number 56498722.1.0000.0118. Consolidated Standards of Reporting Trials will be followed.

2.1 General objectives: to verify the effects of the Myofascial Reorganization (RMF) technique compared to the placebo-RMF technique on running performance and thermographic, biomechanical, and viscoelastic proprieties of lower limbs of athletes.

2.2 Specific objectives: intragroup and intergroup comparisons of running-related performance variables, lower limb skin temperature, and biomechanical and viscoelastic properties.

3. Sample: Athletes volunteers living in Florianópolis, SC, Brazil, if they meet inclusion criteria and do not meet exclusion criteria.

4. Sampling: will be non-probabilistic by convenience and snowball (participants will be recruited by social media, flyers, and by referral of other participants).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants will be blinded to which group they will belong, as they never had contact to the technique investigated. The statistical analysis will be blinded as well, and the statistical will not know which is the experimental or the placebo group.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 45 years
  • 2 years of competitive experience
  • Non-smokers
  • Training at least 3 times/week intending to compete in at least local competitions
  • No presenting lower limb surgery in the last 12 months
  • Not presenting lower limb injury in the last 6 months
  • Not presenting cerebellar diseases that limit sportive practice
  • Not presenting brain diseases that limit sportive practice
  • Not presenting musculoskeletal diseases that limit sportive practice
  • Not presenting signs of rhabdomyolysis
  • Not presenting systemic conditions that limit sportive practice
  • Not presenting metabolic that limits sports practice
  • Not presenting autoimmune conditions;
  • Not presenting cardiac conditions.

排除标准

  • Not accomplishing 83,3% (10 of 12 sessions) of the proposed experimental/placebo protocol
  • Not presenting themselves on the re-test day
  • Developing a lower limb musculoskeletal injury during the study's ongoing period.
  • Developing a back injury during the study's ongoing period?
  • Developing central or peripheral nervous system conditions during the study's ongoing period.

结局指标

主要结局

Maximal velocity

时间窗: Pre-intervention (0 week time point) and post-intervention (7 week time point)

maximal velocity derived from the incremental graded test

Running Economy

时间窗: Pre-intervention (0 week time point) and post-intervention (7 week time point)

the volume consumption of oxygen (VO2) required at a common velocity under the first lactate threshold in milliliters per minute per kilogram (mL.min-1.Kg-1).

Time to Exhaustion

时间窗: Pre-intervention (0 week time point) and post-intervention (7 week time point)

Time to volitional exhaustion during the Time to Exhaustion Test, running at 100% of the last velocity reached in the incremental test, in minutes and seconds.

Maximal volume consumption of oxygen

时间窗: Pre-intervention (0 week time point) and post-intervention (7 week time point)

The maximal volume consumption of oxygen (VO2max) in milliliters per minute per kilogram (mL.min-1.Kg-1) will be determined as the highest value reached in the last stage plotted employing means of 15 seconds.

次要结局

  • Dynamic Stiffness (N/m);(Pre-intervention (0 week time point) and post-intervention (7 week time point))
  • State of tension: F - Frequency or TONE(Pre-intervention (0 week time point) and post-intervention (7 week time point))
  • Second lactate threshold(Pre-intervention (0 week time point) and post-intervention (7 week time point))
  • R- Relaxation time(Pre-intervention (0 week time point) and post-intervention (7 week time point))
  • First lactate threshold(Pre-intervention (0 week time point) and post-intervention (7 week time point))
  • D -logarithmic decrement(Pre-intervention (0 week time point) and post-intervention (7 week time point))
  • C - Creep(Pre-intervention (0 week time point) and post-intervention (7 week time point))

研究者

发起方
University of the State of Santa Catarina
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gilmar Moraes Santos, PT

Principal Investigator

University of the State of Santa Catarina

研究点 (2)

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