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临床试验/NCT05982665
NCT05982665已完成不适用

Effect of Inhaled Molecular Hydrogen on Recovery Process After Downhill Walking on the Treadmill. A Randomized, Double-blind, Placebo-controlled Crossover Study

Palacky University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2023年8月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Creatine kinase

研究概览

简要总结

This study assesses the effect of molecular hydrogen inhalation in healthy males on muscle soreness, fatigue, oxidative stress, and inflammation following eccentric muscle contraction during downhill walking on the treadmill.

详细描述

The main aim of this randomized, double-blind, placebo-controlled crossover study is to assess the effect of molecular hydrogen inhalation on recovery after downhill walking with an additional load of 15% of body mass on the treadmill with a negative slope of -15% at a speed of 6.5 km/h for 90 min. The study includes 12 participants, healthy males aged 20-35 years. The study consists of two experimental sessions, one using molecular hydrogen inhalation and the other using placebo inhalation. Randomization is performed using a computer random generator. Molecular hydrogen is colourless, odourless, and tasteless, so it cannot be distinguished from placebo by the human senses. The washout period between sessions is set at four weeks. One week before each session, participants are asked to follow diet and physical activity rules. Variables measured during the 48 h recovery are as follow: creatine kinase level, perceived muscle soreness, reactive strength index, malondialdehydes level, and interleukin-6 level. The following variables are also measured during exercise: heart rate, ventilation and gas exchange, and blood lactate level. Analysis of variance for repeated measures and Fisher's post hoc tests are used for statistical analysis. The significance level is set at 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

盲法说明

Hydrogen and placebo generators indistinguishable to the human senses

入排标准

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

入选标准

  • Free of major diseases.
  • Completed questionnaire Sudden Cardiovascular Death in Sport: Lausanne Recommendations.
  • Signed informed consent.

排除标准

  • Acute conditions contraindicating laboratory testing of sports performance.
  • Hypertension.
  • Dyslipoproteinaemia.
  • Cardiorespiratory disease.
  • Pharmacotherapy affecting heart rate.
  • Musculoskeletal problems.

结局指标

主要结局

Creatine kinase

时间窗: Change between values before and after 4 weeks of crossover.

The level of creatine kinase is measured from a venous blood sample taken by a healthcare specialist. Samples are collected in 2.7 ml citrate vacuum tubes. Samples are immediately centrifuged at 1000 g for 15 min and then divided into 0.5 ml cryotubes and frozen at -80 °C. Samples are taken pre-exercise (baseline), post-exercise, and 2 h, 24 h and 48 h post-exercise. Creatine kinase is determined by ELISA method according to the manufacturer's instructions.

Perceived muscle soreness

时间窗: Change between values before and after 4 weeks of crossover.

A visual analogue scale is used to subjectively assess lower limb muscle soreness. The visual analogue scale is represented by a 100 mm line marked 0 - no pain and 100 - worst imaginable pain. The subject is instructed to mark a point on the line corresponding to their perceived muscle soreness. Muscle soreness is assessed pre-exercise (baseline), post-exercise, and 2 h, 24 h and 48 h post-exercise.

次要结局

  • Malondialdehydes(Change between values before and after 4 weeks of crossover.)
  • Reactive strength index(Change between values before and after 4 weeks of crossover.)
  • Interleukin-6(Change between values before and after 4 weeks of crossover.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jakub Krejci

Assistant professor

Palacky University

研究点 (2)

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