Clinical trial NCT05982665: Effect of Inhaled Molecular Hydrogen on Recovery Process After Downhill Walking on the Treadmill
Official title: Effect of Inhaled Molecular Hydrogen on Recovery Process After Downhill Walking on the Treadmill. A Randomized, Double-blind, Placebo-controlled Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Soreness
Muscle Fatigue
Oxidative Stress
Inflammation
Lead sponsor: Palacky University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 14
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Creatine kinase
timeFrame: Change between values before and after 4 weeks of crossover.
measure: Perceived muscle soreness
timeFrame: Change between values before and after 4 weeks of crossover.
Secondary outcomes:
measure: Reactive strength index
timeFrame: Change between values before and after 4 weeks of crossover.
measure: Malondialdehydes
timeFrame: Change between values before and after 4 weeks of crossover.
measure: Interleukin-6
timeFrame: Change between values before and after 4 weeks of crossover.
Other outcomes:
measure: Heart rate
timeFrame: Change between values before and after 4 weeks of crossover.
measure: Ventilation
timeFrame: Change between values before and after 4 weeks of crossover.
measure: Oxygen uptake
timeFrame: Change between values before and after 4 weeks of crossover.
measure: Blood lactate
timeFrame: Change between values before and after 4 weeks of crossover.
measure: Rating of perceived exertion
timeFrame: Change between values before and after 4 weeks of crossover.
Locations:
city: Olomouc
country: Czechia
facility: Palacky University, Faculty of Physical Culture
Study officials:
affiliation: Palacky University, Faculty of Physical Culture
name: Adam Jarmar, Mgr
role: PRINCIPAL_INVESTIGATOR
References: