Effect of Inhaled Molecular Hydrogen on Recovery Process After Downhill Walking on the Treadmill

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Oxidative Stress; Muscle Soreness; Muscle Fatigue
• Intervention / Treatment: Other: Molecular hydrogen; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Olomouc, Czechia, 77111
    • Palacky University, Faculty of Physical Culture

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Molecular hydrogen; Molecular hydrogen inhalation for 60 min at 48 h, 24 h, and 60 min pre-exercise and for 30 min post-exercise and 24 h post exercise.	Other: Molecular hydrogen; Hydrogen gas, purity >99.9%, flow rate 300 ml/min.; Other Names: i300 Hydrogen Generator, H2 World Health & Beauty Company, Ostrava, Czech Republic
Placebo Comparator: Placebo; Placebo inhalation for 60 min at 48 h, 24 h, and 60 min pre-exercise and for 30 min post-exercise and 24 h post exercise.	Other: Placebo; Ambient air, flow rate 300 ml/min.; Other Names: i300 Placebo Generator, H2 World Health & Beauty Company, Ostrava, Czech Republic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creatine kinase	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.	Change between values before and after 4 weeks of crossover.
Perceived muscle soreness	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.	Change between values before and after 4 weeks of crossover.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reactive strength index	Reactive strength index is determined in 5 maximum hop test on AMTI OR6-7-1000 force platform (Advanced Mechanical Technology, Watertown, USA). Each subject is instructed to maximize the jump height and minimize the ground contact time. Reactive strength index is measured pre-exercise (baseline), post-exercise, and 2 h, 24 h and 48 h post-exercise.	Change between values before and after 4 weeks of crossover.
Malondialdehydes	The level of malondialdehydes 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 post-exercise. Malondialdehydes are determined using TBARS assay kit according to the manufacturer's instructions.	Change between values before and after 4 weeks of crossover.
Interleukin-6	The level of Interleukin-6 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 post-exercise. Interleukin-6 is determined by ELISA method according to the manufacturer's instructions.	Change between values before and after 4 weeks of crossover.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate during the 90 min exercise is continuously recorded by Polar V800 heart rate monitor (Polar, Kempele, Finland).	Change between values before and after 4 weeks of crossover.
Ventilation	Ventilation (air flow into and out of the lungs expressed in L/min) is measured with Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the exercise and averaged over 5 min windows for subsequent analysis.	Change between values before and after 4 weeks of crossover.
Oxygen uptake	Oxygen uptake is measured with Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the exercise and averaged over 5 min windows for subsequent analysis.	Change between values before and after 4 weeks of crossover.
Blood lactate	The level of blood lactate is measured from the fingertip blood sample using Lactate Scout+ analyser (EKF Diagnostics, Cardiff, UK) pre-exercise (baseline) and at specified time points (30, 60, and 90 min) during the exercise.	Change between values before and after 4 weeks of crossover.
Rating of perceived exertion	Subjects are asked to subjectively rate their perceived exertion at specified time points (30, 60, and 90 min) during the exercise. The Borg's scale 6 (no exertion at all) and 20 (maximal exertion) is used.	Change between values before and after 4 weeks of crossover.

Collaborators and Investigators

• Sponsor: Palacky University
• Investigators: Principal Investigator: Adam Jarmar, Mgr, Palacky University, Faculty of Physical Culture

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2023
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: July 30, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia; Inflammation
• Other Study ID Numbers: FTK_2023_12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised raw data will be made available.
• IPD Sharing Time Frame: The data will be available once the results are published in a scientific journal.
• IPD Sharing Access Criteria: For everybody.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No