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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05982665
• Other study ID #: FTK_2023_12
• Status: Completed
• Phase: N/A
• Start date: August 14, 2023
• Est. completion date: November 29, 2023

Study information

• Verified date: November 2023
• Source: Palacky University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Muscle Fatigue
• Muscle Soreness
• Myalgia
• Oxidative Stress

Intervention

Other:
• Molecular hydrogen
Hydrogen gas, purity >99.9%, flow rate 300 ml/min.
• Placebo
Ambient air, flow rate 300 ml/min.

Locations

Country	Name	City	State
Czechia	Palacky University, Faculty of Physical Culture	Olomouc

Sponsors (1)

Lead Sponsor	Collaborator
Palacky University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.