search
Back to results

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

Primary Purpose

Muscle Soreness, Muscle Fatigue, Oxidative Stress

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Molecular hydrogen
Placebo
Sponsored by
Palacky University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Muscle Soreness

Eligibility Criteria

20 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Palacky University, Faculty of Physical Culture

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Molecular hydrogen

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
July 30, 2023
Last Updated
August 21, 2023
Sponsor
Palacky University
search

1. Study Identification

Unique Protocol Identification Number
NCT05982665
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 14, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palacky University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Soreness, Muscle Fatigue, Oxidative Stress, Inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
Hydrogen and placebo generators indistinguishable to the human senses
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Molecular hydrogen
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Molecular hydrogen
Other Intervention Name(s)
i300 Hydrogen Generator, H2 World Health & Beauty Company, Ostrava, Czech Republic
Intervention Description
Hydrogen gas, purity >99.9%, flow rate 300 ml/min.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
i300 Placebo Generator, H2 World Health & Beauty Company, Ostrava, Czech Republic
Intervention Description
Ambient air, flow rate 300 ml/min.
Primary Outcome Measure Information:
Title
Creatine kinase
Description
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.
Time Frame
Change between values before and after 4 weeks of crossover.
Title
Perceived muscle soreness
Description
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.
Time Frame
Change between values before and after 4 weeks of crossover.
Secondary Outcome Measure Information:
Title
Reactive strength index
Description
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.
Time Frame
Change between values before and after 4 weeks of crossover.
Title
Malondialdehydes
Description
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.
Time Frame
Change between values before and after 4 weeks of crossover.
Title
Interleukin-6
Description
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.
Time Frame
Change between values before and after 4 weeks of crossover.
Other Pre-specified Outcome Measures:
Title
Heart rate
Description
Heart rate during the 90 min exercise is continuously recorded by Polar V800 heart rate monitor (Polar, Kempele, Finland).
Time Frame
Change between values before and after 4 weeks of crossover.
Title
Ventilation
Description
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.
Time Frame
Change between values before and after 4 weeks of crossover.
Title
Oxygen uptake
Description
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.
Time Frame
Change between values before and after 4 weeks of crossover.
Title
Blood lactate
Description
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.
Time Frame
Change between values before and after 4 weeks of crossover.
Title
Rating of perceived exertion
Description
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.
Time Frame
Change between values before and after 4 weeks of crossover.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Jarmar, Mgr
Organizational Affiliation
Palacky University, Faculty of Physical Culture
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palacky University, Faculty of Physical Culture
City
Olomouc
ZIP/Postal Code
77111
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs