Muscle SorenessNCT05982665
Effect of Inhaled Molecular Hydrogen on Recovery Process After Downhill Walking on the Treadmill
A study testing Molecular hydrogen in people with Muscle Soreness and Muscle Fatigue, run by Palacky University at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Soreness, Muscle Fatigue, Oxidative Stress
- What is being tested?
- Molecular hydrogen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteCzechia
- Study dates
- 14 Aug 2023to 29 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Free of major diseases.
- Completed questionnaire Sudden Cardiovascular Death in Sport: Lausanne Recommendations.
- Signed informed consent.
Who cannot join
- Acute conditions contraindicating laboratory testing of sports performance.
- Hypertension.
- Dyslipoproteinaemia.
- Cardiorespiratory disease.
- Pharmacotherapy affecting heart rate.
- Musculoskeletal problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscle Soreness, Muscle Fatigue, Oxidative Stress, Inflammation
- Being tested
- Molecular hydrogen, Placebo
- Medical subject headings
- Myalgia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular hydrogenOther
Also called i300 Hydrogen Generator, H2 World Health & Beauty Company, Ostrava, Czech Republic
Hydrogen gas, purity >99.9%, flow rate 300 ml/min.
PlaceboOther
Also called i300 Placebo Generator, H2 World Health & Beauty Company, Ostrava, Czech Republic
Ambient air, flow rate 300 ml/min.
| Study group | Role | What they receive |
|---|---|---|
| Molecular hydrogen | Experimental | 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. Receives: Other: Molecular hydrogen |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change between values before and after 4 weeks of crossover.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Change between values before and after 4 weeks of crossover.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start14 Aug 2023
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SorenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palacky University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakub Krejci, Palacky University
- Investigators
- Adam Jarmar, Mgr, Principal investigator, Palacky University, Faculty of Physical Culture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982665
- Sponsor's protocol ID
- FTK_2023_12
- Status last verified
- Nov 2023
- First submitted
- 30 Jul 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised raw data will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inhaled Molecular Hydrogen on Recovery Process After Downhill Walking on the Treadmill. A Randomized, Double-blind, Placebo-controlled Crossover Study
- ClinicalTrials.gov ID
- NCT05982665
- Acronym / sponsor ID
- FTK_2023_12
- Conditions
- Muscle Soreness, Muscle Fatigue, Oxidative Stress, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Palacky UniversityUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Molecular hydrogen | Experimental | Other: Molecular hydrogenMolecular 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 | Placebo comparator | Other: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Free of major diseases.
- Completed questionnaire Sudden Cardiovascular Death in Sport: Lausanne Recommendations.
- Signed informed consent.
Key exclusion criteria (6 listed)
- Acute conditions contraindicating laboratory testing of sports performance.
- Hypertension.
- Dyslipoproteinaemia.
- Cardiorespiratory disease.
- Pharmacotherapy affecting heart rate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular hydrogenAlso: i300 Hydrogen Generator, H2 World Health & Beauty Company, Ostrava, Czech RepublicHydrogen gas, purity >99.9%, flow rate 300 ml/min. | Other | Molecular hydrogen |
| PlaceboAlso: i300 Placebo Generator, H2 World Health & Beauty Company, Ostrava, Czech RepublicAmbient air, flow rate 300 ml/min. | Other | Placebo |
Primary outcome
Creatine kinase
Time frame: 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
Time frame: 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.
3 secondary outcomes
Reactive strength index
Time frame: Change between values before and after 4 weeks of crossover.
Malondialdehydes
Time frame: Change between values before and after 4 weeks of crossover.
Interleukin-6
Time frame: Change between values before and after 4 weeks of crossover.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: Yes. Anonymised raw data will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Jarmar, Mgr principal investigator
Palacky University, Faculty of Physical Culture
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Molecular hydrogen in people with Muscle Soreness and Muscle Fatigue, run by Palacky University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creatine kinase (time frame: Change between values before and after 4 weeks of crossover.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.