- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07625696
Study on the Effect of Hyperbaric Oxygen Intervention on Relieving Sports Fatigue of Sailors
- Research Purpose Intensive training often causes autonomic nerve imbalance, poor microcirculation and slow fatigue recovery in elite sailing athletes. This study adopted 1.3 ATA mild hyperbaric oxygen with 28% oxygen concentration for a 6-week intervention. It aimed to explore whether mild hyperbaric oxygen can improve athletes' autonomic nerve function, microcirculation and fatigue-related biochemical indicators. Meanwhile, it intended to estimate the effect size, provide basis for future large-scale formal trials, and optimize fatigue recovery strategies for sailing athletes and other endurance athletes.
Study Population A total of 16 elite male sailing athletes were enrolled and randomly divided into two groups with 8 participants in each group.
Inclusion criteria: aged over 18 years; holding national first-class athlete certificate or above; participating in systematic sailing training at least 5 times a week with more than 5 years of professional training experience.
Those with cardiovascular diseases, absolute contraindications to hyperbaric oxygen, training suspension due to injury and other ineligible conditions were excluded.
- Primary Outcome Measures Autonomic nerve function: Heart rate variability (HRV) indicators were tested to observe whether hyperbaric oxygen balances sympathetic and parasympathetic nerves and relieves training-induced autonomic disorder.
Microcirculation function: Measured muscle microcirculation blood flow velocity, capillary perfusion and thermal stimulation microvascular reserve capacity to evaluate the improvement of peripheral blood circulation.
Fatigue and biochemical biomarkers:
Routine blood indexes: red blood cell, hemoglobin, white blood cell; Exercise injury and metabolic indexes: creatine kinase (CK), blood urea nitrogen (BUN), testosterone and cortisol; Oxidative stress indexes: malondialdehyde (MDA), superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GSH-Px), to assess the body's oxidation-antioxidant status, inflammation level and fatigue recovery degree.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: jin yu
- Phone Number: +86 18101732823
- Email: 759559257@qq.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male elite sailing athletes aged 18-35 years
- Holding a national first-class athlete certificate or above
- With at least 5 years of professional sailing training experience
- Engaging in regular sailing training ≥ 5 times per week
- Voluntarily sign the informed consent form
Exclusion Criteria:
- - Presence of cardiovascular, respiratory, or neurological diseases
- Absolute contraindications to hyperbaric oxygen therapy
- Current injury or illness requiring medical treatment or training suspension
- Use of any medications or supplements that may affect fatigue recovery or autonomic function
- Participation in other concurrent recovery interventions during the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mild Hyperbaric Oxygen Intervention Group
|
Participants receive mild hyperbaric oxygen therapy (mHBOT) in a hyperbaric chamber at 1.3 atmospheres absolute (ATA) with 28% oxygen concentration, for 60 minutes per session, 5 sessions per week over 6 weeks.
All participants continue their standard sailing training regimen throughout the study.
|
|
No Intervention: Control Group (No Hyperbaric Oxygen)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Heart Rate Variability (HRV)
Time Frame: Baseline (Week 0), Post-intervention (Week 6)
|
Baseline (Week 0), Post-intervention (Week 6)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LLSC20250004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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