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CTRI Number  CTRI/2025/11/097526 [Registered on: 17/11/2025] Trial Registered Prospectively
Last Modified On: 14/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [HYPERBARIC OXYGEN THERAPY]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   Evaluating the Effectiveness of Hyperbaric Oxygen Therapy Combined with Standard Recovery Methods on Post-Marathon Recovery Outcomes in Elite Endurance Athletes of Manipur 
Scientific Title of Study   Effectiveness of combined hyperbaric oxygen therapy and standard recovery method in comparison with standard recovery method alone on post-marathon recovery in elite endurance athletes of Manipur: A cross-over randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sharangthem Kishan Singh 
Designation  Post Graduate Student 
Affiliation  Regional Institute of Medical Sciences, Imphal 
Address  Department of Sports Medicine, Regional Institute of Medical Sciences, Imphal, Manipur

Imphal West
MANIPUR
795004
India 
Phone  7005240263  
Fax    
Email  shkishan18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Yumnam Ningthemba Singh 
Designation  Associate Professor and Head I/C, Department of Sports Medicine, RIMS, Imphal  
Affiliation  Regional Institute of Medical Sciences, Imphal 
Address  Department of Sports Medicine, Regional Institute of Medical Sciences, Imphal, Manipur

Imphal West
MANIPUR
795004
India 
Phone  8787548001  
Fax    
Email  yningthemba@gmail.com  
 
Details of Contact Person
Public Query  
Name  Yumnam Ningthemba Singh 
Designation  Associate Professor and Head I/C, Department of Sports Medicine, RIMS, Imphal  
Affiliation  Regional Institute of Medical Sciences, Imphal 
Address  Department of Sports Medicine, Regional Institute of Medical Sciences, Imphal, Manipur

Imphal West
MANIPUR
795004
India 
Phone  8787548001  
Fax    
Email  yningthemba@gmail.com  
 
Source of Monetary or Material Support  
REGIONAL INSTITUTE OF MEDICAL SCIENCES, IMPHAL - 795004, MANIPUR, INDIA 
 
Primary Sponsor  
Name  SHARANGTHEM KISHAN SINGH 
Address  Department of Sports Medicine, Regional Institute of Medical Sciences, Imphal - 795004, Manipur, India 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SHARANGTHEM KISHAN SINGH  REGIONAL INSTITUTE OF MEDICAL SCIENCES  Department of Sports Medicine/OPD division/room no. 1
Imphal West
MANIPUR 		 7005240263

shkishan18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RESEARCH ETHICS BOARD RIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ACTIVE MARATHON RUNNENS AGED 18 TO 35 YEARS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HYPERBARIC OXYGEN THERAPY along with STANDARD RECOVERY METHOD  hyperbaric oxygen therapy is a safe, effective, and non-invasive treatment, with its various mechanism of action, has been reported to be beneficial in accelerating cell recovery and tissue repair, which are considered to help eliminate fatigue, recover stamina and restore endurance capacity. Each participant will be undergoing one session of HBOT lasting 1 hour and 40 minutes on the same day of marathon. 
Comparator Agent  STANDARD RECOVERY METHOD  Include a comprehensive multi-phase approach with proper nutrition, hydration, sleep and both active and passive recovery following the completion of marathon 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Active marathon runners of Manipur aged 18 to 35 years 
 
ExclusionCriteria 
Details  Includes uncontrolled systemic diseases, pneumothorax, claustrophobia, respiratory insufficiency, ET tube dysfunction, sinusitis, middle ear dysfunction, recent ear/chest surgery 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. biochemical markers (serum lactate, creatine kinase, C-reactive protein, lactate dehydrogenase, SGOT, blood sugar, haemoglobin%, total RBC)
2. pain intensity and interference (measured by Brief pain inventory)
3. resting heart rate 		 Day X (baseline data will be collected after at least 24 hours of rest)
Day 1 (data collection following marathon run)
Since the the study is Cross-over design, after a washout period of 45 days, same data collection for outcome measures will be done. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Marathon is a long-distance foot race of 42.195 kilometres or 26.2 miles, usually run as a road race. For elite endurance athletes, this distance is usually covered within 2 hours and 30 minutes. Marathon running elicits a wide range of physical, physiological, and biochemical responses throughout the body. All these responses can be alleviated by standard recovery method and it usually takes several weeks ,around 3 to 4 weeks, to achieve complete recovery using this method. However, early recovery is crucial for elite athletes who are regularly exposed to high-stress training and competition. Therefore, an adjuvant to the standard recovery method is desired to shorten the recovery time. In recent years, HBOT has gained considerable attention among Sports Medicine specialists as an adjuvant therapy to accelerate athletes’ muscular injury recovery, but the exact effectiveness remains unclear and limited studies in India and no published literature in Northeast India including Manipur, hence this cross-over randomized controlled trial will be conducted to determine the effectiveness of combined hyperbaric oxygen therapy and standard recovery method in comparison with standard recovery method alone on post-marathon recovery in elite endurance athletes. A sample size of 52 participants will be recruited using consecutive sampling which will be randomized into group A and group B. Outcomes will be measured using serum biochemical markers, Resting Heart Rate RHR and Brief Pain Inventory BPI at baseline and post-marathon day 1 following interventions with respect to the groups allotted. Descriptive statistics such as mean, percentages, SD and analytical statistics such as Chi-square test, student t-test and Paired t-test will be used and a p-value less than 0.05 will be taken as significant. Ethical clearance will be sought from the Research Ethics Board, Regional Institute of Medical Sciences, Imphal. 
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