Plain English Summary
Background and study aims
Hyperbaric oxygen therapy (HBOT) involves a person breathing pure oxygen at higher pressure than normal air pressure. Air normally contains about 21% oxygen and 78% nitrogen, so HBOT provides more oxygen to the body than is normally breathed in. It is thought that HBOT might results in muscle injuries healing more quickly, which would be an advantage to those playing sport competitively or professionally. This study aims to investigate whether HBOT improved recovery of muscle soreness and strains caused by exercise in baseball players.
Who can participate?
Professional or amateur male baseball players in training or the baseball season who have a muscle injury caused by exercise.
What does the study involve?
The participants will be randomly allocated to one of two groups. Both groups will spend 10 sessions of 100 minutes over 5 weeks in a pressurised chamber, where the pressure will be raised to above normal. One group will breathe pure oxygen while in the chamber and the other will breathe normal air. Oxygen and nitrogen are colourless gases with no smell so the participants will not be able to tell which gas they are breathing. Before the first session, after the fifth session, after the last session and 2 weeks after the last session, the participants will be asked give a blood sample and to rate their muscle pain and how much it affects their daily activities.
What are the possible benefits and risks of participating?
Those who breathe pure oxygen might experience earlier recovery of the muscle injury. There is also a small risk of side effects caused by absorbing too much oxygen.
Where is the study run from?
Kaohsiung Chang Gung Memorial Hospital, Taiwan, Republic of China
When is the study starting and how long is it expected to run for?
August 2013 to August 2016
Who is funding the study?
Chang Gung Research Fund (Taiwan)
Who is the main contact?
Miss Chen-Yu Chen
Trial website
Contact information
Type
Public
Primary contact
Dr Wen-Yi Chou
ORCID ID
http://orcid.org/0000-0002-8400-3457
Contact details
123 Ta Pei Road
Niao Sung
Kaohsiung
83301
Taiwan
+886-7-7317123
murraychou@yahoo.com.tw
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Chang Gung Research Fund grant CMRPG8D0411
Study information
Scientific title
Hyperbaric oxygen therapy influence of high-intensity athletes in vivo metabolic indicators
Acronym
Study hypothesis
HBOT could facilitate the early recovery of exercise-related muscular injury and could therefore be beneficial for elite athletes.
Ethics approval
Approved 21/08/2013, Institutional Review Board (IRB) of Chang Gung Medical Foundation (123 Dinghu Rd, Guishan Township, Taoyuan County, Taiwan (R.O.C.); +886 3 3196200 ext 3707/3703; merlinchi@cgmh.org.tw), ref: 102-2994B
Study design
Prospective randomized double-blind controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Exercise-related muscular injury
Intervention
41 participants were recruited between June 2014 and December 2015 and were divided into study group and control group with 20 and 21 participants. All the participants received either HBOT or placebo sessions twice in a week. The study group and the control group stayed in a hyperbaric chamber pressurized to 2.5 and 1.3 atm, and breathed pure oxygen and general air, respectively. The duration of each session was 100 mins, and 10 sessions were completed in 5 weeks for each participant.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
1. Serum creatine phosphokinase (CPK)
2. Serum glutamic-oxaloacetic transaminase (GOT)
3. Serum myoglobin
4. Blood urine nitrogen (BUN)
5. Serum lactate
Data were collected before the treatment (T1), end of 5th HBOT (T2), end of 10th HBOT (T3), and 2 weeks after the 10th HBOT (T4).
Secondary outcome measures
1. Pain intensity assessed using the Brief Pain Inventory before the treatment (T1), end of 5th HBOT (T2), end of 10th HBOT (T3), and 2 weeks after the 10th HBOT (T4)
2. Pain interference assessed using the Brief Pain Inventory before the treatment (T1), end of 5th HBOT (T2), end of 10th HBOT (T3), and 2 weeks after the 10th HBOT (T4)
Overall trial start date
21/08/2013
Overall trial end date
19/08/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 20 years or older
2. Diagnosed with prolonged (more than 2 weeks) exercise-induced muscular soreness or pain with grade I muscle strain of the extremities
3. Currently under intensive and regular baseball training or regular baseball season
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
46 (5 cases loss)
Total final enrolment
41
Participant exclusion criteria
1. Pneumothorax
2. Upper respiratory tract infection
3. Recently received chest or ear surgery
4. Claustrophobic
Recruitment start date
07/07/2014
Recruitment end date
11/09/2015
Locations
Countries of recruitment
Taiwan
Trial participating centre
Kaohsiung Chang Gung Memorial Hospital
123, Ta Pei Road, Niao Sung District
Kaohsiung
83301
Taiwan
Sponsor information
Organisation
Chang Gung Memorial Hospital
Sponsor details
123 Ta Pei Road
Niao Sung District
Kaohsiung
83301
Taiwan
+886-7-7317123 ext 2450
abc@email.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Chang Gung Medical Foundation
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
Taiwan
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated and/or analyzed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
30/08/2019
Participant level data
Other
Basic results (scientific)
Publication list
2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31275980 (added 11/02/2020)