Can breathing pure oxygen at high pressure improve exercise-induced muscle injury recovery in baseball players?
| ISRCTN | ISRCTN17817041 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17817041 |
| Secondary identifying numbers | Chang Gung Research Fund grant CMRPG8D0411 |
- Submission date
- 14/03/2019
- Registration date
- 22/03/2019
- Last edited
- 11/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
Contact information
Public
123 Ta Pei Road, Niao Sung
Kaohsiung
83301
Taiwan
 ORCID ID |
0000-0002-8400-3457 |
|---|---|
| Phone | +886-7-7317123 |
| murraychou@yahoo.com.tw |
Study information
| Study design | Prospective randomized double-blind controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Hyperbaric oxygen therapy influence of high-intensity athletes in vivo metabolic indicators |
| Study hypothesis | HBOT could facilitate the early recovery of exercise-related muscular injury and could therefore be beneficial for elite athletes. |
| Ethics approval(s) | 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 |
| 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 |
| 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 study start date | 21/08/2013 |
| Overall study end date | 19/08/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 46 (5 cases loss) |
| Total final enrolment | 41 |
| 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 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
Study participating centre
Kaohsiung
83301
Taiwan
Sponsor information
Hospital/treatment centre
123 Ta Pei Road, Niao Sung District
Kaohsiung
83301
Taiwan
| Phone | +886-7-7317123 ext 2450 |
|---|---|
| abc@email.com | |
| Website | http://www.cgmh.org.tw |
"ROR" |
https://ror.org/02verss31 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- Taiwan
Results and Publications
| Intention to publish date | 30/08/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analyzed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 29/05/2019 | 11/02/2020 | Yes | No |
Editorial Notes
11/02/2020: Publication reference added.
29/03/2019: Internal review.
21/03/2019: Trial's existence confirmed by Chang Gung Medical Foundation.
