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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Dr Wen-Yi Chou
Public

123 Ta Pei Road, Niao Sung
Kaohsiung
83301
Taiwan

ORCID ID	0000-0002-8400-3457
Phone	+886-7-7317123
Email	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 objectives	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
Health condition(s) or problem(s) studied	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
Completion 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
Key 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
Key exclusion criteria	1. Pneumothorax 2. Upper respiratory tract infection 3. Recently received chest or ear surgery 4. Claustrophobic
Date of first enrolment	07/07/2014
Date of final enrolment	11/09/2015

Locations

Countries of recruitment

Taiwan

Study participating centre

Kaohsiung Chang Gung Memorial Hospital

123, Ta Pei Road, Niao Sung District
Kaohsiung
83301
Taiwan

Sponsor information

Chang Gung Memorial Hospital
Hospital/treatment centre

123 Ta Pei Road, Niao Sung District
Kaohsiung
83301
Taiwan

Phone	+886-7-7317123 ext 2450
Email	abc@email.com
Website	http://www.cgmh.org.tw
"ROR"	https://ror.org/02verss31

Funders

Funder type

Hospital/treatment centre

Chang Gung Medical Foundation
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.