Using oxygen to improve exercise performance in patients with cystic fibrosis

ISRCTN ISRCTN13864650
DOI https://doi.org/10.1186/ISRCTN13864650
Secondary identifying numbers 001/2008
Submission date
22/06/2019
Registration date
16/07/2019
Last edited
23/10/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Previous studies have shown that aerobic exercise training provides many benefits for patients with cystic fibrosis (CF). For example, it is known to improve survival and quality of life. However, it is still not known what type of exercise training (such as aerobic or strength), and what frequency, time spent, and intensity of training will increases these benefits.
High-intensity interval training (HIIT) is an excellent form of training because it does not require a great deal of time to do it. Also, because the exercise is done at a high intensity for a short time, it does not put a lot of strain on the respiratory system (compared to other types of exercise). This is particularly important for cystic fibrosis patients because they have problems with their respiratory system.
We wanted to find out if the addition of oxygen during the training sessions would improve the length of the high-intensity session, and therefore improve the benefit of the exercise training.

Who can participate?
Patients with cystic fibrosis aged 18 years or older

What does the study involve?
Participants perform HIIT on a cycle ergometer two days per week for eight weeks. Each exercise session is about 60 minutes in duration. During the exercise, some participants will be supplemented with oxygen however, the participants will not be told this. Over the study period, the training sessions will become longer as fitness improves.

What are the possible benefits and risks of participating?
Benefits: Each patient receives a written report outlining the principle findings of the study and a brief summary of the results of his/her own tests.
Risks: Exercise testing carries a very small risk of abnormal heart rhythms, heart attack, or death in less than one in 30,000 patients. The exercise tests are carried out by experienced exercise scientists and are supervised by a medical doctor. The participant may experience some muscle soreness in his/her legs or nausea following the maximal exercise test.

Where is the study run from?
Beaumont Hospital, Dublin, Ireland

When is the study starting and how long is it expected to run for?
May 2009 to June 2010

Who is funding the study?
Cystic Fibrosis Hopesource Foundation in Ireland

Who is the main contact?
Dr Ronen Reuveny
ronenreuveny@tauex.tau.ac.il

Contact information

Dr Ronen Reuveny
Scientific

Pulmonary institute
Sheba Medical Center
Tel-HaShomer
Ramat Gan
52621
Israel

Phone 972-3-5302930
Email ronenreuveny@tauex.tau.ac.il

Study information

Study designInterventional single center randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet No participant information sheet available
Scientific titleHigh-intensity interval training (HIIT) accelerates oxygen uptake kinetics and improves exercise tolerance for individuals with cystic fibrosis – a pilot study
Study acronymSOETBCF
Study objectives1. High-intensity interval training HIIT would reduce the VO2 mean response time (MRT) during CWR exercise
2. HIIT would increase the time to limit of tolerance during CWR exercise
3. Supplementation with O2 during HIIT would allow for more high-intensity work to be performed thereby resulting in amplification of the aforementioned training effects.
Ethics approval(s)Approved 12/03/2008 Ethics (Medical Research) Committee - Beaumont Hospital Dublin (Gillian Vale,
RCSI Beaumont Ethics, Royal College of Surgeons in Ireland Beaumont Hospital, Beaumont, Dublin 9 Ireland; 01-8092680; gvale@rcsi.ie), ref: 07/83
Health condition(s) or problem(s) studiedCystic fibrosis
InterventionThis pilot study employed a randomised, single-blind design. Participants were randomly assigned to a group performing HIIT with O2 supplementation (O2+) or a group performing HIIT while breathing ambient air (AMB). Participants blinded to the treatment performed HIIT on a cycle ergometer two days per week for eight weeks. Each exercise session was about 60 minutes in duration.

Patients with CF were randomly assigned to a group performing high-intensity interval training with oxygen supplementation or to a group performing high-intensity interval training while breathing ambient air. Each patient chose a piece of paper from an envelope, which indicated which group they were assigned to.

Participants visited the exercise lab on three separate days before (baseline) and after the training program (12 weeks). Each visit was at least 72 hours apart. During these visits, participants performed the pre- and post-training evaluations which consisted of: Anthropometric measurements, Pulmonary function tests, Maximal exercise capacity test, VO2 kinetics.

Maximal exercise capacity test: Participants performed an incremental symptom-limited peak exercise test on an electronically-braked cycle ergometer while breathing through a full face mask. The incremental protocol was designed to ensure that participants reached limit of tolerance within 8–12 minutes. Gas-exchange data was collected during the test and measurements of O2 consumption, CO2 production, heart rate, ventilation and respiratory rate were obtained.
During the second visit, participants performed a constant work cycling test at 30% the peak work rate achieved on the incremental maximal test. Gas-exchange data were collected during the test and measurements of VO2 kinetics, CO2 production, heart rate, ventilation and respiratory rate were obtained.
During the third visit, participants performed a constant work cycling test at 70% the peak work rate achieved on the incremental maximal test. Gas-exchange data was collected during the test and measurements of VO2 kinetics, CO2 production, heart rate, ventilation and respiratory rate were obtained.
Intervention typeSupplement
Primary outcome measureMaximal exercise capacity measured using an incremental symptom-limited peak exercise test on an electronically-braked cycle ergometer while breathing through a full face mask measured at baseline and 12-weeks.
Secondary outcome measures1. Anthropometric measurements: height and body mass were measured and double thickness subcutaneous adipose tissue was determined on the right side of the body using skinfold calipers, at the first visit.
2. Pulmonary function tests: spirometry and single-breath carbon monoxide diffusion capacity were measured at the first visit.
Overall study start date09/11/2007
Completion date04/07/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants11
Total final enrolment9
Key inclusion criteria1. Diagnosis of CF that was based on clinical features, sweat test, or genotyping, and a pulmonary function test
2. Age > 18 years
3. Forced expiratory in one second (FEV1) > 30% predicted
4. Clinically stable
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment15/05/2009
Date of final enrolment04/06/2010

Locations

Countries of recruitment

  • Ireland

Study participating centre

Beaumont Hospital
P.O. Box 1297
Beaumont Road
Dublin
D9
Ireland

Sponsor information

School of Health and Human Performance, Dublin City University
University/education

Glasnevin, Dublin 9
Dublin
D9
Ireland

Phone +353 1 700 7411
Email international.office@dcu.ie
Website international.office@dcu.ie
ROR logo "ROR" https://ror.org/04a1a1e81

Funders

Funder type

Charity

Cystic Fibrosis Hopesource Foundation in Ireland

No information available

Results and Publications

Intention to publish date10/07/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planWe are going to submit it in a special review "Application of high-intensity training methods in clinical populations - concepts, progress, and challenges" in Sports Science, Medicine and Rehabilitation journal in BMC open access.
IPD sharing planAll data generated or analysed 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 13/04/2020 23/10/2020 Yes No

Editorial Notes

23/10/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
27/08/2019: Internal review.
15/07/2019: Trial’s existence confirmed by Ethics (Medical Research) Committee - Beaumont Hospital