Placebo effect during sprint training in simulated altitude
| ISRCTN | ISRCTN20250468 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20250468 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | IRB-EM 2201C |
| Sponsor | EuroMov Digital Health in Motion |
| Funder | Université de Montpellier |
- Submission date
- 18/02/2025
- Registration date
- 25/03/2025
- Last edited
- 25/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Repeated sprint training in hypoxia (low oxygen levels) has been proposed to further enhance performance compared to the same training in normoxia (normal oxygen levels). Given the positive belief about hypoxic training, it is possible that performance may be artificially increased by a placebo effect. However, this has never been tested yet. This study proposes to compare the response to repeated sprint training between three groups of participants: a control group that trains in normoxia, an experimental group that trains in hypoxia and a placebo group that trains in normoxia but that was told that training was in hypoxia.
Who can participate?
Recreationally or well-trained participants aged over 18 years and below 30 years who are accustomed to repeated sprints during their personal practice
What does the study involve?
There are 13 visits of 45 minutes each on 7 consecutive weeks. Participants are allocated to control (normoxia), placebo (normoxia but told that they were in hypoxia) or hypoxia based on their personal performance on the pre-test session.
What are the possible benefits and risks of participating?
Potential benefits are an increase in physical fitness. Potential risks are fatigue due to the training session.
Where is the study run from?
Euromov Digital Health in Motion (France)
When is the study starting and how long is it expected to run for?
October 2021 to December 2022
Who is funding the study?
University of Montpellier (France)
Who is the main contact?
Dr François Favier, francois.favier@umontpellier.fr
Contact information
Public, Scientific, Principal investigator
700 avenue du Pic Saint Loup
Montpellier
34090
France
 ORCID ID |
0000-0002-9084-4797 |
|---|---|
| Phone | +33 (0)676832401 |
| francois.favier@umontpellier.fr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Monocenter interventional double-blinded randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Examining placebo effects after a three-week repeated-sprint training program under hypoxic conditions in recreationally trained subjects |
| Study acronym | OPTIPOXIE |
| Study objectives | 1. The belief of exercising in hypoxia leads to performance improvement because of the placebo effect 2. Training in hypoxia leads to further improvement compared to the placebo group |
| Ethics approval(s) |
Approved 02/03/2022, IRB EuroMov-Montpellier (700 avenue du Pic ST Loup, Montpellier, 34090, France; +33 (0)434432630; irb@euromov.eu), ref: IRB-EM 2201C |
| Health condition(s) or problem(s) studied | Effectiveness of repeated-sprint training in moderately trained subjects |
| Intervention | Participants were familiarized with the Wingate test in week 1. They were tested on Wingate and repeated sprint tests on week 2 (both tests being separated by 48 h). They were randomly balanced in a control (normoxia), placebo (normoxia but told that they were in hypoxia) or hypoxia group based on their personal performance (mean power output) on the pre-test session. They were subjected to two training sessions of repeated sprints per week for 3 weeks (weeks 3 to 5). They were tested twice on Wingate and repeated sprint tests (weeks 6 and 7), with 1 week between the same tests. |
| Intervention type | Other |
| Primary outcome measure(s) |
Mean power output measured on an ergocycle during testing sessions, i.e. at baseline, 1 and 2 weeks after training completion |
| Key secondary outcome measure(s) |
1. Heart rate measured by Polar H10 chest sensor during all training and testing sessions |
| Completion date | 16/12/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 33 |
| Key inclusion criteria | 1. Regular sport training + being accustomed to intense exercise such as repeated sprints 2. No intolerance to moderate hypoxia 3. No stay at altitudes above 1500 m in the previous 2 months 4. Aged over 18 years and below 30 years |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/04/2022 |
| Date of final enrolment | 01/09/2022 |
Locations
Countries of recruitment
- France
Study participating centre
Montpellier
34090
France
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The anonymized datasets generated during the current study will be available on reasonable request from Dr François Favier (francois.favier@umontpellier.fr) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/02/2025: Study's existence confirmed by IRB EuroMov-Montpellier.
