Exercise TrainingNCT04366414
Breathing Protocol in Breath-hold Divers
A study testing hook breathing removing nose-clip and usual breathing (UB) in people with Exercise Training and Apnea, run by Centro Universitario La Salle at 1 site in Spain.
Trial summary
The aim of this randomized controlled trial study was to assess the effects of an 4-week exercise program on the recovery capacity after a voluntary maximal apnea. Participants will be randomly allocated to perform an experimental breathing protocol (NR-HB), or an usual training using their usual breathing (UB)… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Training, Apnea, Breathholding
- What is being tested?
- hook breathing removing nose-clip and usual breathing (UB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2020to 14 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Absence of pain or illness
- No changes in cognitive ability
- Over 18 years old.
- Member of the Spanish Federation of Underwater Activities.
- Positive medical examination that allows the diver to practice voluntary apnea.
Who cannot join
- People with systemic diseases, tumors, infections, pacemakers, history of epilepsy, hydrophobia, pregnancy women, pharmacological treatment.
- To be participating in other physical activities during the experimental research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breathing Protocol on Oxygen Saturation Recovery After a Dynamic Apnoea in Breath-hold Divers: a Single-blind, Randomized Clinical Trial
The aim of this randomized controlled trial study was to assess the effects of an 4-week exercise program on the recovery capacity after a voluntary maximal apnea. Participants will be randomly allocated to perform an experimental breathing protocol (NR-HB), or an usual training using their usual breathing (UB) protocol.
Read the detailed description
It is a multi-center study. 2 different Spanish Freedivers Centres are included in the study (Madrid and Zaragoza).
Divers were randomly assigned to receive an experimental training (NR-HB) or to be included in the Control Group (UB).
The trial included two study visits. Each exercise training program will be applied sessions per week during 4 weeks. Participants received baseline assessments at the beginning of any intervention, and post-intervention assessments at the end of the fourth week.
- Conditions
- Exercise Training, Apnea, Breathholding, Breathing Exercises
- Being tested
- hook breathing removing nose-clip, usual breathing (UB)
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hook breathing removing nose-clipOther
Participants will perform 3 days per week of usual training, involving intense exercise 8 submaximes-dynamic apnoeas with 3-minute recovery between each one per session, and continuous training of free style swimming at moderate effort over 30 minutes, including warm-up, recovery between intervals and cool down.
The experimental breathing protocol consisted on to remove nose-clip previous to surface and then perform hook breathing during 20 seconds.
usual breathing (UB)Other
Participants will perform 3 days per week of usual training, involving intense exercise 8 submaximes-dynamic apnoeas with 3-minute recovery between each one per session, and continuous training of free style swimming at moderate effort over 30 minutes, including warm-up, recovery between intervals and cool down.
| Study group | Role | What they receive |
|---|---|---|
| hook breathing removing nose-clip | Active comparator | It will apply a usual training program for 4 weeks, 4hours and 30 min per week distributed equally over 3 days in the week. In each session, it was performed 8 submaximes-dynamic apnoeas with 3-minute recovery between each one. Then was performed a maximal-dynamic apnoea. To finish the session, was performed a continuous training of free style swimming at moderate effort over 30 minutes.
During that training, only this group will perform an experimental breathing protocol consisted of removing nose-clip previous to surface and then perform hook breathing during 20 seconds. This protocol was applied at the end of each of the 8 submaximes-dynamic apnoeas and after the maximal-dynamic apnoea Receives: Other: hook breathing removing nose-clip |
| usual breathing (UB) | Active comparator | It will apply a usual training program for 4 weeks, 4hours and 30 min per week distributed equally over 3 days in the week. In each session, it was performed 8 submaximes-dynamic apnoeas with 3-minute recovery between each one. Then was performed a maximal-dynamic apnoea. To finish the session, was performed a continuous training of free style swimming at moderate effort over 30 minutes. Receives: Other: usual breathing (UB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Saturation change
Oxygen Saturation recovery will be record by the experimenters every 5 seconds by a handheld pulse-oximeter during the 1 min recovery time after a maximal dynamic apnea. The outcome was the length of the time to return to 95% SpO2 during the 1 min recovery time after maximal dynamic apnoea
Measured: Before and after training intervention (after 4 weeks)
Secondary outcomes (2)
Heart Rate recovery
Heart Rate will be record by the experimenters every 5 seconds by a handheld pulse-oximeter during the 1 min recovery time after a maximal dynamic apnea. The outcome was the length of the time to stabilize heart rate during these 1 minute.
Measured: before and after training intervention (after 4 weeks)
Lung function (forced spirometry)
The Spirometry will be perform according to American Thoracic Society criteria and was measured in litres. The maneuver will be perform 3 times and recording the best one.
Measured: before and after training intervention (after 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion14 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel-group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitario La Salle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fran de Asís Fernández, Centro Universitario La Salle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366414
- Sponsor's protocol ID
- CSEULS-PI-215/2018
- Status last verified
- Apr 2020
- First submitted
- 24 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Andersson JP, Liner MH, Runow E, Schagatay EK. Diving response and arterial oxygen saturation during apnea and exercise in breath-hold divers. J Appl Physiol (1985). 2002 Sep;93(3):882-6. doi: 10.1152/japplphysiol.00863.2001.
PubMed 12183481
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing Protocol on Oxygen Saturation Recovery After a Dynamic Apnoea in Breath-hold Divers: a Single-blind, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04366414
- Acronym / sponsor ID
- CSEULS-PI-215/2018
- Conditions
- Exercise Training, Apnea, Breathholding, Breathing Exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Centro Universitario La SalleUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 14 Dec 2020 (estimated)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized controlled trial study was to assess the effects of an 4-week exercise program on the recovery capacity after a voluntary maximal apnea. Participants will be randomly allocated to perform an experimental breathing protocol (NR-HB), or an usual training using their usual breathing (UB) protocol.
Detailed description
It is a multi-center study. 2 different Spanish Freedivers Centres are included in the study (Madrid and Zaragoza).
Divers were randomly assigned to receive an experimental training (NR-HB) or to be included in the Control Group (UB).
The trial included two study visits. Each exercise training program will be applied sessions per week during 4 weeks. Participants received baseline assessments at the beginning of any intervention, and post-intervention assessments at the end of the fourth week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- parallel-group
| Arm | Type | Receives |
|---|---|---|
| hook breathing removing nose-clip | Active comparator | Other: hook breathing removing nose-clipIt will apply a usual training program for 4 weeks, 4hours and 30 min per week distributed equally over 3 days in the week. In each session, it was performed 8 submaximes-dynamic apnoeas with 3-minute recovery between each one. Then was performed a maximal-dynamic apnoea. To finish the session, was performed a continuous training of free style swimming at moderate effort over 30 minutes. During that training, only this group will perform an experimental breathing protocol consisted of removing nose-clip previous to surface and then perform hook breathing during 20 seconds. This protocol was applied at the end of each of the 8 submaximes-dynamic apnoeas and after the maximal-dynamic apnoea |
| usual breathing (UB) | Active comparator | Other: usual breathing (UB)It will apply a usual training program for 4 weeks, 4hours and 30 min per week distributed equally over 3 days in the week. In each session, it was performed 8 submaximes-dynamic apnoeas with 3-minute recovery between each one. Then was performed a maximal-dynamic apnoea. To finish the session, was performed a continuous training of free style swimming at moderate effort over 30 minutes. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Absence of pain or illness
- No changes in cognitive ability
- Over 18 years old.
- Member of the Spanish Federation of Underwater Activities.
- Positive medical examination that allows the diver to practice voluntary apnea.
Key exclusion criteria (2 listed)
- People with systemic diseases, tumors, infections, pacemakers, history of epilepsy, hydrophobia, pregnancy women, pharmacological treatment.
- To be participating in other physical activities during the experimental research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hook breathing removing nose-clipParticipants will perform 3 days per week of usual training, involving intense exercise 8 submaximes-dynamic apnoeas with 3-minute recovery between each one per session, and continuous training of free style swimming at moderate effort over 30 minutes, including warm-up, recovery between intervals and cool down. The experimental breathing protocol consisted on to remove nose-clip previous to surface and then perform hook breathing during 20 seconds. | Other | hook breathing removing nose-clip |
| usual breathing (UB)Participants will perform 3 days per week of usual training, involving intense exercise 8 submaximes-dynamic apnoeas with 3-minute recovery between each one per session, and continuous training of free style swimming at moderate effort over 30 minutes, including warm-up, recovery between intervals and cool down. | Other | usual breathing (UB) |
Primary outcome
Oxygen Saturation change
Time frame: Before and after training intervention (after 4 weeks)
Oxygen Saturation recovery will be record by the experimenters every 5 seconds by a handheld pulse-oximeter during the 1 min recovery time after a maximal dynamic apnea. The outcome was the length of the time to return to 95% SpO2 during the 1 min recovery time after maximal dynamic apnoea
2 secondary outcomes
Heart Rate recovery
Time frame: before and after training intervention (after 4 weeks)
Lung function (forced spirometry)
Time frame: before and after training intervention (after 4 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Background: PubMed 12183481Andersson JP, Liner MH, Runow E, Schagatay EK. Diving response and arterial oxygen saturation during apnea and exercise in breath-hold divers. J Appl Physiol (1985). 2002 Sep;93(3):882-6. doi: 10.1152/japplphysiol.00863.2001.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hook breathing removing nose-clip and usual breathing (UB) in people with Exercise Training and Apnea, run by Centro Universitario La Salle at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francisco de Asís Fernández, PhD ((+34) 91 7401 980, frandeasis@lasallecampus.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Saturation change (time frame: Before and after training intervention (after 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04366414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.