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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04366414
Other study ID # CSEULS-PI-215/2018
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date December 14, 2020

Study information

Verified date April 2020
Source Centro Universitario La Salle
Contact Francisco de Asís Fernández, PhD
Phone (+34) 91 7401 980
Email frandeasis@lasallecampus.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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) protocol.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 46
Est. completion date December 14, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design


Intervention

Other:
hook breathing removing nose-clip
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)
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.

Locations

Country Name City State
Spain Madrid FREEDIVERS association Madrid

Sponsors (1)

Lead Sponsor Collaborator
Centro Universitario La Salle

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Andersson JP, Linér MH, Rünow 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Before and after training intervention (after 4 weeks)
Secondary 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. before and after training intervention (after 4 weeks)
Secondary 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. before and after training intervention (after 4 weeks)
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