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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04084535
Other study ID # CSEULS - PI - 215/2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 16, 2019
Est. completion date December 2, 2019

Study information

Verified date December 2019
Source Centro Universitario La Salle
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this randomized cross-over controlled 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 receive either a high intensity interval training (HIIT), or an inspiratory muscle training (IMT) using an inspiratory resistance device.


Description:

It is a multi-center study. 3 different Spanish Freedivers Centres are included in the study (Madrid, Zaragoza, and Barcelona).

For each participant, exercise program started with one or the other program. Hence, both interventions were applied once with the participant randomly allocated to receive the same intervention. The trial included four study visits. Each exercise training program will be applied sessions per week during 4 weeks. Participants received baseline assessments at the beginning of nay intervention, and post-intervention assessments at the end of the fourth week. The wash-out period will be two weeks. After these two weeks participants switched intervention.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 2, 2019
Est. primary completion date September 16, 2019
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:
High intensity interval training
Participants will perform 3 HIIT sessions per week, involving 10 min of intense exercise within a time commitment of 30 min per session, including warm-up, recovery between intervals and cool down.
Inspiratory muscle training
Participants will perform 3 inspiratory resistance training sessions per week, involving 30 min per session, including warm-up, recovery between intervals

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 recovery 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 represents the time it takes to get a 95% of saturation 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)
Secondary Maximum Respiratory Pressures The maximum respiratory pressures (MIP and MEP) will be measure with a device. This device applies an inspiratory/expiratory load which provides a resistance. The maneuver will be perform in a sitting position. Measuring a minimum of 3 times will be perform, recording the highest value. Before and after training intervention (after 4 weeks)
Secondary Lactic acid recovery The level of lactic acid in the blood will be measure by a device that used a blood lactic acid measurement that you've gotten by the finger-stick method. It will be record by the experimenters 3 times: immediately after the maximal dynamic apnea, after 3 min and after 10 min of the maximal dynamic apnea. 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 represents how long does it take before the participant periodic Heart Rate is stabilized during these 1 minute. Before and after training intervention (after 4 weeks)
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