Breathing Protocol in Breath-hold Divers

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.

Study Overview

• Status: Unknown
• Conditions: Apnea; Exercise Training; Breathing Exercises; Breathholding
• Intervention / Treatment: Other: hook breathing removing nose-clip; Other: usual breathing (UB)

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 Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Madrid FREEDIVERS association

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: hook breathing removing nose-clip; 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	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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Centro Universitario La Salle

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): December 14, 2020

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: CSEULS-PI-215/2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No