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Breathing Protocol in Breath-hold Divers

Primary Purpose

Exercise Training, Apnea, Breathholding

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
hook breathing removing nose-clip
usual breathing (UB)
Sponsored by
Centro Universitario La Salle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise Training

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Madrid FREEDIVERS association

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

hook breathing removing nose-clip

usual breathing (UB)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 24, 2020
Last Updated
April 27, 2020
Sponsor
Centro Universitario La Salle
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1. Study Identification

Unique Protocol Identification Number
NCT04366414
Brief Title
Breathing Protocol in Breath-hold Divers
Official Title
Breathing Protocol on Oxygen Saturation Recovery After a Dynamic Apnoea in Breath-hold Divers: a Single-blind, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
December 14, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitario La Salle

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Training, Apnea, Breathholding, Breathing Exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel-group
Masking
Outcomes Assessor
Masking Description
single-blind
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hook breathing removing nose-clip
Arm Type
Active Comparator
Arm Description
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
Arm Title
usual breathing (UB)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
hook breathing removing nose-clip
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
usual breathing (UB)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oxygen Saturation change
Description
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
Time Frame
Before and after training intervention (after 4 weeks)
Secondary Outcome Measure Information:
Title
Heart Rate recovery
Description
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.
Time Frame
before and after training intervention (after 4 weeks)
Title
Lung function (forced spirometry)
Description
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.
Time Frame
before and after training intervention (after 4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francisco de Asís Fernández, PhD
Phone
(+34) 91 7401 980
Email
frandeasis@lasallecampus.es
Facility Information:
Facility Name
Madrid FREEDIVERS association
City
Madrid
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco de Asís Fernández

12. IPD Sharing Statement

Citations:
PubMed Identifier
12183481
Citation
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.
Results Reference
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Breathing Protocol in Breath-hold Divers

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