NCT04366414

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2020

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

Same day

First QC Date

April 24, 2020

Last Update Submit

April 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Heart Rate recovery

    before and after training intervention (after 4 weeks)

  • Lung function (forced spirometry)

    before and after training intervention (after 4 weeks)

Study Arms (2)

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

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.

Other: usual breathing (UB)

Interventions

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.

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.

usual breathing (UB)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Madrid FREEDIVERS association

Madrid, Spain

Location

Related Publications (1)

  • 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.

    PMID: 12183481BACKGROUND

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Francisco de Asís Fernández, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
single-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: parallel-group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 28, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2020

Study Completion

December 14, 2020

Last Updated

April 28, 2020

Record last verified: 2020-04

Locations