NCT04084535

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

September 16, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2019

Completed
Last Updated

December 6, 2019

Status Verified

December 1, 2019

Enrollment Period

Same day

First QC Date

September 6, 2019

Last Update Submit

December 4, 2019

Conditions

Exercise TrainingRespiratory Muscle TrainingHigh-Intensity Interval TrainingApnea

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Lung function (forced spirometry)

    Before and after training intervention (after 4 weeks)

  • Maximum Respiratory Pressures

    Before and after training intervention (after 4 weeks)

  • Lactic acid recovery

    Before and after training intervention (after 4 weeks)

  • Heart Rate recovery

    Before and after training intervention (after 4 weeks)

Study Arms (2)

High intensity interval training

ACTIVE COMPARATOR

It will apply a HIIT program for 4 weeks, with 3 sessions per week of 30 min per session, including warm-up, recovery between intervals and return to calm.

Other: High intensity interval training

Inspiratory muscle training

ACTIVE COMPARATOR

It will apply an inspiratory muscle training for 4 weeks, with 3 sessions per week of 30 min per session, including warm-up, recovery between intervals and return to calm.

Other: Inspiratory muscle training

Interventions

High intensity interval trainingOTHER

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.

High intensity interval training
Inspiratory muscle trainingOTHER

Participants will perform 3 inspiratory resistance training sessions per week, involving 30 min per session, including warm-up, recovery between intervals

Inspiratory muscle training

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

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Intervention Model: Crossover Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 10, 2019

Study Start

September 16, 2019

Primary Completion

September 16, 2019

Study Completion

December 2, 2019

Last Updated

December 6, 2019

Record last verified: 2019-12

Locations

ES(1)