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Effects of High Intensity Interval Training (HIIT) vs. Inspiratory Muscle Training on the Recovery After a Maximal Apnea. ((HIIT))

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ClinicalTrials.gov Identifier: NCT04084535
Recruitment Status : Not yet recruiting
First Posted : September 10, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Fran de Asís Fernández, Centro Universitario La Salle

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.

Condition or disease Intervention/treatment Phase
Exercise Training Respiratory Muscle Training High-Intensity Interval Training Apnea Other: High intensity interval training Other: Inspiratory muscle training Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Inspiratory Muscle Training vs. High Intensity Interval Training Program on the Recovery Capacity After a Maximal Dynamic Apnea in Breath-hold Divers. A Randomized Crossover Trial
Estimated Study Start Date : September 16, 2019
Estimated Primary Completion Date : September 16, 2019
Estimated Study Completion Date : December 2, 2019

Arm Intervention/treatment
Active Comparator: High intensity interval training
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
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.

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




Primary Outcome Measures :
  1. Oxygen Saturation recovery [ Time Frame: Before and after training intervention (after 4 weeks) ]
    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.


Secondary Outcome Measures :
  1. Lung function (forced spirometry) [ Time Frame: Before and after training intervention (after 4 weeks) ]
    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.

  2. Maximum Respiratory Pressures [ Time Frame: Before and after training intervention (after 4 weeks) ]
    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.

  3. Lactic acid recovery [ Time Frame: Before and after training intervention (after 4 weeks) ]
    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.

  4. Heart Rate recovery [ Time Frame: Before and after training intervention (after 4 weeks) ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084535


Contacts
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Contact: Francisco de Asís Fernández, PhD (+34) 91 7401 980 ext 508 frandeasis@lasallecampus.es

Sponsors and Collaborators
Centro Universitario La Salle

Publications:
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Responsible Party: Fran de Asís Fernández, Principal Investigator, Centro Universitario La Salle
ClinicalTrials.gov Identifier: NCT04084535     History of Changes
Other Study ID Numbers: CSEULS - PI - 215/2018
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms