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

Primary Purpose

Exercise Training, Respiratory Muscle Training, High-Intensity Interval Training

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
High intensity interval training
Inspiratory muscle training
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

High intensity interval training

Inspiratory muscle training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Maximum Respiratory Pressures
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.
Lactic acid recovery
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.
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 represents how long does it take before the participant periodic Heart Rate is stabilized during these 1 minute.

Full Information

First Posted
September 6, 2019
Last Updated
December 4, 2019
Sponsor
Centro Universitario La Salle
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1. Study Identification

Unique Protocol Identification Number
NCT04084535
Brief Title
Effects of High Intensity Interval Training (HIIT) vs. Inspiratory Muscle Training on the Recovery After a Maximal Apnea.
Acronym
(HIIT)
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
September 16, 2019 (Actual)
Study Completion Date
December 2, 2019 (Actual)

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Training, Respiratory Muscle Training, High-Intensity Interval Training, Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Intervention Model: Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High intensity interval training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Inspiratory muscle training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
High intensity interval training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training
Intervention Description
Participants will perform 3 inspiratory resistance training sessions per week, involving 30 min per session, including warm-up, recovery between intervals
Primary Outcome Measure Information:
Title
Oxygen Saturation recovery
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 represents the time it takes to get a 95% of saturation during these 1 minute.
Time Frame
Before and after training intervention (after 4 weeks)
Secondary Outcome Measure Information:
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)
Title
Maximum Respiratory Pressures
Description
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.
Time Frame
Before and after training intervention (after 4 weeks)
Title
Lactic acid recovery
Description
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.
Time Frame
Before and after training intervention (after 4 weeks)
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 represents how long does it take before the participant periodic Heart Rate is stabilized during these 1 minute.
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
Facility Information:
Facility Name
Madrid FREEDIVERS association
City
Madrid
Country
Spain

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

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