- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04084535
Effects of High Intensity Interval Training (HIIT) vs. Inspiratory Muscle Training on the Recovery After a Maximal Apnea. ((HIIT))
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Madrid, Spain
- Madrid FREEDIVERS association
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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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.
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Participants will perform 3 inspiratory resistance training sessions per week, involving 30 min per session, including warm-up, recovery between intervals
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygen Saturation recovery
Time Frame: Before and after training intervention (after 4 weeks)
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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.
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Before and after training intervention (after 4 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung function (forced spirometry)
Time Frame: Before and after training intervention (after 4 weeks)
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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.
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Before and after training intervention (after 4 weeks)
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Maximum Respiratory Pressures
Time Frame: Before and after training intervention (after 4 weeks)
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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.
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Before and after training intervention (after 4 weeks)
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Lactic acid recovery
Time Frame: Before and after training intervention (after 4 weeks)
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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.
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Before and after training intervention (after 4 weeks)
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Heart Rate recovery
Time Frame: Before and after training intervention (after 4 weeks)
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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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Before and after training intervention (after 4 weeks)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSEULS - PI - 215/2018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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