Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-31 @ 6:36 PM
Study NCT ID:
NCT04084535
Status:
COMPLETED
Last Update Posted:
2019-12-06
First Post:
2019-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of High Intensity Interval Training (HIIT) vs. Inspiratory Muscle Training on the Recovery After a Maximal Apnea.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001049', 'term': 'Apnea'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Intervention Model: Crossover Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-04', 'studyFirstSubmitDate': '2019-09-06', 'studyFirstSubmitQcDate': '2019-09-09', 'lastUpdatePostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen Saturation recovery', 'timeFrame': 'Before and after training intervention (after 4 weeks)', '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.'}], 'secondaryOutcomes': [{'measure': 'Lung function (forced spirometry)', 'timeFrame': 'Before and after training intervention (after 4 weeks)', '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.'}, {'measure': 'Maximum Respiratory Pressures', 'timeFrame': 'Before and after training intervention (after 4 weeks)', '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.'}, {'measure': 'Lactic acid recovery', 'timeFrame': 'Before and after training intervention (after 4 weeks)', '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."}, {'measure': 'Heart Rate recovery', 'timeFrame': 'Before and after training intervention (after 4 weeks)', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exercise Training', 'Respiratory Muscle Training', 'High-Intensity Interval Training', 'Apnea']}, 'referencesModule': {'references': [{'pmid': '12183481', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'It is a multi-center study. 3 different Spanish Freedivers Centres are included in the study (Madrid, Zaragoza, and Barcelona).\n\nFor 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Absence of pain or illness\n* No changes in cognitive ability\n* Over 18 years old.\n* Member of the Spanish Federation of Underwater Activities.\n* Positive medical examination that allows the diver to practice voluntary apnea.\n\nExclusion Criteria:\n\n* People with systemic diseases, tumors, infections, pacemakers, history of epilepsy, hydrophobia, pregnancy women, pharmacological treatment.\n* To be participating in other physical activities during the experimental research'}, 'identificationModule': {'nctId': 'NCT04084535', 'acronym': '(HIIT)', 'briefTitle': 'Effects of High Intensity Interval Training (HIIT) vs. Inspiratory Muscle Training on the Recovery After a Maximal Apnea.', 'organization': {'class': 'OTHER', 'fullName': 'Centro Universitario La Salle'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CSEULS - PI - 215/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High intensity interval training', '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.', 'interventionNames': ['Other: High intensity interval training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Inspiratory muscle training', '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.', 'interventionNames': ['Other: Inspiratory muscle training']}], 'interventions': [{'name': 'High intensity interval training', 'type': 'OTHER', '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.', 'armGroupLabels': ['High intensity interval training']}, {'name': 'Inspiratory muscle training', 'type': 'OTHER', 'description': 'Participants will perform 3 inspiratory resistance training sessions per week, involving 30 min per session, including warm-up, recovery between intervals', 'armGroupLabels': ['Inspiratory muscle training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'country': 'Spain', 'facility': 'Madrid FREEDIVERS association', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Universitario La Salle', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fran de Asís Fernández', 'investigatorAffiliation': 'Centro Universitario La Salle'}}}}