Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-02 @ 4:43 AM
Study NCT ID:
NCT02642705
Status:
UNKNOWN
Last Update Posted:
2020-03-18
First Post:
2015-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Intensity Interval Training and Hypoxic Conditioning in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-17', 'studyFirstSubmitDate': '2015-12-24', 'studyFirstSubmitQcDate': '2015-12-24', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal exercise capacity', 'timeFrame': '8 weeks', 'description': 'Maximal oxygen consumption during an incremental exercise test'}], 'secondaryOutcomes': [{'measure': 'Metabolic status', 'timeFrame': '8 weeks', 'description': 'Blood lipids, glycemia, HOMA index, oxydative stress and inflammatory status'}, {'measure': 'Body composition', 'timeFrame': '8 weeks', 'description': 'MRI fat free mass and adipose tissue measurements'}, {'measure': 'Blood pressure', 'timeFrame': '8 weeks', 'description': '24 h ambulatory blood pressure mesurement'}, {'measure': 'Vascular function', 'timeFrame': '8 weeks', 'description': 'Post-ischemic hyperemia (Endo-Pat) and pulse wave velocity'}, {'measure': 'Physical activity', 'timeFrame': '8 weeks', 'description': 'Spontaneous physical activity measured by accelerometry'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '26157787', 'type': 'BACKGROUND', 'citation': 'Verges S, Chacaroun S, Godin-Ribuot D, Baillieul S. Hypoxic Conditioning as a New Therapeutic Modality. Front Pediatr. 2015 Jun 22;3:58. doi: 10.3389/fped.2015.00058. eCollection 2015.'}, {'pmid': '24144531', 'type': 'BACKGROUND', 'citation': 'Weston KS, Wisloff U, Coombes JS. High-intensity interval training in patients with lifestyle-induced cardiometabolic disease: a systematic review and meta-analysis. Br J Sports Med. 2014 Aug;48(16):1227-34. doi: 10.1136/bjsports-2013-092576. Epub 2013 Oct 21.'}]}, 'descriptionModule': {'briefSummary': 'The present study aims at evaluating the effect of two innovative treatment strategies in obese patients: high intensity interval training and hypoxic conditioning. Obese patients will be randomized in groups performing high intensity interval training, constant load training, hypoxic conditioning or placebo normoxic conditioning for 8 weeks. The effects of the interventions will be measured regarding exercise tolerance, blood pressure, body composition, metabolic status.', 'detailedDescription': '120 obese patients will be randomized to 6 intervention groups. Each group will follow an 8-week intervention (3 session per week) with either high intensity interval training in normoxia or hypoxia, constant load exercise training in normoxia or hypoxia, hypoxic or normoxic (placebo) conditioning at rest. Exercise capacity, metabolic status, blood pressure, vascular function and physical activity will be assessed before and after the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 27 and 35 kg/m²\n* Physical activity \\<2 hours/week\n* No chronic disease or treatment able to interfere with inflammation and metabolic perturbatiosn associated with obesity\n\nExclusion Criteria:\n\n* Diabetes mellitus treated with insulin\n* Auto-immune or inflammatory diseases requiring long term therapy\n* Unstable dysthyroidism\n* Bariatric surgery within the past 18 months\n* Tumoral, inflammatory, infectious, cardiac, respiratory, kidney, digestive disease\n* Untreated sleep apnea'}, 'identificationModule': {'nctId': 'NCT02642705', 'acronym': 'HYPINT', 'briefTitle': 'High Intensity Interval Training and Hypoxic Conditioning in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'New Treatment Modalities in Obese Patients: High Intensity Interval Training and Hypoxic Conditioning', 'orgStudyIdInfo': {'id': '2014-A01482-45'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High intensity interval training N', 'description': 'High intensity interval training N: The intervention consists in 8-week exercise training, 3 times a week for one hour, according to a high intensity interval training protocol (1 min ON at 100% maximal power output, 1 min OFF), breathing ambient air (normoxia)', 'interventionNames': ['Other: High intensity interval training N']}, {'type': 'EXPERIMENTAL', 'label': 'High intensity interval training H', 'description': 'High intensity interval training H: The intervention consists in 8-week exercise training, 3 times a week for one hour, according to a high intensity interval training protocol (1 min ON at 100% maximal power output, 1 min OFF), breathing hypoxic air (about 3 500 m of altitude)', 'interventionNames': ['Other: High intensity interval training H']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Constant load exercise training N', 'description': 'Constant load exercise training N: The intervention consists in 8-week exercise training, 3 times a week for one hour, according to a constant load training protocol (50% maximal power output), breathing ambient air (normoxia)', 'interventionNames': ['Other: Constant load exercise training N']}, {'type': 'EXPERIMENTAL', 'label': 'Constant load exercise training H', 'description': 'Constant load exercise training H: The intervention consists in 8-week exercise training, 3 times a week for one hour, according to a constant load training protocol (50% maximal power output), breathing hypoxic air (about 3 500 m of altitude)', 'interventionNames': ['Other: Constant load exercise training H']}, {'type': 'EXPERIMENTAL', 'label': 'Hypoxic conditioning at rest', 'description': 'Hypoxic conditioning at rest : The intervention consists in 8-week conditioning period, 3 times a week, hypoxic breathing for one hour (about 4500 m of altitude) while seating quietly', 'interventionNames': ['Other: Hypoxic conditioning at rest']}, {'type': 'SHAM_COMPARATOR', 'label': 'Normoxic conditioning at rest', 'description': 'Normoxic conditioning at rest : The intervention consists in 8-week conditioning period, 3 times a week, normoxic breathing for one hour (ambient air) while seating quietly', 'interventionNames': ['Other: Normoxic conditioning at rest']}], 'interventions': [{'name': 'High intensity interval training N', 'type': 'OTHER', 'description': 'Exercise training and ambient air breathing', 'armGroupLabels': ['High intensity interval training N']}, {'name': 'High intensity interval training H', 'type': 'OTHER', 'description': 'Exercise training and hypoxic breathing', 'armGroupLabels': ['High intensity interval training H']}, {'name': 'Constant load exercise training N', 'type': 'OTHER', 'description': 'Exercise training and ambient air breathing', 'armGroupLabels': ['Constant load exercise training N']}, {'name': 'Constant load exercise training H', 'type': 'OTHER', 'description': 'Exercise training and hypoxic breathing', 'armGroupLabels': ['Constant load exercise training H']}, {'name': 'Hypoxic conditioning at rest', 'type': 'OTHER', 'description': 'Hypoxic breathing at rest', 'armGroupLabels': ['Hypoxic conditioning at rest']}, {'name': 'Normoxic conditioning at rest', 'type': 'OTHER', 'description': 'Normoxic breathing at rest (placebo)', 'armGroupLabels': ['Normoxic conditioning at rest']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Samuel Verges, PhD', 'role': 'CONTACT', 'email': 'sverges@chu-grenoble.fr', 'phone': '0476766860'}], 'facility': 'Grenoble University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'centralContacts': [{'name': 'Samuel Verges, PhD', 'role': 'CONTACT', 'email': 'sverges@chu-grenoble.fr', 'phone': '0476766860'}, {'name': 'Patrice Flore, PhD', 'role': 'CONTACT', 'email': 'pflore@chu-grenoble.fr', 'phone': '0476768921'}], 'overallOfficials': [{'name': 'Bernard Wuyam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}