Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2026-02-26 @ 4:17 PM
Study NCT ID:
NCT03233061
Status:
COMPLETED
Last Update Posted:
2017-08-01
First Post:
2017-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Obesity Influence Women Cardiorespiratory Fitness and Daily Physical Activities? (ACTIVOB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072599', 'term': 'Cardiorespiratory Fitness'}], 'ancestors': [{'id': 'D010809', 'term': 'Physical Fitness'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D006262', 'term': 'Health'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Women OBESE group VS Women NON-OBESE group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-29', 'studyFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2017-07-27', 'lastUpdatePostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of relative peak oxygen consumption between obese and non-obese women , mesured with indirect calorimetry', 'timeFrame': '2 months', 'description': '⩒O2 peak comparison between OB vs NO women. For each household activity, the intensity expressed by the ratio ⩒O2 activity/resting ⩒O2 or the ratio ⩒O2 activity /⩒O2 peak will be compared between NO and OB'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity; cardiorespiratory fitness; oxygen uptake; household activities; physical activity; sedentary; intensity; obese women'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Many obese individuals experience difficulties in executing household activities. In this study, we investigate the cardiorespiratory fitness (CRF) of obese vs. non-obese women, and the impact of obesity on cardiorespiratory functioning during daily household activities.', 'detailedDescription': 'Methods: On 48 sedentary female subjects will be assessed by cardiorespiratory exercise testing with evaluation of peak oxygen uptake (⩒O2), heart rate (HR) and maximal cycling power output. Next, cardiorespiratory functioning will be assessed during household activities such as ironing (A1), cleaning floor (A2), walking and climbing stairs (A3).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI = weight in kilograms/(height in meters) x (height in meters)) as: healthy obese (OB group (OB); BMI between 30 to 39.9 kg.m-2; n = 20), and healthy non obese (NO group (NO); BMI between 18.5 to 24.9 kg.m-2; n = 28).\n\nExclusion Criteria:\n\n* comorbidities (other than obesity) :\n\n 1. history of systemic hypertension or antihypertensive medication, diabetes mellitus, cardiovascular or respiratory disease, systemic disease, smoking;\n 2. any drugs;\n 3. BMI \\>40 kg.m-2;\n 4. having a regular physical activity.'}, 'identificationModule': {'nctId': 'NCT03233061', 'acronym': 'ACTIVOB', 'briefTitle': 'Does Obesity Influence Women Cardiorespiratory Fitness and Daily Physical Activities? (ACTIVOB)', 'organization': {'class': 'OTHER', 'fullName': 'Laboratory of Movement, Condorcet, Tournai, Belgium'}, 'officialTitle': 'Does Obesity Influence Women Cardiorespiratory Fitness and Daily Physical Activities?', 'orgStudyIdInfo': {'id': '2017001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NO', 'description': 'NON OBESE WOMEN GROUP ( same age and same physical activities ) cardiorespiratory exercise testing with evaluation of peak oxygen uptake, heart rate and maximal cycling power output. Cardiorespiratory functioning is assessed during household activities such as ironing,cleaning floor,walking and climbing stairs.', 'interventionNames': ['Diagnostic Test: cardiorespiratory fitness and daily physical activities evaluations']}, {'type': 'EXPERIMENTAL', 'label': 'OB', 'description': 'OBESE GROUP cardiorespiratory exercise testing with evaluation of peak oxygen uptake,heart rate and maximal cycling power output.Cardiorespiratory functioning is assessed during household activities such as ironing, cleaning floor, walking and climbing stairs', 'interventionNames': ['Diagnostic Test: cardiorespiratory fitness and daily physical activities evaluations']}], 'interventions': [{'name': 'cardiorespiratory fitness and daily physical activities evaluations', 'type': 'DIAGNOSTIC_TEST', 'description': 'The cardiopulmonary exercise testing is performed on a cycle ergometer connected to cardiovascular and respiratory software. Subjects have a facemask, which collected respiratory and metabolic variables.An incremental exercise test is performed up to exhaustion. ⩒O2 is recorded and heart rate is averaged by an electrocardiogram system.\n\nCardiopulmonary exercise testing during household activities Subjects have to perform 3 everyday life household activities: ironing,cleaning floor,walking and climbing stairs.A wearable ambulatory indirect metabolic system is used with Holter mode to record cardiorespiratory measures.Subjects have to breathe through the K4b2 facemask and turbine.', 'armGroupLabels': ['NO', 'OB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500', 'city': 'Tournai', 'state': 'HAinaut', 'country': 'Belgium', 'facility': "LAboratoire de l'effort et du mouvement", 'geoPoint': {'lat': 50.60715, 'lon': 3.38932}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratory of Movement, Condorcet, Tournai, Belgium', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Laboratory Head', 'investigatorFullName': 'Grégory Cuvelier', 'investigatorAffiliation': 'Laboratory of Movement, Condorcet, Tournai, Belgium'}}}}