Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT04425005
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2020-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Home-based Exercise Training During Covid-19 Pandemic in Post-bariatric
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-18', 'studyFirstSubmitDate': '2020-06-08', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline on waist circumference at 3 months of follow-up.', 'timeFrame': 'Baseline and 3 months', 'description': 'Waist circumference will be measured using a steel measuring tape to the nearest 0.1cm at the high point of the iliac crest at minimal respiration.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline on cardiometabolic risk factor at 3 months of follow-up.', 'timeFrame': 'Baseline and 3 months', 'description': 'Cardiometabolic risk will be calculated using mean blood pressure, fasting triglycerides, HDL, waist circumference and fasting glucose. These outocomes will be presented separately as well.'}, {'measure': 'Change from baseline on cardiopulmonary fitness at 3 months of follow-up.', 'timeFrame': 'Baseline and 3 months', 'description': 'Cardiopulmonary fitness will be assessed by a validated two-minutes step test.'}, {'measure': 'Change from baseline on quality of life at 3 months of follow up.', 'timeFrame': 'Baseline and 3 months', 'description': 'Will be evaluated by the SF-36 health survey questionnaire.'}, {'measure': 'Change from baseline on Physical activity levels at 3 months of follow up.', 'timeFrame': 'Baseline and 3 months follow-up.', 'description': 'Will be evaluated by the International Physical Activity Questionnaire.'}, {'measure': 'Change from baseline on dietary intake at 3 months of follow up.', 'timeFrame': 'Baseline and 3 months', 'description': 'Will be assessed by 24 hours food intake recall.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bariatric Surgery', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the effect of a home-based exercise training during social isolation due to covid-19 pandemic in patients who undertook bariatric surgery.', 'detailedDescription': 'Eligible patients will be invited to participate in the study by phone call. The research team will visit the included patients. All patients giving the written consent will perform the following tests before being randomly allocated into exercise training or control: 1) blood pressure; 2) anthropometric measures; 3) blood sampling; 4) handgrip test; 5) sit and stand test; 6) exercise capacity; 7) nutritional recalls and 8) health-related questionnaires. Patients will be randomized in a 1:1 ratio to control group (will receive information to keep active and eating healthy) or exercise training group (will receive a telemonitored exercise program through video conference, three times a week, during 3 months). Following 3 months of intervention, the outocomes will be re-assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women submitted to bariatric surgery in the last 12 months.\n* Not engaged in regular exercise training programs.\n\nExclusion Criteria:\n\n* Patients with \\>12 months of post-operatory period.\n* Patients with diagnosed mental disorders.\n* Patients with physical limitations or not allowed by the physician to exercise.\n* Patients infected with Covid-19 at the time of data collection.'}, 'identificationModule': {'nctId': 'NCT04425005', 'briefTitle': 'Home-based Exercise Training During Covid-19 Pandemic in Post-bariatric', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effect of Home-based Exercise Training Program During the Covid-19 Pandemic in Post-bariatric Patients: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '21056813.3.0000.0068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group'}, {'type': 'EXPERIMENTAL', 'label': 'Exercise training group', 'interventionNames': ['Other: Home-based exercise']}], 'interventions': [{'name': 'Home-based exercise', 'type': 'OTHER', 'description': 'Home-based exercise training, supervised by videoconference.', 'armGroupLabels': ['Exercise training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508-030', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Univsersity of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Bruno Gualano', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HC FMUSP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bruno Gualano', 'investigatorAffiliation': 'University of Sao Paulo'}}}}