Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:28 PM
Study NCT ID:
NCT03872258
Status:
COMPLETED
Last Update Posted:
2022-08-31
First Post:
2019-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of an Intensive Intervention to Improve Physical Activity in Postmenopausal and Sedentary Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-30', 'studyFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2019-03-11', 'lastUpdatePostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical activity', 'timeFrame': '6 months', 'description': 'Physical activity, will be measured using an accelerometer'}, {'measure': 'Self-reported physical activity', 'timeFrame': '6 months', 'description': 'Measured by the International Physical Activity Questionary - Short Form'}, {'measure': 'Self-reported sedentary', 'timeFrame': '6 months', 'description': 'Measured by the Marshall Questionary'}], 'secondaryOutcomes': [{'measure': 'Body composition', 'timeFrame': '6 months', 'description': 'Measurement by InBody 230.'}, {'measure': 'Body mass index', 'timeFrame': '6 months', 'description': 'Measurement by InBody 230'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical activity', 'Postmenopause', 'Body composition', 'Health education', 'Information and Communication Technologies'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '33481300', 'type': 'DERIVED', 'citation': 'Alonso-Dominguez R, Sanchez-Aguadero N, Llamas-Ramos I, Lugones-Sanchez C, Gonzalez-Sanchez S, Gomez-Marcos MA, Garcia-Ortiz L; Ewomen Investigators. Effect of an intensive intervention on the increase of physical activity and the decrease of sedentary lifestyle in inactive postmenopausal. J Adv Nurs. 2021 Apr;77(4):2064-2072. doi: 10.1111/jan.14737. Epub 2021 Jan 22.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized clinical trial aimed at postmenopausal women aged 45 to 70 years old selected in urban primary care centers of two centers (Spain). Its objective is to evaluate the effects of an intensive intervention in the increase of physical activity and the decrease of sedentary lifestyle in postmenopausal and sedentary women.', 'detailedDescription': 'Objective: to evaluate the effects at 6 months of an intensive intervention in the increase of physical activity and the decrease of sedentary lifestyle in postmenopausal and sedentary women.\n\nDesign and setting: A randomized clinical trial of two parallel groups. Population: 100 postmenopausal women, 45 to 70 aged will be included, selected by consecutive sampling in two primary care centers.\n\nMeasurements and intervention: Physical activity, body composition, BMI and health-related quality of life will be evaluated. The intervention group will receive an intensive program of combined exercise for 6 months and use during this period a Smartband, in order to encourage and increase physical activity and decrease sedentary lifestyle'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women in postmenopausal period defined as 12 consecutive months of amenorrhea.\n\nExclusion Criteria:\n\n* Older than 70 years are excluded, due to difficulties in the use of Information and Communication Technologies.\n* History of cardiovascular events (acute myocardial infarction, stroke, etc).\n* Diagnosis of clinically demonstrable neurological and/or neuropsychological disease.\n* Muscular-skeletal pathology that inhibit mobility.\n* Those with any other circumstance that the investigators consider could interfere with the study procedures.'}, 'identificationModule': {'nctId': 'NCT03872258', 'briefTitle': 'Effectiveness of an Intensive Intervention to Improve Physical Activity in Postmenopausal and Sedentary Women', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Investigacion y Formacion en Ciencias de la Salud'}, 'officialTitle': 'Effectiveness of an Intensive Intervention to Improve Physical Activity in Postmenopausal and Sedentary Women', 'orgStudyIdInfo': {'id': 'GRS 1823/B/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Counseling on physical activity', 'interventionNames': ['Behavioral: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Add an intensive program of combined exercise for 6 months and use during this period a Smartband, in order to encourage and increase physical activity and decrease sedentary lifestyle', 'interventionNames': ['Behavioral: Control', 'Behavioral: Intervention group']}], 'interventions': [{'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Counseling on physical activity', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Intervention group', 'type': 'BEHAVIORAL', 'description': 'Program of combined exercise and a Smartband for 6 months.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37003', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Instituto Biosanitario de Salamanca. Research unit La Alamedilla', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}], 'overallOfficials': [{'name': 'Luis Garcia-Ortiz', 'role': 'STUDY_CHAIR', 'affiliation': 'Primary Health Care Research Unit, The A'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Investigacion y Formacion en Ciencias de la Salud', 'class': 'OTHER'}, 'collaborators': [{'name': 'Castilla-León Health Service', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}