Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-03-05 @ 5:40 PM
Study NCT ID:
NCT01910935
Status:
COMPLETED
Last Update Posted:
2014-06-06
First Post:
2013-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Physical Activity Prescription Among Hypertensive Patients of Primary Health Care.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-04', 'studyFirstSubmitDate': '2013-07-05', 'studyFirstSubmitQcDate': '2013-07-26', 'lastUpdatePostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Composite measure of biochemical markers: total cholesterol, triglycerides and fasting blood glucose', 'timeFrame': '24 weeks', 'description': 'Biochemical markers (total cholesterol, triglycerides and fasting blood glucose) among intervention and control groups, at the three moments of the study: basal measurement, 24 weeks (end of the intervention) and 36 weeks. The secondary outcome measure is a composite at three moments of the study. Basal measurement, 24 weeks and 36 weeks, this last moment to assess sustainability of the intervention.'}], 'primaryOutcomes': [{'measure': 'Physical activity. Level of physical activity between intervention and control groups.', 'timeFrame': '24 weeks', 'description': 'The length of the intervention is 24 weeks, the control group will be followed for 24 weeks also. The outcome measure is a composite at three moments of the study. Basal measurement, 24 weeks and 36 weeks, this last moment to assess sustainability of the intervention.\n\nThe intervention will be effective if the difference in the percent of population (complying the minimum recommended of physical activity) among control and intervention groups is at least of 20%.'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '24 weeks', 'description': 'Blood pressure among intervention and control groups, at the three moments of the study: basal measurement, 24 weeks (end of the intervention) and 36 weeks. The outcome measure is a composite at three moments of the study. Basal measurement, 24 weeks and 36 weeks, this last moment to assess sustainability of the intervention.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Physical activity', 'Hypertension', 'Scheme reference', 'Primary care'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '25011612', 'type': 'DERIVED', 'citation': "Gallegos-Carrillo K, Garcia-Pena C, Salmeron J, Salgado-de-Snyder VN, Vazquez-Cabrer G, Lobelo F. Exercise-referral scheme to promote physical activity among hypertensive patients: design of a cluster randomized trial in the Primary Health Care Units of Mexico's Social Security System. BMC Public Health. 2014 Jul 9;14:706. doi: 10.1186/1471-2458-14-706."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of a program to increase the physical activity of hypertensive patients using medical services and sports facilities of the Mexican Social Security Institute. The primary hypothesis to be proven is: The intervention will increase the proportion of hypertensive patients complying the physical activity minimum at week to get benefits on health in 20%, compare to patients in control group.', 'detailedDescription': 'Secondary Hypothesis:\n\nThe intervention achieved a significant change in the group of hypertensive patients in the following variables:\n\n1. Decreased levels of systolic and diastolic blood pressure, biochemical markers such as total cholesterol, triglycerides and fasting blood glucose and increased HDL cholesterol.\n2. Increase muscular endurance and cardio-respiratory capacity according to the categories of risk stratification.\n3. Decreased body weight, body mass index and waist circumference.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with high blood pressure \\<5 years of evolution and / or without use of drug therapy to treat that condition;\n* with low levels of physical activity (PA) or physically inactive (less than 150 minutes of PA at week, intensity moderate to vigorous);\n* with availability to PA practice or considering begin to PA practice within the next six months (contemplation or preparation stages of the Transtheoretical Model).\n* Without cardiovascular risk (assessed previously);\n* Without physical or mobility problems that impede PA practice;\n* Willingness to participate in the study, fulfill with outlined activities to develop the proposal.\n\nExclusion Criteria:\n\n* high-risk patients according to the risk stratification of the American College of Sports Medicine;\n* fulfill the high recommendation of physical activity (more than 300 minutes per week of moderate to vigorous intensity);'}, 'identificationModule': {'nctId': 'NCT01910935', 'briefTitle': 'Effectiveness of Physical Activity Prescription Among Hypertensive Patients of Primary Health Care.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Coordinación de Investigación en Salud, Mexico'}, 'officialTitle': 'Effectiveness of Physical Activity Prescription Among Hypertensive Patients of Primary Health Care.', 'orgStudyIdInfo': {'id': '2009-785-038'}, 'secondaryIdInfos': [{'id': 'FIS/IMSS/PROT/G10/841', 'type': 'OTHER', 'domain': 'FIS/IMSS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical activity prescription', 'description': '24 weeks physical activity program. 1 hour, 3 times a week, moderate to vigorous intensity.', 'interventionNames': ['Behavioral: Physical activity prescription to develop program in group.']}, {'type': 'NO_INTERVENTION', 'label': 'No physical activity prescription', 'description': 'Provide information to patients about the benefits of physical activity and how to increase it safely.'}], 'interventions': [{'name': 'Physical activity prescription to develop program in group.', 'type': 'BEHAVIORAL', 'description': 'Overall the intervention involves a medical reference in primary care (PHC) to hypertensive patients (during routine consultation) to assist the sports facilities of the same Institute, to develop a group program of physical activity which will last 24 weeks. Led by the trained staff in physical activity to patients with chronic diseases.', 'armGroupLabels': ['Physical activity prescription']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62000', 'city': 'Cuernavaca', 'state': 'Morelos', 'country': 'Mexico', 'facility': 'Instituto Mexicano del Seguro Social. Morelos. HGR/MF. No, UMF 3, UMF 20, UMF 23', 'geoPoint': {'lat': 18.9261, 'lon': -99.23075}}], 'overallOfficials': [{'name': 'Gallegos-Carrillo Katia, D. Sc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Mexicano del Seguro Social/Unidad de Investigación Epidemiologica y en Servicios de Salud.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coordinación de Investigación en Salud, Mexico', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}