Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-19 @ 1:26 PM
Study NCT ID:
NCT01874132
Status:
COMPLETED
Last Update Posted:
2017-05-08
First Post:
2013-06-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Long-term Effects of Exercise on Heath Indicators in Older People
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nelsons@utad.pt', 'phone': '259350756', 'title': 'Professor Nelson Sousa', 'phoneExt': '+351', 'organization': 'University of Trás-os-Montes e Alto Douro'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Aerobic Exercise Training', 'description': 'Dose response\n\nExercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Aerobic and Resistance Exercise Training', 'description': 'Dose response\n\nExercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Control', 'description': 'Non-exercising control group', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Postural orthostatic hypotension during the study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall during the study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cardiovascular Disease Risk Factors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aerobic Exercise Training', 'description': 'Dose response\n\nExercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.'}, {'id': 'OG001', 'title': 'Aerobic and Resistance Exercise Training', 'description': 'Dose response\n\nExercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.'}, {'id': 'OG002', 'title': 'Control', 'description': 'Non-exercising control group'}], 'classes': [{'title': '0 risk-factors', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': '1 risk-factor', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': '2 risk-factors', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one year', 'description': 'Descriptive frequency of the number of cardiovascular risk factors aggregated in each participant. The risk factors considered were: (i) hypertension; (ii) obesity; and (iii) dyslipidemia.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 48 participants completed the body composition, blood pressure and hematology assessments, and were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Risk of Falls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aerobic Exercise Training', 'description': 'Dose response\n\nExercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.'}, {'id': 'OG001', 'title': 'Aerobic and Resistance Exercise Training', 'description': 'Dose response\n\nExercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.'}, {'id': 'OG002', 'title': 'Control', 'description': 'Non-exercising control group'}], 'classes': [{'title': 'High risk of fall (TUG≥12 seconds)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Low risk of fall', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One year', 'description': 'Descriptive frequency of the number of participants who took ≥12 seconds to complete the Timed Get-up and Go test, and those who took less than 12 seconds (low risk of falling).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life', 'timeFrame': 'One year', 'description': 'Measured by the Satisfaction With Life Scale.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aerobic Exercise Training', 'description': 'Dose response\n\nExercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.'}, {'id': 'FG001', 'title': 'Aerobic and Resistance Exercise Training', 'description': 'Dose response\n\nExercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.'}, {'id': 'FG002', 'title': 'Control', 'description': 'Non-exercising control group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Aerobic Exercise Training', 'description': 'Dose response\n\nExercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.'}, {'id': 'BG001', 'title': 'Aerobic and Resistance Exercise Training', 'description': 'Dose response\n\nExercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.'}, {'id': 'BG002', 'title': 'Control', 'description': 'Non-exercising control group'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '71.3', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '67.2', 'spread': '5.5', 'groupId': 'BG002'}, {'value': '69.5', 'spread': '4.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Portugal', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-24', 'studyFirstSubmitDate': '2013-06-06', 'resultsFirstSubmitDate': '2016-10-18', 'studyFirstSubmitQcDate': '2013-06-06', 'lastUpdatePostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-18', 'studyFirstPostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'One year', 'description': 'Measured by the Satisfaction With Life Scale.'}], 'primaryOutcomes': [{'measure': 'Cardiovascular Disease Risk Factors', 'timeFrame': 'one year', 'description': 'Descriptive frequency of the number of cardiovascular risk factors aggregated in each participant. The risk factors considered were: (i) hypertension; (ii) obesity; and (iii) dyslipidemia.'}], 'secondaryOutcomes': [{'measure': 'Risk of Falls', 'timeFrame': 'One year', 'description': 'Descriptive frequency of the number of participants who took ≥12 seconds to complete the Timed Get-up and Go test, and those who took less than 12 seconds (low risk of falling).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Exercise', 'Blood pressure', 'Lipids', 'Body composition', 'Fitness', 'Bone density', 'Quality of life'], 'conditions': ['Hypertension With Complications and Secondary Hypertension', 'Overweight and Obesity', 'Lipid Metabolism Disorders', 'Sarcopenia', 'Osteoporosis', 'Personal Satisfaction']}, 'referencesModule': {'references': [{'pmid': '24628645', 'type': 'BACKGROUND', 'citation': 'Sousa N, Mendes R, Oliveira J. Response to Drs. Safer and Safer. J Am Geriatr Soc. 2014 Mar;62(3):590-1. doi: 10.1111/jgs.12712. No abstract available.'}, {'pmid': '23441809', 'type': 'RESULT', 'citation': 'Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. Long-term effects of aerobic training versus combined aerobic and resistance training in modifying cardiovascular disease risk factors in healthy elderly men. Geriatr Gerontol Int. 2013 Oct;13(4):928-35. doi: 10.1111/ggi.12033. Epub 2013 Feb 26.'}, {'pmid': '23628502', 'type': 'RESULT', 'citation': 'Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. A randomized 9-month study of blood pressure and body fat responses to aerobic training versus combined aerobic and resistance training in older men. Exp Gerontol. 2013 Aug;48(8):727-33. doi: 10.1016/j.exger.2013.04.008. Epub 2013 Apr 26.'}, {'pmid': '23937497', 'type': 'RESULT', 'citation': 'Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. Is once-weekly resistance training enough to prevent sarcopenia? J Am Geriatr Soc. 2013 Aug;61(8):1423-4. doi: 10.1111/jgs.12387. No abstract available.'}, {'pmid': '24779956', 'type': 'RESULT', 'citation': 'Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. Effectiveness of combined exercise training to improve functional fitness in older adults: A randomized controlled trial. Geriatr Gerontol Int. 2014 Oct;14(4):892-8. doi: 10.1111/ggi.12188. Epub 2014 Apr 30.'}, {'pmid': '25009971', 'type': 'RESULT', 'citation': 'Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. A randomized study on lipids response to different exercise programs in overweight older men. Int J Sports Med. 2014 Dec;35(13):1106-11. doi: 10.1055/s-0034-1374639. Epub 2014 Jul 10.'}, {'pmid': '27353246', 'type': 'RESULT', 'citation': 'Sousa N, Mendes R, Silva A, Oliveira J. Combined exercise is more effective than aerobic exercise in the improvement of fall risk factors: a randomized controlled trial in community-dwelling older men. Clin Rehabil. 2017 Apr;31(4):478-486. doi: 10.1177/0269215516655857. Epub 2016 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'Cardiovascular diseases (CVD) represent the most frequent cause of death among the elderly population. Hypertension, unfavorable lipid profile, obesity and physical inactivity are among the main risk factors for CVD. In contrast, mortality from CVD is inversely related to levels of physical activity, and is lower in individuals who exercise and have higher functional fitness levels. Thus, the Centers for Disease Control and Prevention, the American College of Sports Medicine, and the American Heart Association have recommended 20-30 min of moderate-to-vigorous aerobic training for the elderly, preferably every day or at least 3 days a week in the case of vigorous exercise.The same organizations also suggest the inclusion of resistance training in order to improve functional fitness. Therefore, the purpose of this study was to compare different exercise modalities in long-term changes of CVD risk factors and physical fitness among older adults.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older adults living independently;\n* medical approval.\n\nExclusion Criteria:\n\n* Non-smokers;\n* Non-morbidly obese;\n* No history of severe hypertension;\n* No history of falls;\n* No orthopaedic, neurological, pulmonary, or cardiac problems.'}, 'identificationModule': {'nctId': 'NCT01874132', 'briefTitle': 'Study of the Long-term Effects of Exercise on Heath Indicators in Older People', 'organization': {'class': 'OTHER', 'fullName': 'University of Trás-os-Montes and Alto Douro'}, 'officialTitle': 'A Randomised Longitudinal Study of Exercise Prescription for Older Adults: Mode and Intensity to Induce the Highest Cardiovascular Health-related Benefits', 'orgStudyIdInfo': {'id': 'CVD-2009-EX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic exercise training', 'description': 'Dose response', 'interventionNames': ['Behavioral: Exercise training']}, {'type': 'EXPERIMENTAL', 'label': 'Aerobic and resistance exercise training', 'description': 'Dose response', 'interventionNames': ['Behavioral: Exercise training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Non-exercising control group'}], 'interventions': [{'name': 'Exercise training', 'type': 'BEHAVIORAL', 'otherNames': ['Aerobic training', 'resistance training', 'Combined training', 'multicomponent training'], 'description': 'Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.', 'armGroupLabels': ['Aerobic and resistance exercise training', 'Aerobic exercise training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4470-384', 'city': 'Maia', 'country': 'Portugal', 'facility': 'Maia City Council facilities', 'geoPoint': {'lat': 41.23574, 'lon': -8.6199}}], 'overallOfficials': [{'name': 'Nelson Sousa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Center in Sport Sciences, Health Sciences and Human Development; University of Trás-os-Montes e Alto Douro'}, {'name': 'José Oliveira, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Research Center in Physical Activity, Health and Leisure; Sport Faculty, University of Porto'}, {'name': 'Romeu Mendes, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Trás-os-Montes and Alto Douro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Trás-os-Montes and Alto Douro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nelson Joaquim Fortuna de Sousa', 'investigatorAffiliation': 'University of Trás-os-Montes and Alto Douro'}}}}