Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-29 @ 12:51 PM
Study NCT ID:
NCT01614392
Status:
COMPLETED
Last Update Posted:
2018-12-10
First Post:
2009-09-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lower Extremity Muscle and Function in the Elderly: Study 2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051346', 'term': 'Mobility Limitation'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Roger.Fielding@tufts.edu', 'phone': '6175563083', 'title': 'Dr. Roger Fielding', 'organization': 'Jean Mayer USDA HNRCA, Tufts University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 months', 'eventGroups': [{'id': 'EG000', 'title': 'High Velocity Low Force Power Training', 'description': 'Lower extremity high velocity power training performed at lower external resistance (40% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).', 'otherNumAtRisk': 25, 'otherNumAffected': 1, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Velocity High Force Power Training', 'description': 'Lower extremity low velocity power training performed at high external resistance (70% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).', 'otherNumAtRisk': 27, 'otherNumAffected': 3, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'General', 'notes': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'notes': 'Hamstring and back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary', 'notes': 'Exacerbation of COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'notes': 'Non-injurious fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Leg Extensor Muscle Power', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Power Training Performed at Low External Resistance', 'description': 'High velocity low force power training performed at low external resistance (40% of the 1repetition maximum strength (RM)\\[LO\\]'}, {'id': 'OG001', 'title': 'Power Training Performed at High External Resistance', 'description': 'Low velocity high force power training performed at high external resistance (70% of the 1 repetition maximum (RM) \\[HI\\])'}], 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'spread': '13', 'groupId': 'OG000'}, {'value': '41.6', 'spread': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to Week 16', 'description': 'Leg extensor muscle power measured on pneumatic strength testing equipment at a external force consistent with 70% of the participant maximum leg extensor strength.', 'unitOfMeasure': 'Watts', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '4 participants dropped out of study before follow up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Velocity Low Force Power Training', 'description': 'Lower extremity high velocity power training performed at lower external resistance (40% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).'}, {'id': 'FG001', 'title': 'Low Velocity High Force Power Training', 'description': 'Lower extremity low velocity power training performed at high external resistance (70% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High Velocity Low Force Power Training', 'description': 'Lower extremity high velocity power training performed at lower external resistance (40% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).'}, {'id': 'BG001', 'title': 'Low Velocity High Force Power Training', 'description': 'Lower extremity low velocity power training performed at high external resistance (70% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '78.3', 'spread': '5', 'groupId': 'BG000'}, {'value': '77.6', 'spread': '4', 'groupId': 'BG001'}, {'value': '77.9', 'spread': '4.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-06', 'studyFirstSubmitDate': '2009-09-28', 'resultsFirstSubmitDate': '2017-05-26', 'studyFirstSubmitQcDate': '2012-06-05', 'lastUpdatePostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-06', 'studyFirstPostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leg Extensor Muscle Power', 'timeFrame': 'Change from baseline to Week 16', 'description': 'Leg extensor muscle power measured on pneumatic strength testing equipment at a external force consistent with 70% of the participant maximum leg extensor strength.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Resistance Exercise', 'Physical Activity', 'Mobility disability', 'Physical function', 'Muscle Strength', 'Older Adults', 'Mobility-Limited', 'Peak power and strength'], 'conditions': ['Mobility Limitation']}, 'descriptionModule': {'briefSummary': 'This research study is looking to compare the effects of two uniquely different power training interventions (high force, lower velocity versus low force, high velocity) on changes in mobility status among older individuals at risk for mobility disability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and Female 70-85 yrs\n* Community dwelling\n* Short Performance Battery Score \\>9\n* BMI range 19-32 kg/m2\n* Willingness to be randomized and come the laboratory for 20 weeks.\n\nExclusion Criteria:\n\n* Acute or Terminal Illness\n* MI in previous 6 months, symptomatic coronary artery disease or congestive heart failure.\n* Upper or Lower extremity fracture in previous 6 months\n* Uncontrolled hypertension (150/90mmHg)\n* Neuromuscular diseases and drugs that affect neuromuscular function\n* Hormone replacement therapy\n* Participation in any regular endurance or resistance training exercise during previous 3 months'}, 'identificationModule': {'nctId': 'NCT01614392', 'briefTitle': 'Lower Extremity Muscle and Function in the Elderly: Study 2', 'organization': {'class': 'OTHER', 'fullName': 'Tufts University'}, 'officialTitle': 'Lower Extremity Muscle and Function in the Elderly: Study 2', 'orgStudyIdInfo': {'id': 'AG-18844'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High velocity low force Power Training', 'description': 'Lower Extremity high velocity power training performed at lower external resistance (40% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).', 'interventionNames': ['Behavioral: High velocity low force Power Training']}, {'type': 'EXPERIMENTAL', 'label': 'Low velocity high force Power Training', 'description': 'Lower extremity low velocity power training performed at high external resistance (70% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).', 'interventionNames': ['Behavioral: Low velocity high force Power Training']}], 'interventions': [{'name': 'High velocity low force Power Training', 'type': 'BEHAVIORAL', 'description': 'Lower Extremity high velocity power training performed at lower external resistance (40% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).', 'armGroupLabels': ['High velocity low force Power Training']}, {'name': 'Low velocity high force Power Training', 'type': 'BEHAVIORAL', 'description': 'Lower extremity low velocity power training performed at high external resistance (70% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).', 'armGroupLabels': ['Low velocity high force Power Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Jean Mayer USDA Human Nutrition Research Center on Aging', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Roger A Fieilding, Ph D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director and Senior Scientist, Professor of Nutrition, Jean Mayer USDA Human Nutrition Research Center on Aging.', 'investigatorFullName': 'Roger A Fielding', 'investigatorAffiliation': 'Tufts University'}}}}