Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-31 @ 5:54 PM
Study NCT ID:
NCT00345969
Status:
COMPLETED
Last Update Posted:
2018-02-22
First Post:
2006-06-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D007006', 'term': 'Hypogonadism'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ebinder@wustl.edu', 'phone': '314-286-2707', 'title': 'Ellen F. Binder, MD', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Small number of subjects enrolled, single site trial, included both hip fracture patients and a few patients with elective hip joint replacement.'}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Exercise + Placebo', 'description': 'Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.', 'otherNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Exercise + Testosterone', 'description': 'Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.', 'otherNumAtRisk': 13, 'otherNumAffected': 1, 'seriousNumAtRisk': 13, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Elevated serum PSA level', 'notes': 'Participant had elevated PSA level (7.2 ng/mL) at month 6 of study, which returned to normal at 30-day follow up.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'notes': 'Participant experienced a fall during balance testing; no injury sustained.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'notes': "Participant experienced new onset atrial fibrillation that required acute care hospitalization. The patient's symptoms occurred at rest and were not coincident with performing exercise.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Total Lean Body Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise + Placebo', 'description': 'Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.'}, {'id': 'OG001', 'title': 'Exercise + Testosterone', 'description': 'Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Six Months', 'description': 'Total Lean Mass measured by Dual X-ray Absorptiometry (DXA)', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Skeletal Muscle Strength by 1-RM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise + Placebo', 'description': 'Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.'}, {'id': 'OG001', 'title': 'Exercise + Testosterone', 'description': 'Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.2', 'spread': '33.3', 'groupId': 'OG000'}, {'value': '70.3', 'spread': '37.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Six Months', 'description': 'One-repetition maximum strength for leg extension', 'unitOfMeasure': 'lbs.', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 8 participants in the Exercise+Testosterone group provided Leg Extension 1-RM measurements at baseline and 6-month follow-up.'}, {'type': 'SECONDARY', 'title': 'Change in Isokinetic Leg Extension Torque at 0 Deg/Sec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise + Placebo', 'description': 'Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.'}, {'id': 'OG001', 'title': 'Exercise + Testosterone', 'description': 'Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '18.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Six Months', 'description': 'Leg Extension Torque measured with Cybex dynamometer at 0 deg/sec', 'unitOfMeasure': 'ft/lb', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 10 participants in Exercise+Placebo group, and 8 participants in Exercise+Testosterone group, provided Leg Extension torque measurements at baseline and 6-month follow-up.'}, {'type': 'SECONDARY', 'title': 'Change in Leg Extension Torque at 60 Deg/Sec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise + Placebo', 'description': 'Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.'}, {'id': 'OG001', 'title': 'Exercise + Testosterone', 'description': 'Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '21.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Six Months', 'description': 'Leg Extension Torque measured with Cybex dynamometry at 60 deg/sec', 'unitOfMeasure': 'ft/lb', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 10 participants in the Exercise+Placebo group, and 8 participants in the Exercise+Testosterone group, provided Leg extension torque measurements at baseline and 6 month follow-up.'}, {'type': 'SECONDARY', 'title': 'Change in Total Body Fat Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise + Placebo', 'description': 'Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.'}, {'id': 'OG001', 'title': 'Exercise + Testosterone', 'description': 'Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Six Months', 'description': 'Total Body Fat Mass as measured by DXA', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Femoral Bone Mineral Density (BMD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise + Placebo', 'description': 'Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.'}, {'id': 'OG001', 'title': 'Exercise + Testosterone', 'description': 'Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.008', 'spread': '1.238', 'groupId': 'OG000'}, {'value': '0.084', 'spread': '3.515', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.93', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Six Months', 'description': 'Femoral Bone Mineral Density measured with Dual X-ray Absorptiometry (DXA)', 'unitOfMeasure': 'g/cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 10 participants in the Exercise+Placebo group, and 10 participants in the Exercise+Testosterone group, provided femoral bone density measurements at baseline and the 6 month follow-up.'}, {'type': 'SECONDARY', 'title': 'Change in Total Modified Physical Performance (mPPT) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise + Placebo', 'description': 'Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.'}, {'id': 'OG001', 'title': 'Exercise + Testosterone', 'description': 'Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '4.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.24', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Six Months', 'description': 'The Modified Physical Performance Test (mPPT) is a direct observational test that assesses multiple dimensions of physical function (basic and complex activities of daily living \\[ADL\\]) with different levels of difficulty. The test consists of 9 performance tasks. The total score range is 0-36 (min-max), with higher scores indicating better performance. Sub-scores are assigned for each of 9 item tasks; sub-score range is 0-4 (min-max) with higher scores indicating better performance. The sub-scores are summed to compute the total score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 10 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided baseline and follow-up mPPT measurements.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum Prostate Specific Antigen (PSA) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise + Placebo', 'description': 'Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.'}, {'id': 'OG001', 'title': 'Exercise + Testosterone', 'description': 'Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Six Months', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 10 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum PSA level measurements at baseline and 6 month follow-up.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise + Placebo', 'description': 'Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.'}, {'id': 'OG001', 'title': 'Exercise + Testosterone', 'description': 'Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '4.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Six Months', 'description': 'Percentage of the volume of whole blood composed of Red Blood Cells', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 10 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided hematocrit measurements at baseline and 6-month follow-up.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum Total Cholesterol Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise + Placebo', 'description': 'Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.'}, {'id': 'OG001', 'title': 'Exercise + Testosterone', 'description': 'Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '42.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Six Months', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 9 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum for cholesterol measurements at baseline and 6 months.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum HDL Cholesterol Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise + Placebo', 'description': 'Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.'}, {'id': 'OG001', 'title': 'Exercise + Testosterone', 'description': 'Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Six Months', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 9 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum for HDL cholesterol measurements at baseline and 6 months.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum LDL Cholesterol Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise + Placebo', 'description': 'Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.'}, {'id': 'OG001', 'title': 'Exercise + Testosterone', 'description': 'Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.6', 'spread': '15.3', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '39.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Six Months', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 9 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum for LDL cholesterol measurements at baseline and 6 months.'}, {'type': 'SECONDARY', 'title': 'Change in Serum Testosterone Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise + Placebo', 'description': 'Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.'}, {'id': 'OG001', 'title': 'Exercise + Testosterone', 'description': 'Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.3', 'spread': '72.6', 'groupId': 'OG000'}, {'value': '121.2', 'spread': '235.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Six Months', 'description': 'Total Serum Testosterone Level (ng/mL)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 9 participants in the Exercise+Testosterone group provided serum testosterone levels at baseline and 6-month follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exercise + Placebo', 'description': 'Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.'}, {'id': 'FG001', 'title': 'Exercise + Testosterone', 'description': 'Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were recruited from orthopedic units of local hospitals, rehabilitation facilities (both acute rehabilitation units and SNFs), home care programs, and the community-at-large.', 'preAssignmentDetails': 'Participants were carefully screened for exclusion criteria prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exercise + Placebo', 'description': 'Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.'}, {'id': 'BG001', 'title': 'Exercise + Testosterone', 'description': 'Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '81', 'spread': '4', 'groupId': 'BG000'}, {'value': '77', 'spread': '6', 'groupId': 'BG001'}, {'value': '80', 'spread': '7', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total Modified Physical Performance (mPPT) score', 'classes': [{'categories': [{'measurements': [{'value': '23', 'spread': '4', 'groupId': 'BG000'}, {'value': '26', 'spread': '3', 'groupId': 'BG001'}, {'value': '25', 'spread': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Range 0-36, (min-max); higher scores indicate better physical performance. The Total mPPT score is constructed by summing sub-scores of 9 performance tasks. Sub-scores have a range of 0-4 (min-max); higher sub-scores indicate better performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Testosterone level (ng/dL)', 'classes': [{'categories': [{'measurements': [{'value': '252', 'spread': '71', 'groupId': 'BG000'}, {'value': '248', 'spread': '97', 'groupId': 'BG001'}, {'value': '250', 'spread': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI (kg/m2)', 'classes': [{'categories': [{'measurements': [{'value': '28', 'spread': '3', 'groupId': 'BG000'}, {'value': '29', 'spread': '5', 'groupId': 'BG001'}, {'value': '29', 'spread': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Weight (lbs.)', 'classes': [{'categories': [{'measurements': [{'value': '193', 'spread': '30', 'groupId': 'BG000'}, {'value': '195', 'spread': '38', 'groupId': 'BG001'}, {'value': '194', 'spread': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'lbs.', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Men who completed the intervention and provided baseline and follow-up data for primary outcome measures.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-22', 'studyFirstSubmitDate': '2006-06-27', 'resultsFirstSubmitDate': '2016-01-15', 'studyFirstSubmitQcDate': '2006-06-27', 'lastUpdatePostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-22', 'studyFirstPostDateStruct': {'date': '2006-06-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Serum Prostate Specific Antigen (PSA) Level', 'timeFrame': 'Baseline and Six Months'}, {'measure': 'Change in Hematocrit', 'timeFrame': 'Baseline and Six Months', 'description': 'Percentage of the volume of whole blood composed of Red Blood Cells'}, {'measure': 'Change in Serum Total Cholesterol Level', 'timeFrame': 'Baseline and Six Months'}, {'measure': 'Change in Serum HDL Cholesterol Level', 'timeFrame': 'Baseline and Six Months'}, {'measure': 'Change in Serum LDL Cholesterol Level', 'timeFrame': 'Baseline and Six Months'}], 'primaryOutcomes': [{'measure': 'Mean Change in Total Lean Body Mass', 'timeFrame': 'Baseline and Six Months', 'description': 'Total Lean Mass measured by Dual X-ray Absorptiometry (DXA)'}, {'measure': 'Change in Skeletal Muscle Strength by 1-RM', 'timeFrame': 'Baseline and Six Months', 'description': 'One-repetition maximum strength for leg extension'}], 'secondaryOutcomes': [{'measure': 'Change in Isokinetic Leg Extension Torque at 0 Deg/Sec', 'timeFrame': 'Baseline and Six Months', 'description': 'Leg Extension Torque measured with Cybex dynamometer at 0 deg/sec'}, {'measure': 'Change in Leg Extension Torque at 60 Deg/Sec', 'timeFrame': 'Baseline and Six Months', 'description': 'Leg Extension Torque measured with Cybex dynamometry at 60 deg/sec'}, {'measure': 'Change in Total Body Fat Mass', 'timeFrame': 'Baseline and Six Months', 'description': 'Total Body Fat Mass as measured by DXA'}, {'measure': 'Change in Femoral Bone Mineral Density (BMD)', 'timeFrame': 'Baseline and Six Months', 'description': 'Femoral Bone Mineral Density measured with Dual X-ray Absorptiometry (DXA)'}, {'measure': 'Change in Total Modified Physical Performance (mPPT) Score', 'timeFrame': 'Baseline and Six Months', 'description': 'The Modified Physical Performance Test (mPPT) is a direct observational test that assesses multiple dimensions of physical function (basic and complex activities of daily living \\[ADL\\]) with different levels of difficulty. The test consists of 9 performance tasks. The total score range is 0-36 (min-max), with higher scores indicating better performance. Sub-scores are assigned for each of 9 item tasks; sub-score range is 0-4 (min-max) with higher scores indicating better performance. The sub-scores are summed to compute the total score.'}, {'measure': 'Change in Serum Testosterone Level', 'timeFrame': 'Baseline and Six Months', 'description': 'Total Serum Testosterone Level (ng/mL)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Testosterone Replacement Therapy', 'Physical Frailty', 'Hip Fracture'], 'conditions': ['Physical Frailty', 'Hip Fracture', 'Elective Hip Replacement', 'Hypogonadism']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether exercise training combined with testosterone replacement therapy can improve skeletal muscle strength, and lean mass, to a greater degree than exercise training alone.', 'detailedDescription': 'Decreases in physical abilities, including losses of strength, endurance, balance, and coordination are major causes of disability and loss of independence in older men. Such individuals are at high risk for injurious falls, hospitalization, and use of supportive services. Age-associated testosterone deficiency may contribute to deficits in muscle mass and strength that are common in this patient population.\n\nThe primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether six months of exercise training combined with testosterone replacement therapy can improve skeletal muscle mass and skeletal muscle strength, to a greater degree than six months of exercise training alone.\n\nSecondary study aims are to determine in hypogonadal older men with physical frailty, whether six months of exercise training combined with testosterone replacement therapy can improve physical function, bone mineral density, and quality of life, to a greater degree than six months of exercise training alone.\n\nComparison: Men age 65 years and older who meet criteria for physical frailty and have a serum testosterone level below 350 ng/dl are randomly assigned to one of two groups: 1) transdermal testosterone replacement therapy + supervised exercise training for six months vs. 2) inactive placebo gel + supervised exercise training for six months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male, age 65 years and older\n* Total serum testosterone level \\< 350 ng/dl\n* Total Modified Physical Performance Test Score \\<28\n\nExclusion Criteria:\n\n* Inability to walk 50 feet independently\n* Current use of estrogen, progestin, or androgen containing compound\n* Diagnosis of dementia of severity sufficient to interfere with informed consent or compliance with the protocol, or a score of 11 or greater on the Short Blessed Test of Orientation, Memory and Concentration\n* Visual or hearing impairments that interfere with following directions\n* Cardiopulmonary disease (recent MI, unstable angina or CHF, etc.), neuromuscular impairments, or unstable medical condition that would contraindicate progressive resistance exercise training\n* History of prostate cancer or hormone dependent neoplasia\n* PSA level \\> 4 ng/ml\n* Serum liver transaminase levels of greater than 2 standard deviations above normal\n* Use of drugs for osteoporosis for less than 1 year\n* Current participation in a vigorous exercise or weight-training program more than once per week\n* History of sleep apnea requiring use of CPAP\n* Uncontrolled thyroid disease\n* Diagnosis of cancer within the past 5 years other than superficial skin cancer (squamous or basal cell)\n* hematocrit \\> 50%\n* AUA symptom score \\> 16.\n* History of alcohol or substance abuse\n* Presence of severe facial acne\n* Active symptoms of depression with GDS score \\> 5 and symptoms severe enough to cause \\>5% weight loss in previous 3 months or interfere with research assessments'}, 'identificationModule': {'nctId': 'NCT00345969', 'briefTitle': 'Exercise and Testosterone Therapy in Elderly Men With Physical Frailty', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Exercise and Testosterone Therapy in Elderly Men With Physical Frailty', 'orgStudyIdInfo': {'id': 'HSC 02-1108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transdermal Testosterone gel (1%)', 'description': 'Transdermal testosterone 1% gel (Androgel) provided as 2.5 gm and/or 5 gm gel packets with dose titration and monthly dose adjustments to achieve and maintain serum total testosterone level between 500-900 mg/dL. Gel to be applied daily by participants. Participants are blinded to the contents of the gel packets. Participants in this arm also perform supervised exercise training for 6 months.', 'interventionNames': ['Drug: Transdermal Testosterone gel (1%)', 'Behavioral: Supervised exercise training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo gel', 'description': 'Inactive topical gel identical in appearance to the active medication, provided in packets identical to the packaging for the active medication. Gel to be applied daily by participants. Participants are blinded to the contents of the gel packets. Participants in this arm also perform supervised exercise training for 6 months.', 'interventionNames': ['Behavioral: Supervised exercise training']}], 'interventions': [{'name': 'Transdermal Testosterone gel (1%)', 'type': 'DRUG', 'otherNames': ['Androgel'], 'description': 'Transdermal testosterone replacement therapy with Androgel(TM). Daily application of gel at 5 mg, 7.5 gm, or 10 gm for six months. Target serum total testosterone level between 500-900 ng/dl.', 'armGroupLabels': ['Transdermal Testosterone gel (1%)']}, {'name': 'Supervised exercise training', 'type': 'BEHAVIORAL', 'description': 'Supervised exercise training performed on site at academic medical center exercise facility. Exercise training consisted of 2 months of flexibility, balance, treadmill walking, and physical therapy-type exercises, followed by 4 months of progressive resistance training.', 'armGroupLabels': ['Placebo gel', 'Transdermal Testosterone gel (1%)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Ellen F. Binder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Solvay Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ellen F. Binder, MD', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}