Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-03-08 @ 7:22 PM
Study NCT ID:
NCT00112151
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2005-05-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TEAM: Testosterone Supplementation and Exercise in Elderly Men
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}, {'id': 'D055070', 'term': 'Resistance Training'}], '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'}, {'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'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robert.schwartz@ucdenver.edu', 'phone': '303-724-1919', 'title': 'Dr. Robert S. Schwartz, Head, Division of Geriatric Medicine', 'organization': 'Univeristy of Colorado at Denver'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo gel with or without progressive resistance training', 'otherNumAtRisk': 47, 'otherNumAffected': 23, 'seriousNumAtRisk': 47, 'seriousNumAffected': 30}, {'id': 'EG001', 'title': 'Lower-range T', 'description': 'T gel supplementation targeting a total serum T concentration of 400-550ng/dL, with our without progressive resistance training', 'otherNumAtRisk': 47, 'otherNumAffected': 14, 'seriousNumAtRisk': 47, 'seriousNumAffected': 33}, {'id': 'EG002', 'title': 'Higher-range T', 'description': 'T gel supplementation targeting a total serum T concentration of 600-1000ng/dL, with our without progressive resistance training', 'otherNumAtRisk': 49, 'otherNumAffected': 25, 'seriousNumAtRisk': 49, 'seriousNumAffected': 38}], 'otherEvents': [{'term': 'Persistently elevated HCT >= 54%', 'notes': 'Polycythemia or persistent elevated hematocrit \\>= 54%', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Persistently elevated PSA', 'notes': 'Persistent elevated PSA representing an increase of \\>=0.75 ng/mL over baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated AUA', 'notes': 'American Urological Association (AUA) BPH Symptom Score Index \\>= 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Persistently elevated liver function tests', 'notes': 'Alanine aminotransferase or aspartate aminotransferase \\> 2 times the upper limit of normal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Daytime somnolence/hypoxia', 'notes': 'Somnolence = Epworth Sleepiness Score \\> 16; hypoxia is daytime arterial oxygen saturation by pulse oximetry \\< 88%', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other nonserious adverse events', 'notes': 'Other nonserious adverse events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Total serious cardiovascular adverse events', 'notes': 'Includes acute coronary syndrome, arrhythmia, aortic aneurysm, syncope/presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other noncardiovascular serious adverse events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 53, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 55, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 64, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Physical Function (CS-PFP Total Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + No PRT', 'description': 'Placebo gel; no exercise'}, {'id': 'OG001', 'title': 'Placebo + PRT', 'description': 'Placebo gel plus progressive resistance training'}, {'id': 'OG002', 'title': 'Any T + No PRT', 'description': 'T gel supplementation (lower or higher-range); no exercise'}, {'id': 'OG003', 'title': 'Any T + PRT', 'description': 'T gel supplementation (lower or higher-range) plus progressive resistance training'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '8.0', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '7.3', 'groupId': 'OG002'}, {'value': '3.3', 'spread': '7.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.025', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A one-sided P-value of \\<0.025 was used to define statistical significance', 'groupDescription': 'As prespecified, the lower- and higher-range T groups were combined (any T). The primary analysis was conducted in the PRT groups and compared CS-PFP at 12 months with any T to placebo, adjusted for baseline CS-PFP score.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.025', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A one-sided P-value of \\<0.025 was used to define statistical significance.', 'groupDescription': 'As prespecified, the lower- and higher-range T groups were combined (any T). To address whether the effects of any T on physical function are the same without PRT, the analysis was also conducted in the No PRT groups, comparing CS-PFP at 12 months with any T to placebo, adjusted for baseline CS-PFP score.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'Continuous-scale physical function performance test (CS-PFP) which comprises 15 everyday tasks requiring upper and lower body strength and flexibility, balance, coordination and endurance. The CS-PFP was developed to measure performance in higher functioning adults with minimal floor or ceiling effects, and is valid, reliable and sensitive to change. Total and domain scores are scaled from 0 to 100, with higher scores indicating better function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Upper Body Muscle Strength (1-RM, kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + No PRT', 'description': 'Placebo gel; no exercise'}, {'id': 'OG001', 'title': 'Placebo + PRT', 'description': 'Placebo gel plus progressive resistance training'}, {'id': 'OG002', 'title': 'Any T + No PRT', 'description': 'T gel supplementation (lower- or higher-range); no exercise'}, {'id': 'OG003', 'title': 'Any T + PRT', 'description': 'T gel supplementation (lower- or higher-range) plus progressive resistance training'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '25.5', 'spread': '11.3', 'groupId': 'OG001'}, {'value': '7.8', 'spread': '6.9', 'groupId': 'OG002'}, {'value': '24.3', 'spread': '11.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average upper body strength with any T to placebo in subjects assigned to PRT.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average upper body strength with any T to placebo in subjects assigned to no PRT.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The maximal weight a participant could lift once (1-repetition maximum, 1-RM) was assessed at baseline and 12 months. The average of the difference from baseline in 4 upper-body 1-RM measures (bench press,incline press, overhead pull-down, and seated row) are represented.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lower Body Muscle Strength (1-RM, kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + No PRT', 'description': 'Placebo gel; no exercise'}, {'id': 'OG001', 'title': 'Placebo + PRT', 'description': 'Placebo gel plus progressive resistance training'}, {'id': 'OG002', 'title': 'Any T + No PRT', 'description': 'T gel supplementation (lower- or higher-range); no exercise'}, {'id': 'OG003', 'title': 'Any T + PRT', 'description': 'T gel supplementation (lower- or higher-range) plus progressive resistance training'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '27.0', 'spread': '17.0', 'groupId': 'OG001'}, {'value': '10.5', 'spread': '10.9', 'groupId': 'OG002'}, {'value': '28.0', 'spread': '19.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average lower body strength with any T to placebo in subjects assigned to PRT.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average lower body strength with any T to placebo in subjects assigned to no PRT.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The maximal weight a participant could lift once \\[1-repetition maximum, 1-RM\\] was assessed at baseline and 12 months. The average of the difference from baseline in 3 lower-body 1-RM measures (knee extension, knee flexion, and seated leg press)) are represented.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Power (Power Rig, Watts)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + No PRT', 'description': 'Placebo gel; no exercise'}, {'id': 'OG001', 'title': 'Placebo + PRT', 'description': 'Placebo gel plus progressive resistance training'}, {'id': 'OG002', 'title': 'Any T + No PRT', 'description': 'T gel supplementation (lower- or higher-range); no exercise'}, {'id': 'OG003', 'title': 'Any T + PRT', 'description': 'T gel supplementation (lower- or higher-range) plus progressive resistance training'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '34.6', 'groupId': 'OG000'}, {'value': '24.3', 'spread': '62.0', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '36.9', 'groupId': 'OG002'}, {'value': '5.1', 'spread': '51.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in leg extensor power with any T to placebo in subjects assigned to PRT.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in leg extensor power with any T to placebo in subjects assigned to no PRT.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'Leg extensor power was evaluated using a Nottingham leg extensor power rig (watts).', 'unitOfMeasure': 'Watts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fat Mass (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + No PRT', 'description': 'Placebo gel; no exercise'}, {'id': 'OG001', 'title': 'Placebo + PRT', 'description': 'Placebo gel plus progressive resistance training'}, {'id': 'OG002', 'title': 'Any T + No PRT', 'description': 'T gel supplementation (lower- or higher-range); no exercise'}, {'id': 'OG003', 'title': 'Any T + PRT', 'description': 'T gel supplementation (lower- or higher-range) plus progressive resistance training'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '2.3', 'groupId': 'OG002'}, {'value': '-1.8', 'spread': '2.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to PRT.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to no PRT.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'Total change in Fat mass (kg) as evaluated by DXA', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fat Free Mass (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + No PRT', 'description': 'Placebo gel; no exercise'}, {'id': 'OG001', 'title': 'Placebo + PRT', 'description': 'Placebo gel plus progressive resistance training'}, {'id': 'OG002', 'title': 'Any T + No PRT', 'description': 'T gel supplementation (lower- or higher-range); no exercise'}, {'id': 'OG003', 'title': 'Any T + PRT', 'description': 'T gel supplementation (lower- or higher-range) plus progressive resistance training'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '2.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat free mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to PRT.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat free mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to no PRT.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'Total change in Fat free mass (kg) as evaluated by DXA', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LowT+Resistance Training', 'description': 'Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)\n\n1 year standard Progressive Resistance Training(PRT) program'}, {'id': 'FG001', 'title': 'LowT+No Resistance Training', 'description': 'Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)\n\nNo exercise program'}, {'id': 'FG002', 'title': 'HighT+Resistance Training', 'description': 'High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)\n\n1 year standard Progressive Resistance Training(PRT) program'}, {'id': 'FG003', 'title': 'HighT+No Resistance Training', 'description': 'High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)\n\nNo exercise program'}, {'id': 'FG004', 'title': 'Placebo+Resistance Training', 'description': 'Placebo Group applies two 2.5 gm placebo packets\n\n1 year standard Progressive Resistance Training(PRT) program'}, {'id': 'FG005', 'title': 'Placebo+No Resistance Training', 'description': 'Placebo group applies two 2.5 gm placebo packets\n\nNo exercise program'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '28'}, {'groupId': 'FG005', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '22'}, {'groupId': 'FG005', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Recruitment from January 2005 through August 2009 of community dwelling men \\>=60 years of age in the Denver metropolitan area with active attempts to recruit men from all ethnic populations.', 'preAssignmentDetails': 'see eligibility criteria'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '167', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'LowT+Resistance Training', 'description': 'Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)\n\n1 year standard Progressive Resistance Training(PRT) program'}, {'id': 'BG001', 'title': 'LowT+No Resistance Training', 'description': 'Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)\n\nNo exercise program'}, {'id': 'BG002', 'title': 'HighT+Resistance Training', 'description': 'High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)\n\n1 year standard Progressive Resistance Training(PRT) program'}, {'id': 'BG003', 'title': 'HighT+No Resistance Training', 'description': 'High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)\n\nNo exercise program'}, {'id': 'BG004', 'title': 'Placebo+Resistance Training', 'description': 'Placebo Group applies two 2.5 gm placebo packets\n\n1 year standard Progressive Resistance Training(PRT) program'}, {'id': 'BG005', 'title': 'Placebo+No Resistance Training', 'description': 'Placebo group applies two 2.5 gm placebo packets\n\nNo exercise program'}, {'id': 'BG006', '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'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '82', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '85', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.3', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '65.6', 'spread': '4.5', 'groupId': 'BG001'}, {'value': '64.3', 'spread': '4.6', 'groupId': 'BG002'}, {'value': '65.3', 'spread': '5.5', 'groupId': 'BG003'}, {'value': '64.7', 'spread': '4.5', 'groupId': 'BG004'}, {'value': '66.6', 'spread': '5.4', 'groupId': 'BG005'}, {'value': '65.7', 'spread': '5.5', 'groupId': 'BG006'}]}]}], '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'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '167', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '167', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-19', 'studyFirstSubmitDate': '2005-05-27', 'resultsFirstSubmitDate': '2015-11-04', 'studyFirstSubmitQcDate': '2005-05-27', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-12-14', 'studyFirstPostDateStruct': {'date': '2005-05-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Function (CS-PFP Total Score)', 'timeFrame': 'Baseline and 12 months', 'description': 'Continuous-scale physical function performance test (CS-PFP) which comprises 15 everyday tasks requiring upper and lower body strength and flexibility, balance, coordination and endurance. The CS-PFP was developed to measure performance in higher functioning adults with minimal floor or ceiling effects, and is valid, reliable and sensitive to change. Total and domain scores are scaled from 0 to 100, with higher scores indicating better function.'}], 'secondaryOutcomes': [{'measure': 'Upper Body Muscle Strength (1-RM, kg)', 'timeFrame': 'Baseline and 12 months', 'description': 'The maximal weight a participant could lift once (1-repetition maximum, 1-RM) was assessed at baseline and 12 months. The average of the difference from baseline in 4 upper-body 1-RM measures (bench press,incline press, overhead pull-down, and seated row) are represented.'}, {'measure': 'Lower Body Muscle Strength (1-RM, kg)', 'timeFrame': 'Baseline and 12 months', 'description': 'The maximal weight a participant could lift once \\[1-repetition maximum, 1-RM\\] was assessed at baseline and 12 months. The average of the difference from baseline in 3 lower-body 1-RM measures (knee extension, knee flexion, and seated leg press)) are represented.'}, {'measure': 'Power (Power Rig, Watts)', 'timeFrame': 'Baseline and 12 months', 'description': 'Leg extensor power was evaluated using a Nottingham leg extensor power rig (watts).'}, {'measure': 'Fat Mass (kg)', 'timeFrame': 'Baseline and 12 months', 'description': 'Total change in Fat mass (kg) as evaluated by DXA'}, {'measure': 'Fat Free Mass (kg)', 'timeFrame': 'Baseline and 12 months', 'description': 'Total change in Fat free mass (kg) as evaluated by DXA'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['andropause', 'hypogonadism', 'AndroGel', 'exercise', 'PRT', 'Testosterone', 'T supplementation'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '2229940', 'type': 'BACKGROUND', 'citation': 'Schwartz RS, Shuman WP, Bradbury VL, Cain KC, Fellingham GW, Beard JC, Kahn SE, Stratton JR, Cerqueira MD, Abrass IB. Body fat distribution in healthy young and older men. J Gerontol. 1990 Nov;45(6):M181-5. doi: 10.1093/geronj/45.6.m181.'}, {'pmid': '7552755', 'type': 'BACKGROUND', 'citation': 'Porter MM, Vandervoort AA, Lexell J. Aging of human muscle: structure, function and adaptability. Scand J Med Sci Sports. 1995 Jun;5(3):129-42. doi: 10.1111/j.1600-0838.1995.tb00026.x.'}, {'pmid': '8601053', 'type': 'BACKGROUND', 'citation': 'Jolles J, Verhey FR, Riedel WJ, Houx PJ. Cognitive impairment in elderly people. Predisposing factors and implications for experimental drug studies. Drugs Aging. 1995 Dec;7(6):459-79. doi: 10.2165/00002512-199507060-00006.'}, {'pmid': '6602143', 'type': 'BACKGROUND', 'citation': 'Davidson JM, Chen JJ, Crapo L, Gray GD, Greenleaf WJ, Catania JA. Hormonal changes and sexual function in aging men. J Clin Endocrinol Metab. 1983 Jul;57(1):71-7. doi: 10.1210/jcem-57-1-71.'}, {'pmid': '9224429', 'type': 'BACKGROUND', 'citation': 'Vitiello MV. Sleep disorders and aging: understanding the causes. J Gerontol A Biol Sci Med Sci. 1997 Jul;52(4):M189-91. doi: 10.1093/gerona/52a.4.m189. No abstract available.'}, {'pmid': '8684716', 'type': 'BACKGROUND', 'citation': 'Myers BL, Badia P. Changes in circadian rhythms and sleep quality with aging: mechanisms and interventions. Neurosci Biobehav Rev. 1995 Winter;19(4):553-71. doi: 10.1016/0149-7634(95)00018-6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of testosterone supplementation (AndroGel) on body composition, strength, endurance, cognition, and function in older men.', 'detailedDescription': 'Studies suggest that testosterone (T) replacement in healthy elderly men has beneficial effects on body composition, muscle, bone, memory, and behavior, but the risks of chronic treatment, especially on the prostate, heart, and sleep quality, are not entirely clear. Therefore, it is most desirable to supplement into the lowest "effective" range in elderly men. However, the effects of lower than usual replacement T doses have not been well studied. Furthermore, the possible important interaction of exercise to enhance the positive effects of T supplementation, yet mitigate the possible side effects, has not been studied in older men.\n\nThis one-year study will enroll 150 men with low-normal to slightly below normal serum total T levels. Participants will be randomized into one of 6 treatment groups to receive T supplementation (AndroGel) of 25mg/day, 50 mg/day or a placebo crossed with progressive resistance training (PRT) exercise 3 times a week versus none. At the end of the study, participants in the exercise-control group will be offered PRT.\n\nPlease see link below for updated version of full protocol.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy, untrained men 60 years or older with low-normal testosterone levels (200-350ng/dL)\n* Must reside in the Denver metro area\n\nExclusion Criteria:\n\n* Prostate/breast cancer\n* Unable to exercise safely\n* severe obesity (\\>34 body mass index \\[BMI\\])\n* Polycythemia\n* Diabetes\n* Use of drugs that could affect T levels\n* Cognitive dysfunction (MMSE less than 24)\n* PSA above the age-adjusted normal level or AUA greater than 19\n* Unable to pass stress test due to active CAD'}, 'identificationModule': {'nctId': 'NCT00112151', 'briefTitle': 'TEAM: Testosterone Supplementation and Exercise in Elderly Men', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Testosterone Supplementation and Exercise in Elderly Men', 'orgStudyIdInfo': {'id': '02-1056'}, 'secondaryIdInfos': [{'id': 'R01AG019339', 'link': 'https://reporter.nih.gov/quickSearch/R01AG019339', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LowT+Resistance Training', 'description': 'Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)\n\n1 year standard Progressive Resistance Training(PRT) program', 'interventionNames': ['Drug: LowT', 'Behavioral: Resistance Training']}, {'type': 'EXPERIMENTAL', 'label': 'LowT+No Resistance training', 'description': 'Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)\n\nNo exercise program', 'interventionNames': ['Drug: LowT']}, {'type': 'EXPERIMENTAL', 'label': 'HighT+Resistance Training', 'description': 'High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)\n\n1 year standard Progressive Resistance Training(PRT) program', 'interventionNames': ['Behavioral: Resistance Training', 'Drug: HighT']}, {'type': 'EXPERIMENTAL', 'label': 'HighT+No Resistance Training', 'description': 'High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)\n\nNo exercise program', 'interventionNames': ['Drug: HighT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo+Resistance Training', 'description': 'Placebo Group applies two 2.5 gm placebo packets\n\n1 year standard Progressive Resistance Training(PRT) program', 'interventionNames': ['Behavioral: Resistance Training', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo+No Resistance Training', 'description': 'Placebo group applies two 2.5 gm placebo packets\n\nNo exercise program', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LowT', 'type': 'DRUG', 'otherNames': ['Androgel'], 'description': 'Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)during the first 12 weeks. Total exposure duration is 52 weeks.', 'armGroupLabels': ['LowT+No Resistance training', 'LowT+Resistance Training']}, {'name': 'Resistance Training', 'type': 'BEHAVIORAL', 'otherNames': ['PRT', 'Progressive resistance training'], 'description': 'Weight training 45-60 minutes 3 times per week', 'armGroupLabels': ['HighT+Resistance Training', 'LowT+Resistance Training', 'Placebo+Resistance Training']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.', 'armGroupLabels': ['Placebo+No Resistance Training', 'Placebo+Resistance Training']}, {'name': 'HighT', 'type': 'DRUG', 'otherNames': ['Androgel'], 'description': 'High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)during the first 12 weeks. Total exposure duration is 52 weeks.', 'armGroupLabels': ['HighT+No Resistance Training', 'HighT+Resistance Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Health Sciences Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Robert S. Schwartz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}