Trial · NCT02938923

Starting a Testosterone and Exercise Program After Hip Injury

NCT02938923, Phase 3, Completed, Washington University School of Medicine; results first posted 2025-02-04

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Starting a Testosterone and Exercise Program After Hip Injury. Trials, record NCT02938923. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02938923

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Starting a Testosterone and Exercise Program After Hip Injury
NCT number: NCT02938923
Status: Completed
Phases: Phase 3
Enrollment: 129 participants, actual
Lead sponsor: Washington University School of Medicine
Conditions: Hip Fracture, Frailty, Sarcopenia
Interventions: Testosterone, Placebo gel, Supervised exercise training, Home exercise program, Health Education Modules
First posted: 2016-10-19
Last updated: 2025-02-04
Results first posted: 2025-02-04

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Six Minute Walk Distance	Baseline to 6 months	Walking endurance was measured using a 6-Minute Walk Distance. Participants were asked to walk back and forth on a measured path marked clearly at both ends for turning purposes, while being told when each minute has passed, and receiving verbal encouragement every 60 seconds. Total distance was measured in meters with higher distances equating to higher walking endurance. Each individual participant distance from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in walking distance. In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Secondary	Change in Total Lean Body Mass	Baseline to 6 months	Total lean body mass measured by dual x-ray absorptiometry (DXA). Baseline DXA scans were completed prior to the first administration of study drug. All scans were completed prior to exercise or 1-RM measurements if scheduled for the same day. DXA scans were reviewed for quality control, proper positioning, and artifacts centrally. Each individual participant measure from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more gains in total lean body mass. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. DXA was not performed at 3 months.
Secondary	Change in Appendicular Lean Body Mass	Baseline to 6 months	Lean body mass of the arms and legs, measured by dual x-ray absorptiometry (DXA). Baseline DXA scans were completed prior to the first administration of study drug. All scans were completed prior to exercise or 1-RM measurements if scheduled for the same day. DXA scans were reviewed for quality control, proper positioning, and artifacts centrally. Each individual participant measure from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more gains in appendicular lean body mass. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. DXA was not performed at 3 months.
Secondary	Change in 1-repetition Maximum (1-RM) Leg Press Strength	Baseline to 6 months	Muscle strength measured as the maximal amount of weight that the participant was able to lift for one repetition (1-RM). The 1-RM is defined as the greatest resistance that could be overcome through a defined range of motion using proper techniques. Subjects were asked to move against progressively heavier resistance loads until a repetition failure was achieved. Each individual participant measure from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent the increased ability to lift more weight. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Secondary	Change in Total Modified Physical Performance Test (mPPT) Score	Baseline to 6 months	A modified version of the Physical Performance Test (mPPT) was used to measure physical function. Participants were asked to complete 9 standardized tasks (book lift, putting on a lab coat, picking up a penny from the floor, standing balance, standing up five times from a 16-inch chair, 50 foot walk including a turn, 360 degree turn, stair climb for 10 steps, and climbing 2 additional flights of steps) for a total score ranging from 0 (significant impairment) to 36 (excellent functioning). Each individual participant score from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in physical functioning.
Secondary	Change in Short Physical Performance Battery (SPPB) Score	Baseline to 6 months	The Short Physical Performance Battery (SPPB) is a well validated objective physical performance measure used to identify risk for disability. The SPPB consists of: chair rise, progressive Romberg balance, and 4 meter gait speed. Each task was scored (0-4) with a total range of 0-12. Participants who score 0 are unable to complete the tasks and participants with higher scores are considered to have higher functional mobility. Each individual participant score from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in physical performance. In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Secondary	Change in Older Adult Resources and Services (OARS) Activities of Daily Living (ADL) Questionnaire	Baseline to 6 months	The OARS Multidimensional Functional Assessment Questionnaire Activities of Daily Living (ADL) is a standardized, valid and reliable, self-report questionnaire used to determine the effect of services on the functional status of older adults by asking respondents about their ability to perform ADLS on 2 subscales: Basic (BADL) and Instrumental (IADL). Both subscales are scored from 0 (significant impairment) to 14 (excellent functioning). The individual participant score from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in functioning. In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Secondary	Change in Functional Status Questionnaire (FSQ) Total Score	Baseline to 6 months	The Functional Status Questionnaire (FSQ) is a self-reported measure asking about the amount of difficulty a participant experienced when performing daily tasks in the previous 4 weeks. There are a total of 6 subscales, but only the basic ADL and Intermediate ADL were used in the STEP-HI study for a total of 9 items. Scores range from 0 (high amount of difficulty completing tasks) to 36 (no difficulty completing tasks). Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Secondary	Change in Hip Rating Questionnaire Total Score	Baseline to 6 months	The Hip Rating Questionnaire (HRQ) Standardized is a 14-item scale with weighted questions regarding quality of life (pain level and ability to walk) and function (ability to use stairs, put on socks/shoes, use public transportation, bathe, shop, do housework, and get in and out of a chair/bed) related to the hip fracture event. The scale scores range from 16 to 100. Higher scores are associated with less pain, higher function, and better quality of life. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Secondary	Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health	Baseline to 6 months	Patient-Reported Outcomes Measurement Information System (PROMIS®) Global Health instrument is a 10 item self report questionnaire used to measure overall quality of life using 2 summary scores: Physical and Mental Health. Each summary score is standardized to the general population, with the average T-score for the US population being 50 and standard deviation of 10. Each individual participant T-score from Baseline was subtracted from Month 6 T-score to represent change over the length of the study. Higher scores represent larger increases in Physical and Mental Health. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Six Minute Walk Distance	Baseline to 6 months	Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).	Meters	LEAST_SQUARES_MEAN
SECONDARY	Change in Total Lean Body Mass	Baseline to 6 months	Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).	grams	LEAST_SQUARES_MEAN
SECONDARY	Change in Appendicular Lean Body Mass	Baseline to 6 months	Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).	grams	LEAST_SQUARES_MEAN
SECONDARY	Change in 1-repetition Maximum (1-RM) Leg Press Strength	Baseline to 6 months	Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).	pounds	LEAST_SQUARES_MEAN
SECONDARY	Change in Total Modified Physical Performance Test (mPPT) Score	Baseline to 6 months	Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Short Physical Performance Battery (SPPB) Score	Baseline to 6 months	Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Older Adult Resources and Services (OARS) Activities of Daily Living (ADL) Questionnaire	Baseline to 6 months	Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Functional Status Questionnaire (FSQ) Total Score	Baseline to 6 months	Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Hip Rating Questionnaire Total Score	Baseline to 6 months	Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health	Baseline to 6 months	Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).	T-score	LEAST_SQUARES_MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group138

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Six Minute Walk Distance	Exercise + Testosterone (EX + T)	Unadjusted baseline to 6 months	42.69	95% Confidence Interval 26.35 to 59.04	Meters
Change in Six Minute Walk Distance	Exercise + Placebo (EX + P)	Unadjusted baseline to 6 months	40.50	95% Confidence Interval 23.82 to 57.18	Meters
Change in Six Minute Walk Distance	Enhanced Usual Care (EUC)	Unadjusted baseline to 6 months	37.65	95% Confidence Interval 8.29 to 67.02	Meters
Change in Six Minute Walk Distance	Exercise + Testosterone (EX + T)	Baseline to 6 month with covariates	42.38	95% Confidence Interval 24.96 to 59.80	Meters
Change in Six Minute Walk Distance	Exercise + Placebo (EX + P)	Baseline to 6 month with covariates	41.75	95% Confidence Interval 23.98 to 59.52	Meters
Change in Six Minute Walk Distance	Enhanced Usual Care (EUC)	Baseline to 6 month with covariates	33.95	95% Confidence Interval 4.30 to 63.60	Meters
Change in Six Minute Walk Distance	Exercise + Testosterone (EX + T)	Unadjusted baseline to 3 months	24.10	95% Confidence Interval 9.72 to 38.48	Meters
Change in Six Minute Walk Distance	Exercise + Placebo (EX + P)	Unadjusted baseline to 3 months	29.18	95% Confidence Interval 14.37 to 43.99	Meters
Change in Six Minute Walk Distance	Enhanced Usual Care (EUC)	Unadjusted baseline to 3 months	37.60	95% Confidence Interval 12.00 to 63.20	Meters
Change in Six Minute Walk Distance	Exercise + Testosterone (EX + T)	Baseline to 3 months with covariates	24.72	95% Confidence Interval 11.87 to 37.56	Meters

1 to 10 of 138Source ClinicalTrials.gov

See all 138 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Exercise + Testosterone (EX + T)	55
Overall Study	STARTED	Exercise + Placebo (EX + P)	54
Overall Study	STARTED	Enhanced Usual Care (EUC)	20
Overall Study	COMPLETED	Exercise + Testosterone (EX + T)	54
Overall Study	COMPLETED	Exercise + Placebo (EX + P)	51
Overall Study	COMPLETED	Enhanced Usual Care (EUC)	19
Overall Study	NOT COMPLETED	Exercise + Testosterone (EX + T)	1
Overall Study	NOT COMPLETED	Exercise + Placebo (EX + P)	3
Overall Study	NOT COMPLETED	Enhanced Usual Care (EUC)	1

Source ClinicalTrials.gov

Adverse events147

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhea	Gastrointestinal disorders	Exercise + Testosterone (EX + T)	5	54	5
other	Diarrhea	Gastrointestinal disorders	Exercise + Placebo (EX + P)	2	55	3
other	Diarrhea	Gastrointestinal disorders	Enhanced Usual Care (EUC)	0	20	0
other	Nausea	Gastrointestinal disorders	Exercise + Testosterone (EX + T)	5	54	7
other	Nausea	Gastrointestinal disorders	Exercise + Placebo (EX + P)	1	55	2
other	Nausea	Gastrointestinal disorders	Enhanced Usual Care (EUC)	0	20	0
other	Edema	General disorders	Exercise + Testosterone (EX + T)	0	54	0
other	Edema	General disorders	Exercise + Placebo (EX + P)	0	55	0
other	Edema	General disorders	Enhanced Usual Care (EUC)	1	20	1
other	Edema peripheral	General disorders	Exercise + Testosterone (EX + T)	0	54	0

1 to 10 of 147Source ClinicalTrials.gov

See all 147 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Exercise + Testosterone (EX + T)	1	55
Total, all-cause mortality	Exercise + Placebo (EX + P)	0	54
Total, all-cause mortality	Enhanced Usual Care (EUC)	0	20
Total, other adverse events	Exercise + Testosterone (EX + T)	36	54
Total, other adverse events	Exercise + Placebo (EX + P)	24	55
Total, other adverse events	Enhanced Usual Care (EUC)	11	20
Total, serious adverse events	Exercise + Testosterone (EX + T)	7	54
Total, serious adverse events	Exercise + Placebo (EX + P)	3	55
Total, serious adverse events	Enhanced Usual Care (EUC)	1	20

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33716173	BACKGROUND	PubMed
36070134	DERIVED	PubMed
40372752	DERIVED	PubMed
41624165	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01AG051647	Combining Testosterone Therapy and Exercise to Improve Function Post Hip Fracture	BINDER, ELLEN F; FISHER, STEVEN R; KIEL, DOUGLAS P.; MAGAZINER, JAY; SCHECHTMAN, KENNETH B.; VOLPI, ELENA	WASHINGTON UNIVERSITY	NATIONAL INSTITUTE ON AGING	2017 to 2023

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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