Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00345969
• Collaborator: Solvay Pharmaceuticals (Industry)
• Enrollment: 25
• Location: 1
• Arms: 2
• Duration (Months): 57
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Physical Frailty; Hip Fracture; Elective Hip Replacement; Hypogonadism	Drug: Transdermal Testosterone gel (1%); Behavioral: Supervised exercise training	Phase 3

Detailed Description

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.

The 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.

Secondary 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.

Comparison: 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
• Study Start Date: Nov 1, 2004
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Transdermal Testosterone gel (1%) 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.	Drug: Transdermal Testosterone gel (1%); 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.; Other Names: Androgel ; Behavioral: Supervised exercise training; 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.
Placebo Comparator: Placebo gel 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.	Behavioral: Supervised exercise training; 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.

Outcome Measures

Primary Outcome Measures

1. Mean Change in Total Lean Body Mass [Baseline and Six Months]

   Total Lean Mass measured by Dual X-ray Absorptiometry (DXA)

2. Change in Skeletal Muscle Strength by 1-RM [Baseline and Six Months]

   One-repetition maximum strength for leg extension

Secondary Outcome Measures

1. Change in Isokinetic Leg Extension Torque at 0 Deg/Sec [Baseline and Six Months]

   Leg Extension Torque measured with Cybex dynamometer at 0 deg/sec

2. Change in Leg Extension Torque at 60 Deg/Sec [Baseline and Six Months]

   Leg Extension Torque measured with Cybex dynamometry at 60 deg/sec

3. Change in Total Body Fat Mass [Baseline and Six Months]

   Total Body Fat Mass as measured by DXA

4. Change in Femoral Bone Mineral Density (BMD) [Baseline and Six Months]

   Femoral Bone Mineral Density measured with Dual X-ray Absorptiometry (DXA)

5. Change in Total Modified Physical Performance (mPPT) Score [Baseline and Six Months]

   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.

6. Change in Serum Testosterone Level [Baseline and Six Months]

   Total Serum Testosterone Level (ng/mL)

Other Outcome Measures

1. Change in Serum Prostate Specific Antigen (PSA) Level [Baseline and Six Months]

2. Change in Hematocrit [Baseline and Six Months]

   Percentage of the volume of whole blood composed of Red Blood Cells

3. Change in Serum Total Cholesterol Level [Baseline and Six Months]

4. Change in Serum HDL Cholesterol Level [Baseline and Six Months]

5. Change in Serum LDL Cholesterol Level [Baseline and Six Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male, age 65 years and older

• Total serum testosterone level < 350 ng/dl

• Total Modified Physical Performance Test Score <28

Exclusion Criteria:

• Inability to walk 50 feet independently

• Current use of estrogen, progestin, or androgen containing compound

• 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

• Visual or hearing impairments that interfere with following directions

• Cardiopulmonary disease (recent MI, unstable angina or CHF, etc.), neuromuscular impairments, or unstable medical condition that would contraindicate progressive resistance exercise training

• History of prostate cancer or hormone dependent neoplasia

• PSA level > 4 ng/ml

• Serum liver transaminase levels of greater than 2 standard deviations above normal

• Use of drugs for osteoporosis for less than 1 year

• Current participation in a vigorous exercise or weight-training program more than once per week

• History of sleep apnea requiring use of CPAP

• Uncontrolled thyroid disease

• Diagnosis of cancer within the past 5 years other than superficial skin cancer (squamous or basal cell)

• hematocrit > 50%

• AUA symptom score > 16.

• History of alcohol or substance abuse

• Presence of severe facial acne

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine
• Solvay Pharmaceuticals

Investigators

• Principal Investigator: Ellen F. Binder, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ellen F. Binder, MD, Professor, Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT00345969
• Other Study ID Numbers: HSC 02-1108
• First Posted: Jun 29, 2006
• Last Update Posted: Feb 22, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Ellen F. Binder, MD, Professor, Washington University School of Medicine: Testosterone Replacement Therapy; Physical Frailty; Hip Fracture
• Additional relevant MeSH terms: Hypogonadism; Frailty; Hip Fractures; Testosterone

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	Participants were carefully screened for exclusion criteria prior to randomization.

Arm/Group Title	Exercise + Placebo	Exercise + Testosterone
Arm/Group 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.	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.
Period Title: Overall Study
STARTED	12	13
COMPLETED	11	11
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Exercise + Placebo	Exercise + Testosterone	Total
Arm/Group 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.	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.	Total of all reporting groups
Overall Participants	11	11	22
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	81 (4)	77 (6)	80 (7)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	11 100%	11 100%	22 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	2 18.2%	2 9.1%
White	11 100%	9 81.8%	20 90.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Total Modified Physical Performance (mPPT) score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	23 (4)	26 (3)	25 (4)
Total Testosterone level (ng/dL) (ng/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ng/dL]	252 (71)	248 (97)	250 (84)
BMI (kg/m2) (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	28 (3)	29 (5)	29 (4)
Body Weight (lbs.) (lbs.) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [lbs.]	193 (30)	195 (38)	194 (34)

Outcome Measures

1. Primary Outcome

Title	Mean Change in Total Lean Body Mass
Description	Total Lean Mass measured by Dual X-ray Absorptiometry (DXA)
Time Frame	Baseline and Six Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise + Placebo	Exercise + Testosterone
Arm/Group 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.	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.
Measure Participants	11	11
Mean (Standard Deviation) [kg]	0.5 (1.8)	2.3 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise + Placebo, Exercise + Testosterone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	ANOVA
	Comments

2. Primary Outcome

Title	Change in Skeletal Muscle Strength by 1-RM
Description	One-repetition maximum strength for leg extension
Time Frame	Baseline and Six Months

Outcome Measure Data

Analysis Population Description

Only 8 participants in the Exercise+Testosterone group provided Leg Extension 1-RM measurements at baseline and 6-month follow-up.

Arm/Group Title	Exercise + Placebo	Exercise + Testosterone
Arm/Group 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.	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.
Measure Participants	11	8
Mean (Standard Deviation) [lbs.]	59.2 (33.3)	70.3 (37.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise + Placebo, Exercise + Testosterone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.55
	Comments
	Method	ANOVA
	Comments

3. Secondary Outcome

Title	Change in Isokinetic Leg Extension Torque at 0 Deg/Sec
Description	Leg Extension Torque measured with Cybex dynamometer at 0 deg/sec
Time Frame	Baseline and Six Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Exercise + Placebo	Exercise + Testosterone
Arm/Group 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.	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.
Measure Participants	10	8
Mean (Standard Deviation) [ft/lb]	10.4 (14.2)	19.8 (18.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise + Placebo, Exercise + Testosterone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.23
	Comments
	Method	ANOVA
	Comments

4. Secondary Outcome

Title	Change in Leg Extension Torque at 60 Deg/Sec
Description	Leg Extension Torque measured with Cybex dynamometry at 60 deg/sec
Time Frame	Baseline and Six Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Exercise + Placebo	Exercise + Testosterone
Arm/Group 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.	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.
Measure Participants	10	8
Mean (Standard Deviation) [ft/lb]	12.7 (13.5)	19.4 (21.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise + Placebo, Exercise + Testosterone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.43
	Comments
	Method	ANOVA
	Comments

5. Secondary Outcome

Title	Change in Total Body Fat Mass
Description	Total Body Fat Mass as measured by DXA
Time Frame	Baseline and Six Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise + Placebo	Exercise + Testosterone
Arm/Group 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.	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.
Measure Participants	11	11
Mean (Standard Deviation) [kg]	-0.51 (0.96)	-1.1 (1.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise + Placebo, Exercise + Testosterone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.33
	Comments
	Method	ANOVA
	Comments

6. Secondary Outcome

Title	Change in Femoral Bone Mineral Density (BMD)
Description	Femoral Bone Mineral Density measured with Dual X-ray Absorptiometry (DXA)
Time Frame	Baseline and Six Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Exercise + Placebo	Exercise + Testosterone
Arm/Group 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.	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.
Measure Participants	10	10
Mean (Standard Deviation) [g/cm2]	-0.008 (1.238)	0.084 (3.515)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise + Placebo, Exercise + Testosterone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.93
	Comments
	Method	ANOVA
	Comments

7. Secondary Outcome

Title	Change in Total Modified Physical Performance (mPPT) Score
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.
Time Frame	Baseline and Six Months

Outcome Measure Data

Analysis Population Description

Only 10 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided baseline and follow-up mPPT measurements.

Arm/Group Title	Exercise + Placebo	Exercise + Testosterone
Arm/Group 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.	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.
Measure Participants	10	9
Mean (Standard Deviation) [units on a scale]	5.0 (3.7)	2.8 (4.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise + Placebo, Exercise + Testosterone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.24
	Comments
	Method	ANOVA
	Comments

8. Other Pre-specified Outcome

Title	Change in Serum Prostate Specific Antigen (PSA) Level
Time Frame	Baseline and Six Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Exercise + Placebo	Exercise + Testosterone
Arm/Group 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.	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.
Measure Participants	10	9
Mean (Standard Deviation) [ng/mL]	0.05 (0.27)	0.21 (0.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise + Placebo, Exercise + Testosterone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.49
	Comments
	Method	ANOVA
	Comments

9. Other Pre-specified Outcome

Title	Change in Hematocrit
Description	Percentage of the volume of whole blood composed of Red Blood Cells
Time Frame	Baseline and Six Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Exercise + Placebo	Exercise + Testosterone
Arm/Group 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.	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.
Measure Participants	10	9
Mean (Standard Deviation) [percent]	0.14 (2.6)	2.5 (4.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise + Placebo, Exercise + Testosterone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.19
	Comments
	Method	ANOVA
	Comments

10. Other Pre-specified Outcome

Title	Change in Serum Total Cholesterol Level
Time Frame	Baseline and Six Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Exercise + Placebo	Exercise + Testosterone
Arm/Group 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.	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.
Measure Participants	9	9
Mean (Standard Deviation) [mg/dL]	-3.2 (15.4)	-9.0 (42.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise + Placebo, Exercise + Testosterone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.71
	Comments
	Method	ANOVA
	Comments

11. Other Pre-specified Outcome

Title	Change in Serum HDL Cholesterol Level
Time Frame	Baseline and Six Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Exercise + Placebo	Exercise + Testosterone
Arm/Group 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.	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.
Measure Participants	9	9
Mean (Standard Deviation) [mg/dL]	-1.4 (9.0)	1.7 (7.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise + Placebo, Exercise + Testosterone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments
	Method	ANOVA
	Comments

12. Other Pre-specified Outcome

Title	Change in Serum LDL Cholesterol Level
Time Frame	Baseline and Six Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Exercise + Placebo	Exercise + Testosterone
Arm/Group 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.	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.
Measure Participants	9	9
Mean (Standard Deviation) [mg/dL]	-3.6 (15.3)	-1.6 (39.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise + Placebo, Exercise + Testosterone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.89
	Comments
	Method	ANOVA
	Comments

13. Secondary Outcome

Title	Change in Serum Testosterone Level
Description	Total Serum Testosterone Level (ng/mL)
Time Frame	Baseline and Six Months

Outcome Measure Data

Analysis Population Description

Only 9 participants in the Exercise+Testosterone group provided serum testosterone levels at baseline and 6-month follow-up.

Arm/Group Title	Exercise + Placebo	Exercise + Testosterone
Arm/Group 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.	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.
Measure Participants	11	9
Mean (Standard Deviation) [ng/mL]	-15.3 (72.6)	121.2 (235.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise + Placebo, Exercise + Testosterone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.13
	Comments
	Method	ANOVA
	Comments

Adverse Events

Time Frame	12 months
Arm/Group Title	Exercise + Placebo		Exercise + Testosterone
Arm/Group 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.		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.
All Cause Mortality
	Exercise + Placebo		Exercise + Testosterone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Exercise + Placebo		Exercise + Testosterone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		1/13 (7.7%)
Cardiac disorders
Atrial fibrillation	0/12 (0%)	0	1/13 (7.7%)	1
Other (Not Including Serious) Adverse Events
	Exercise + Placebo		Exercise + Testosterone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)		1/13 (7.7%)
General disorders
Fall	1/12 (8.3%)	1	0/13 (0%)	0
Renal and urinary disorders
Elevated serum PSA level	0/12 (0%)	0	1/13 (7.7%)	1

Limitations/Caveats

Small number of subjects enrolled, single site trial, included both hip fracture patients and a few patients with elective hip joint replacement.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.