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Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

Primary Purpose

Physical Frailty, Hip Fracture, Elective Hip Replacement

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Transdermal Testosterone gel (1%)
Supervised exercise training
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Frailty focused on measuring Testosterone Replacement Therapy, Physical Frailty, Hip Fracture

Eligibility Criteria

65 Years - undefined (Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Transdermal Testosterone gel (1%)

Placebo gel

Arm 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.

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.

Outcomes

Primary Outcome Measures

Mean Change in Total Lean Body Mass
Total Lean Mass measured by Dual X-ray Absorptiometry (DXA)
Change in Skeletal Muscle Strength by 1-RM
One-repetition maximum strength for leg extension

Secondary Outcome Measures

Change in Isokinetic Leg Extension Torque at 0 Deg/Sec
Leg Extension Torque measured with Cybex dynamometer at 0 deg/sec
Change in Leg Extension Torque at 60 Deg/Sec
Leg Extension Torque measured with Cybex dynamometry at 60 deg/sec
Change in Total Body Fat Mass
Total Body Fat Mass as measured by DXA
Change in Femoral Bone Mineral Density (BMD)
Femoral Bone Mineral Density measured with Dual X-ray Absorptiometry (DXA)
Change in Total Modified Physical Performance (mPPT) Score
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.
Change in Serum Testosterone Level
Total Serum Testosterone Level (ng/mL)

Full Information

First Posted
June 27, 2006
Last Updated
January 22, 2018
Sponsor
Washington University School of Medicine
Collaborators
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00345969
Brief Title
Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Official Title
Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Frailty, Hip Fracture, Elective Hip Replacement, Hypogonadism
Keywords
Testosterone Replacement Therapy, Physical Frailty, Hip Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transdermal Testosterone gel (1%)
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo gel
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Transdermal Testosterone gel (1%)
Other Intervention Name(s)
Androgel
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Supervised exercise training
Intervention 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.
Primary Outcome Measure Information:
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
Title
Change in Skeletal Muscle Strength by 1-RM
Description
One-repetition maximum strength for leg extension
Time Frame
Baseline and Six Months
Secondary Outcome Measure Information:
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
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
Title
Change in Total Body Fat Mass
Description
Total Body Fat Mass as measured by DXA
Time Frame
Baseline and Six Months
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
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
Title
Change in Serum Testosterone Level
Description
Total Serum Testosterone Level (ng/mL)
Time Frame
Baseline and Six Months
Other Pre-specified Outcome Measures:
Title
Change in Serum Prostate Specific Antigen (PSA) Level
Time Frame
Baseline and Six Months
Title
Change in Hematocrit
Description
Percentage of the volume of whole blood composed of Red Blood Cells
Time Frame
Baseline and Six Months
Title
Change in Serum Total Cholesterol Level
Time Frame
Baseline and Six Months
Title
Change in Serum HDL Cholesterol Level
Time Frame
Baseline and Six Months
Title
Change in Serum LDL Cholesterol Level
Time Frame
Baseline and Six Months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen F. Binder, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

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