Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
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| ClinicalTrials.gov Identifier: NCT00345969 |
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Recruitment Status :
Completed
First Posted : June 29, 2006
Results First Posted : February 22, 2018
Last Update Posted : February 22, 2018
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Sponsor:
Washington University School of Medicine
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Ellen F. Binder, MD, Washington University School of Medicine
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Conditions |
Physical Frailty Hip Fracture Elective Hip Replacement Hypogonadism |
| Interventions |
Drug: Transdermal Testosterone gel (1%) Behavioral: Supervised exercise training |
| Enrollment | 25 |
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 Details | 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 | |
|---|---|---|---|---|
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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 Number of Baseline Participants | 11 | 11 | 22 | |
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Baseline Analysis Population Description |
Men who completed the intervention and provided baseline and follow-up data for primary outcome measures.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 11 participants | 11 participants | 22 participants | |
| 81 (4) | 77 (6) | 80 (7) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 11 participants | 11 participants | 22 participants | |
| Female |
0 0.0%
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0 0.0%
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0 0.0%
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| Male |
11 100.0%
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11 100.0%
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22 100.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 11 participants | 11 participants | 22 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
0 0.0%
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0 0.0%
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0 0.0%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
0 0.0%
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2 18.2%
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2 9.1%
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| White |
11 100.0%
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9 81.8%
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20 90.9%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Total Modified Physical Performance (mPPT) score
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 11 participants | 11 participants | 22 participants | |
| 23 (4) | 26 (3) | 25 (4) | ||
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[1]
Measure Description: Range 0-36, (min-max); higher scores indicate better physical performance. The Total mPPT score is constructed by summing sub-scores of 9 performance tasks. Sub-scores have a range of 0-4 (min-max); higher sub-scores indicate better performance.
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Total Testosterone level (ng/dL)
Mean (Standard Deviation) Unit of measure: ng/dL |
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| Number Analyzed | 11 participants | 11 participants | 22 participants | |
| 252 (71) | 248 (97) | 250 (84) | ||
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BMI (kg/m2)
Mean (Standard Deviation) Unit of measure: Kg/m2 |
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| Number Analyzed | 11 participants | 11 participants | 22 participants | |
| 28 (3) | 29 (5) | 29 (4) | ||
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Body Weight (lbs.)
Mean (Standard Deviation) Unit of measure: Lbs. |
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| Number Analyzed | 11 participants | 11 participants | 22 participants | |
| 193 (30) | 195 (38) | 194 (34) | ||
Outcome Measures
Adverse Events
Limitations and 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
Results Point of Contact
| Name/Title: | Ellen F. Binder, MD |
| Organization: | Washington University School of Medicine |
| Phone: | 314-286-2707 |
| EMail: | ebinder@wustl.edu |
| Responsible Party: | Ellen F. Binder, MD, Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00345969 |
| Other Study ID Numbers: |
HSC 02-1108 |
| First Submitted: | June 27, 2006 |
| First Posted: | June 29, 2006 |
| Results First Submitted: | January 15, 2016 |
| Results First Posted: | February 22, 2018 |
| Last Update Posted: | February 22, 2018 |