Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037999
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2002-05-24
Brief Title:
The Effect of Testosterone Supplementation on Rehabilitation Outcomes
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
The Effect of Testosterone Supplementation on Rehabilitation Outcomes
Status:
COMPLETED
Status Verified Date:
2002-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this project is to determine the safety and efficacy of testosterone supplementation as an adjunct to traditional rehabilitation therapy in the care of deconditioned older men Our long range goal is to determine whether other hormones eg combined testosterone and growth hormone are helpful as an adjunct to traditional rehabilitation therapy
This project is important to the VA health care system because 38 of American veterans are aged age 65 years bioavailable testosterone is diminished in older age men low testosterone is associated with impaired muscle strength and lack of muscle strength hinders rehabilitation Older men who are not successfully rehabilitated often get admitted to nursing homes for long term care at a cost of approximately 40000year Payment for long term care is currently one of our most difficult health care problems If testosterone supplementation improves rehabilitation outcomes as our pilot data suggest it will patients will be more satisfied and long-term care financial resources will be saved
We will conduct a randomized placebo-controlled trial to test the hypothesis that supplementation with testosterone improves rehabilitation outcomes in deconditioned older men Specifically we will screen all hospitalized older men with delayed discharge from the hospital 7 day hospital stay Men who have at least one new impairment in their ability to perform activities of daily living eg inability to walk low serum testosterone concentration and no contraindications eg prostate or breast cancer will be offered the opportunity to participate Study participants will be randomized to receive either testosterone 5 mg transdermally each night or placebo matching transdermal patch daily in a double-blind fashion for the duration of their hospital course expected average duration of study is 29 days Subjects will then receive their rehabilitation as usual with all members of the health care team blinded as to whether the subject is receiving testosterone or placebo At baseline weekly at discharge and at 6 and 12 months after discharge subjects will be assessed using validated measures ie Functional Independence Measure - FIM Our hypothesis is that testosterone supplementation as an adjunct to traditional rehabilitation therapy will improve rehabilitation outcomes
This project is important to the VA health care system because 38 of American veterans are aged age 65 years bioavailable testosterone is diminished in older age men low testosterone is associated with impaired muscle strength and lack of muscle strength hinders rehabilitation Older men who are not successfully rehabilitated often get admitted to nursing homes for long term care at a cost of approximately 40000year Payment for long term care is currently one of our most difficult health care problems If testosterone supplementation improves rehabilitation outcomes as our pilot data suggest it will patients will be more satisfied and long-term care financial resources will be saved
We will conduct a randomized placebo-controlled trial to test the hypothesis that supplementation with testosterone improves rehabilitation outcomes in deconditioned older men Specifically we will screen all hospitalized older men with delayed discharge from the hospital 7 day hospital stay Men who have at least one new impairment in their ability to perform activities of daily living eg inability to walk low serum testosterone concentration and no contraindications eg prostate or breast cancer will be offered the opportunity to participate Study participants will be randomized to receive either testosterone 5 mg transdermally each night or placebo matching transdermal patch daily in a double-blind fashion for the duration of their hospital course expected average duration of study is 29 days Subjects will then receive their rehabilitation as usual with all members of the health care team blinded as to whether the subject is receiving testosterone or placebo At baseline weekly at discharge and at 6 and 12 months after discharge subjects will be assessed using validated measures ie Functional Independence Measure - FIM Our hypothesis is that testosterone supplementation as an adjunct to traditional rehabilitation therapy will improve rehabilitation outcomes
Detailed Description:
Our overall goal is to determine the safety and efficacy of testosterone supplementation as an adjunct to traditional rehabilitation therapy on health outcomes in deconditioned older men Specifically we will conduct a randomized placebo-controlled trial to test the hypothesis that supplementation with testosterone improves rehabilitation outcomes in deconditioned older men We will use objective validated measures ie FIM muscle strength to assess health outcomes
We will begin enrolling subjects within three months of receipt of funding and study 60 subjects 30 in each group within 24 months All subjects will undergo follow-up evaluation 6 and 12 months after completion of inpatient rehabilitation and cessation of testosterone supplementation Therefore this project will be completed within 3 years Our short term goal within 3 years is to delineate the safety and efficacy of testosterone supplementation on rehabilitation outcomes in deconditioned older men Our long range goal is to determine whether other hormones eg combined testosterone and growth hormone are helpful as an adjunct to traditional rehabilitation therapy in the care of older men
We will begin enrolling subjects within three months of receipt of funding and study 60 subjects 30 in each group within 24 months All subjects will undergo follow-up evaluation 6 and 12 months after completion of inpatient rehabilitation and cessation of testosterone supplementation Therefore this project will be completed within 3 years Our short term goal within 3 years is to delineate the safety and efficacy of testosterone supplementation on rehabilitation outcomes in deconditioned older men Our long range goal is to determine whether other hormones eg combined testosterone and growth hormone are helpful as an adjunct to traditional rehabilitation therapy in the care of older men
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None