Physical FrailtyPhase 3NCT00345969
Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
A Phase 3 study testing Transdermal Testosterone gel (1%) and Supervised exercise training in people with Physical Frailty and Hip Fracture, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Physical Frailty, Hip Fracture, Elective Hip Replacement
- What is being tested?
- Transdermal Testosterone gel (1%) and Supervised exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Aug 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Male, age 65 years and older
- Total serum testosterone level < 350 ng/dl
- Total Modified Physical Performance Test Score <28
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Conditions
- Physical Frailty, Hip Fracture, Elective Hip Replacement, Hypogonadism
- Being tested
- Transdermal Testosterone gel (1%), Supervised exercise training
- Keywords
- Testosterone Replacement Therapy, Physical Frailty, Hip Fracture
- Medical subject headings
- Hip Fractures, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal Testosterone gel (1%)Drug
Also called Androgel
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.
Supervised exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Transdermal Testosterone gel (1%) | Active comparator | 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. Receives: Drug: Transdermal Testosterone gel (1%); Behavioral: Supervised exercise training |
| Placebo gel | Placebo comparator | 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. Receives: Behavioral: Supervised exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Total Lean Body Mass
Total Lean Mass measured by Dual X-ray Absorptiometry (DXA)
Measured: Baseline and Six Months
Change in Skeletal Muscle Strength by 1-RM
One-repetition maximum strength for leg extension
Measured: Baseline and Six Months
Secondary outcomes (6)
Change in Isokinetic Leg Extension Torque at 0 Deg/Sec
Leg Extension Torque measured with Cybex dynamometer at 0 deg/sec
Measured: Baseline and Six Months
Change in Leg Extension Torque at 60 Deg/Sec
Leg Extension Torque measured with Cybex dynamometry at 60 deg/sec
Measured: Baseline and Six Months
Change in Total Body Fat Mass
Total Body Fat Mass as measured by DXA
Measured: Baseline and Six Months
Change in Femoral Bone Mineral Density (BMD)
Femoral Bone Mineral Density measured with Dual X-ray Absorptiometry (DXA)
Measured: Baseline and Six Months
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.
Measured: Baseline and Six Months
Change in Serum Testosterone Level
Total Serum Testosterone Level (ng/mL)
Measured: Baseline and Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study startNov 2004
- Primary completionFeb 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Physical FrailtyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Responsible party
- Principal investigator, Ellen F. Binder, MD, Washington University School of Medicine
- Investigators
- Ellen F. Binder, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345969
- Sponsor's protocol ID
- HSC 02-1108
- Status last verified
- Jan 2018
- First submitted
- 27 Jun 2006
- Last updated
- 22 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
- ClinicalTrials.gov ID
- NCT00345969
- Acronym / sponsor ID
- HSC 02-1108
- Conditions
- Physical Frailty, Hip Fracture, Elective Hip Replacement, Hypogonadism
- Keywords
- Testosterone Replacement Therapy, Physical Frailty, Hip Fracture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Study start
- Nov 2004
- Primary completion
- Feb 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 29 Jun 2006 (estimated)
- Results
- Posted 22 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdermal Testosterone gel (1%) | Active comparator | Drug: Transdermal Testosterone gel (1%), Behavioral: Supervised exercise trainingTransdermal 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. |
| Placebo gel | Placebo comparator | Behavioral: Supervised exercise trainingInactive 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Male, age 65 years and older
- Total serum testosterone level < 350 ng/dl
- Total Modified Physical Performance Test Score <28
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal Testosterone gel (1%)Also: AndrogelTransdermal 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. | Drug | Transdermal Testosterone gel (1%) |
| Supervised exercise trainingSupervised 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. | Behavioural | Placebo gel, Transdermal Testosterone gel (1%) |
Primary outcome
Mean Change in Total Lean Body Mass
Time frame: Baseline and Six Months
Total Lean Mass measured by Dual X-ray Absorptiometry (DXA)
Change in Skeletal Muscle Strength by 1-RM
Time frame: Baseline and Six Months
One-repetition maximum strength for leg extension
6 secondary outcomes
Change in Isokinetic Leg Extension Torque at 0 Deg/Sec
Time frame: Baseline and Six Months
Change in Leg Extension Torque at 60 Deg/Sec
Time frame: Baseline and Six Months
Change in Total Body Fat Mass
Time frame: Baseline and Six Months
Change in Femoral Bone Mineral Density (BMD)
Time frame: Baseline and Six Months
Change in Total Modified Physical Performance (mPPT) Score
Time frame: Baseline and Six Months
Change in Serum Testosterone Level
Time frame: Baseline and Six Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen F. Binder, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transdermal Testosterone gel (1%) and Supervised exercise training in people with Physical Frailty and Hip Fracture, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Total Lean Body Mass (time frame: Baseline and Six Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018; AzTrials last refreshed its copy on 31 Oct 2026.