At a glance
ClinicalIndex Comparison Record- ✓Male age 65 years or older
- ✓Total serum testosterone <350 ng/dL
- ✓Modified Physical Performance Test Score <28 (physical frailty)
- ✕Unable to walk 50 feet independently
- ✕Current use of estrogen, progestin, or androgen-containing compounds
- ✕Dementia interfering with consent/compliance or Short Blessed Test ≥11
- ✕Visual or hearing impairments interfering with following directions
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
In Brief
A Phase 3 clinical trial evaluating Transdermal Testosterone gel (1%) and Supervised exercise training for Physical Frailty and 3 related conditions. Completed, enrolled 25 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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 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.