Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Condition: Physical Frailty; Hip Fracture; Elective Hip Replacement; Hypogonadism
MeSH terms: Hypogonadism; Frailty; Hip Fractures
Intervention: Transdermal Testosterone gel (1%); Supervised exercise training
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.; 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.
Intervention MeSH terms: Testosterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: Male
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Testosterone Replacement Therapy; Physical Frailty; Hip Fracture

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.
    

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