Frailty, Sarcopenia
Conditions
Keywords
Frailty, Muscle strength, Physical performance, Bone mineral density, Quality of life
Brief summary
The study aims to determine the effects of testosterone on muscle function, mobility, activities of daily living and overall quality of life
Detailed description
Ageing-associated loss of muscle mass and strength is a major cause of physical frailty, disability, morbidity and dependency in the elderly. This is associated with increased falls, fractures, loss of mobility, restricted activities of daily living and increased utilisation of healthcare resources. It is well known that serum testosterone levels fall with advancing age and this may be an important cause for muscle wasting and weakness (sarcopenia). Testosterone replacement increases muscle mass and improves muscle strength in young hypogonadal men. In relatively healthy elderly men, some short-term studies have also shown that testosterone can improve muscle strength. The potential beneficial effects of testosterone supplementation on muscle strength and functional capacity of frail elderly men has so far not been studies and forms the basis of this research. We hypothesise that testosterone supplementation is an effective, safe and economic anabolic intervention in frail elderly men with low circulating testosterone.
Interventions
DRUGTransdermal testosterone gel (Testogel 1% )
Transdermal testosterone gel (Testogel 1% ), 50 mg/d for 6 months
DRUGMatched transdermal placebo gel
Matched transdermal placebo gel, 50mg/d for 6 months
Sponsors
University of Manchester
Bayer
Manchester University NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Frail elderly men (as defined by Freid's criteria of frailty) * Community - dwelling men aged 65 years and above * Total testosterone ≤12.0 nmol/L or calculated free T≤0.25nmol/L
Exclusion criteria
* Carcinoma of prostate * Carcinoma of breast * PSA \>4ng/mL * Severe symptomatic benign prostatic hypertrophy (IPSS \>21) * Active liver disease * Renal impairment (serum creatinine \>180 mmol/L) * Congestive heart failure * Unstable ischaemic heart disease * Polycythaemia * Evidence of systemic disease which may affect muscle/joint function * Moderate to severe peripheral vascular disease * Moderate to severe chronic obstructive airways disease * Alcohol consumption over 30 units per week * Medications that interfere with sex steroid metabolism * History of stroke causing persistent motor deficit * Cognitive deficit * Major psychiatric illness * Hospital admission in the past 6 weeks * Sleep apnoea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lower limb muscle strength at 6 months | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Upper limb muscle strength at 6 months | 6 months |
| Quality of life at 6 months | 6 months |
| Total and regional lean body mass at 6 months | 6 months |
| Improvement in physical performance | 6 months |
| Bone Mineral Density | 6 months |
Countries
United Kingdom
Outcome results
None listed