Effects of testosterone on muscle strength, physical function, body composition, and quality of life in intermediate-frail and frail elderly men: a randomized, double-blind, placebo-controlled study.
BACKGROUND
Physical frailty is associated with reduced muscle strength, impaired physical function, and quality of life. Testosterone (T) increases muscle mass and strength in hypogonadal patients. It is unclear whether T has similar effects in intermediate-frail and frail elderly men with low to borderline-low T.


OBJECTIVE
Our objective was to determine the effects of 6 months T treatment in intermediate-frail and frail elderly men, on muscle mass and strength, physical function, and quality of life.


METHODS
We conducted a randomized, double-blind, placebo-controlled, parallel-group, single-center study.


METHODS
PARTICIPANTS were community-dwelling intermediate-frail and frail elderly men at least 65 yr of age with a total T at or below 12 nmol/liter or free T at or below 250 pmol/liter.


METHODS
Two hundred seventy-four participants were randomized to transdermal T (50 mg/d) or placebo gel for 6 months. Outcome measures included muscle strength, lean and fat mass, physical function, and self-reported quality of life.


RESULTS
Isometric knee extension peak torque improved in the T group (vs. placebo at 6 months), adjusted difference was 8.6 (95% confidence interval, 1.3-16.0; P = 0.02) Newton-meters. Lean body mass increased and fat mass decreased significantly in the T group by 1.08 +/- 1.8 and 0.9 +/- 1.6 kg, respectively. Physical function improved among older and frailer men. Somatic and sexual symptom scores decreased with T treatment; adjusted difference was -1.2 (-2.4 to -0.04) and -1.3 (-2.5 to -0.2), respectively.


CONCLUSIONS
T treatment in intermediate-frail and frail elderly men with low to borderline-low T for 6 months may prevent age-associated loss of lower limb muscle strength and improve body composition, quality of life, and physical function. Further investigations are warranted to extend these results.
Srinivas-Shankar
Upendram
U
Andrology Research Unit, Department of Medicine and Endocrinology, University of Manchester, Manchester Royal Infirmary, Grafton Street, Manchester, United Kingdom M13 9WL.
Roberts
Stephen A
SA
Connolly
Martin J
MJ
O'Connell
Matthew D L
MD
Adams
Judith E
JE
Oldham
Jackie A
JA
Wu
Frederick C W
FC
D000368:Aged; D001823:Body Composition / Q000187:drug effects*; D004311:Double-Blind Method; D016330:Frail Elderly; D005684:Gait / Q000187:drug effects; D006801:Humans; D008297:Male; D009043:Motor Activity / Q000187:drug effects*; D053580:Muscle Strength / Q000187:drug effects*; D004856:Postural Balance / Q000187:drug effects; D011788:Quality of Life; D013739:Testosterone / Q000009:adverse effects / Q000097:blood / Q000494:pharmacology*
D013739:Testosterone