Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2009 Mar;30(2):133-40.
doi: 10.1016/j.cct.2008.10.005. Epub 2008 Oct 29.

Effects of testosterone therapy on muscle performance and physical function in older men with mobility limitations (The TOM Trial): design and methods

Nathan K LeBrasseur  1 , Newsha Lajevardi, Renee Miciek, Norman Mazer, Thomas W Storer, Shalender Bhasin
Affiliations
Randomized Controlled Trial

Effects of testosterone therapy on muscle performance and physical function in older men with mobility limitations (The TOM Trial): design and methods

Nathan K LeBrasseur et al. Contemp Clin Trials. 2009 Mar.

Abstract

The TOM study is the first, single-site, placebo-controlled, randomized clinical trial designed to comprehensively determine the effects of testosterone administration on muscle strength and physical function in older men with mobility limitations. A total of 252 community dwelling individuals aged 65 and older with low testosterone levels and self-reported limitations in mobility and short physical performance battery (SPPB) scores between 4 and 9 will be randomized to receive either placebo or testosterone therapy for 6 months. The primary objective is to determine whether testosterone therapy improves maximal voluntary muscle strength as quantified by the one repetition maximum. Secondary outcomes will include measures of physical function (walking, stair climbing and a lifting and lowering task), habitual physical activity and self-reported disability. The effects of testosterone on affect, fatigue and sense of well being will also be assessed. Unique aspects of the TOM Trial include selection of men with self-reported as well as objectively demonstrable functional limitations, community-based screening and recruitment, adjustment of testosterone dose to ensure serum testosterone levels in the target range while maintaining blinding, and inclusion of a range of self-reported and performance-based physical function measures as outcomes. Clinicaltrials.gov identifier: NCT00240981.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Jette AM, Pinsky JL, Branch LG, Wolf PA, Feinleib M. The Framingham Disability Study: physical disability among community-dwelling survivors of stroke. J Clin Epidemiol. 1988;41(8):719–726. - PubMed
    1. Tinetti ME, Speechley M, Ginter SF. Risk factors for falls among elderly persons living in the community. N Engl J Med. 1988;319(26):1701–1707. - PubMed
    1. Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med. 1995;332(9):556–561. - PMC - PubMed
    1. Studenski S, Perera S, Wallace D, et al. Physical performance measures in the clinical setting. J Am Geriatr Soc. 2003;51(3):314–322. - PubMed
    1. Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. Jama. 1995;273(1):59–65. - PubMed

Publication types

MeSH terms

Associated data