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A fundamental shortcoming of two recent trials that studied the effects of testosterone replacement on aspects of strength, physical function and mobility in older men with low testosterone levels was the failure to induce appreciable changes in circulating levels of testosterone 32, 33. 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. This has been neglected in the design of similar and recent studies that failed to induce meaningful changes in testosterone levels and not surprisingly, reported no improvements in muscle strength or physical function and mobility 32, 33. The Testosterone Trials (The TTrials) were a set of seven coordinated placebo-controlled trials, designed to determine the efficacy of testosterone in improving sexual function, physical function, vitality, and other outcomes in older men with unequivocally low testosterone levels and low libido, mobility limitation and/or low vitality (17–19). We report detailed results of The Physical Function Trial (PFT), one of seven Testosterone Trials (TTrials), which determined testosterone’s effects on mobility, self-reported physical function, falls, and patient global impression-of-change (PGIC) in older men with self-reported mobility limitation and walking speed
The PFT is the largest controlled trial of testosterone’s effects on physical function and mobility in older men. It is possible that functional exercise training may augment the translation of testosterone-induced muscle mass and strength gains into functional improvements, as exercise training has been reported to augment the anabolic effects of testosterone (30). TTrials is one of the largest testosterone trials to be conducted to-date which enrolled older men with unequivocally low testosterone levels, measured using liquid chromatography tandem mass spectrometry assay certified by the Center for Disease Control’s Hormone Standardization Program for Testosterone (HoST). The improvement in self-reported mobility and function, measured by the PF-10 and the PGIC, was observed in all men treated with testosterone, regardless of the baseline walk speed, although the specific effect on 6MWD was greater in men with higher gait speed. Comparison of change in 6-minute walking distance and PF10 scores in men enrolled in the Physical Function Trial and men not enrolled in the physical function trial.
We have selected muscle strength of the lower extremities as our primary outcome measure for sample size determination because of its marked decline with advancing age and its critical importance for physical function and mobility (climbing stairs, getting up from a chair, maintaining balance and avoiding falls). Thus, strategies to augment muscle mass may confer improvements upon physical function and mobility by improving muscle strength and power. Secondary outcomes will include measures of physical function (walking, stair climbing and a lifting and lowering task), habitual physical activity and self-reported disability. Because both self-reported as well as performance-based measures of physical function have some assets and some inherent limitations, the TTrials included both categories of outcomes to enable a more comprehensive assessment of physical function and mobility than had been conducted before. Although lean body mass and muscle strength were not measured in this trial, testosterone administration has been shown consistently in numerous trials to increase skeletal muscle mass and maximal voluntary strength (1–11, 15–16). Further studies of longer duration are needed to determine the clinical meaningfulness of testosterone’s effects, using patient-important outcomes that are more closely aligned with testosterone-induced gains in muscle mass and strength, such as stair climbing speed and chair stand.
Accordingly, we compared the changes in 6MWD and PF10 in men whose baseline gait speed was All randomized participants with any follow-up data were analyzed in the group to which they were allocated regardless of their compliance (intention-to-treat). The association of PGIC with other outcomes was assessed in a mixed effects model for longitudinal data, considering PGIC as a time-varying covariate and including treatment arm, balancing factors and baseline value of the outcome in the model. These analyses were performed using marginal models with parameters estimated using generalized estimating equations (GEE), including balancing variables and change from baseline of hormone levels at each measured time point as time-varying covariates and baseline value of the hormones and the 6MWD. For logistic models of binary outcomes, the treatment effect was the log odds ratio of a positive versus negative outcome for testosterone versus placebo participants, averaged over all visits. At the completion of the trial, serum testosterone, dihydrotestosterone, and estradiol levels were measured using LC-MS/MS and free testosterone using equilibrium dialysis in the Brigham Research Assay Core Laboratory, as described (19). PF10 was selected as the self-reported measure of mobility because this instrument includes a number of questions about difficulty in walking short as well as long distances. The 6MWD, a widely used measure of mobility, was selected as the primary outcome because walking is essential for most activities of daily living; walking speed and distance predict clinical outcomes including disability and mortality (22–24); and estimates of the minimum clinically important difference (MCID) (50 meters) were available (25–27).
Relaxin affects the cardiovascular system during pregnancy to allow stability in the change to hyperdynamic circulation. Testosterone affects blood vessel tone and heart function and plays a role in red blood cell production. Table 1 below shows the impact of these hormones on the body, detailing how the effect of hormones extends beyond the reproductive system (this list could be expanded on but gives an overview of hormonal effects). For women, there are generally more occasions for hormonal change and more hormones to consider. For most men the hormone that is most impactful is testosterone.
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