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Indeed, some trials have reported improvements in stair climbing power with testosterone administration (8, 14). The 6MWS continued to improve throughout the intervention duration and we do not know whether a longer duration of intervention may have enabled the neuromuscular adaptations needed to translate testosterone-induced muscle mass and strength gains into clinically meaningful functional improvements. Taken together, these findings suggest a likely small benefit of testosterone on mobility in older men with low testosterone levels.
The observation that testosterone administration increases skeletal muscle mass and maximal voluntary muscle strength (1–9) has led to considerable pharmaceutical interest in applying testosterone as an anabolic therapy to improve physical function and to reduce the burden of disability in older men with mobility limitation. In this initial trial, we are confident that testosterone therapy will increase muscle mass and strength (primary outcome) and propose that this will translate into improvements in physical function (secondary outcomes). In contrast to recent trials of replacement therapy in older men that achieved only marginal increases in testosterone levels, this study aims to restore testosterone to the mid- to high-normal range. Subjects will perform laboratory-based measures of muscle performance, physical function and physical activity at baseline and following 3 and 6 months of treatment. The secondary aim of this study is to test whether testosterone administration mediates improvements in self-reported as well as performance-based measures of physical function, self-reported disability and habitual physical activity. 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) score between 4 and 9 will be randomized to receive either placebo or testosterone therapy for 6 months. Unlike previous trials, which often used surrogate endpoints such as lean body mass and muscle performance measures, the TTrials included physical function outcomes that were deemed patient-important and of public health significance.
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.
Physical examinations including prostate digital examination, and AUA/IPSS symptom score will be obtained at baseline and during months 3 and at the end of treatment. Additionally, the subjects will be asked about adverse events and compliance at baseline, during week 2, and every six weeks throughout the treatment period. Hemoglobin and hematocrit, PSA, and blood chemistries will be monitored at baseline, and then every six weeks throughout the treatment period and at the end of the three month recovery period. Following termination of the study intervention and completion of the outcome measures, subjects will be seen at a 3 month follow up visit for a final safety assessment.
As reported previously (19), neither the proportion of men increasing their 6MWD by more than 50 m 35 (20.4%) in the testosterone arm and 20 (12.1%) in the placebo arm, nor the absolute change from baseline in 6MWD differed significantly between the two intervention arms in men enrolled in the PFT. Among men not enrolled in the PFT, 175 had baseline gait speed less than 1.2 m/sec, and 57 reported mobility limitation. Some earlier trials were limited by their small size and suboptimal statistical power; inclusion of healthy older men without functional limitations; heterogeneity of testosterone doses, on-treatment levels, and outcomes ascertainment; and relatively short intervention durations of 3 to 6 months. However, randomized trials of testosterone have not demonstrated consistent improvements in performance-based measures of physical function in older men with functional limitations (1–16). Almost in parallel with the structure supporting mobility and body functions, testosterone levels decrease with age. Testosterone levels progressively decline into late life and therapeutic replacement augments muscle mass in older individuals; however, its effects on muscle performance and physical function have not been adequately examined.
These observations underscore the importance of the methods described here that will allow monitoring of testosterone levels during therapy and adjustment of the testosterone dose by an unblinded physician and also insure masking of other study personnel and the participants. Additional trials will need to be performed to establish meaningful improvements in physical function and other health-related outcomes. We have recently observed, however, that older subjects with self-reported and objective limitations in mobility demonstrate significantly lower muscle strength than those without . To date, studies of testosterone replacement in older men have either excluded objective measures of physical function or suffered methodological shortcomings. In comparison to previous studies of testosterone administration in older subjects who were higher functioning and community dwelling, the inclusion of individuals with mobility limitations presents a significant recruitment challenge. This study will provide a framework from which future clinical trials of anabolic function promoting therapies can be developed.
Sign up for muscle-building workouts, expert weight loss advice, and nutritious meal plans, delivered to your email daily. It’s important to consult with a healthcare professional to determine if TRT is suitable for you and to manage any potential risks or side effects. By promoting the production of synovial fluid and maintaining bone density, TRT can alleviate joint discomfort and enhance mobility. Testosterone plays a significant role in joint health and mobility for men. Adhering to the prescribed treatment plan and maintaining a healthy lifestyle, including regular exercise and a balanced diet, can help optimize the benefits of TRT for joint health.
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