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In addition to optimizing the methods to detect change in the primary and secondary outcome measures, another distinction of the TOM study is the administration and tailoring of the testosterone dose to restore circulating levels to the mid-normal range. Measures of muscle performance and physical function will also be performed at the study midpoint (3 months) and at the end of the 6-month treatment period. This is a single-site, placebo-controlled, randomized clinical trial that will enroll a total of 252 community dwelling older men aged 65 and older who have low total (less than 350 ng/dL by liquid chromatography tandem mass spectrometry, LC-MS/MS) or free testosterone (less than 50 pg/mL) levels and who self-report and demonstrate limitations in physical mobility.
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.
The PF-10 scores improved significantly more in men treated with testosterone than in men treated with placebo among men whose baseline 6MWS was ≥1.2 m/sec (treatment effect 4.9, 95% CI (2.2, 7.7) PFigure 3). Adherence to assigned treatment in men enrolled in the PFT, assessed by weighing the returned bottles and comparing it to the expected weight based on the prescribed dose, was high in both the testosterone and placebo groups (means 97% and 92%), respectively, with fewer than 5% of men with compliance135%). The primary analysis was performed using random effects models for longitudinal data, which included visit time as a categorical variable and a single main effect for treatment, and included balancing factors and baseline value of the 6-minute walking distance as fixed effect covariates. Our expectation was that men who walked more slowly and perceived mobility problems would be more likely to benefit from testosterone treatment than men who were functioning at a higher level.
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.
This is because the lack of testosterone can result in the thinning of cartilage, the protective tissue that covers the ends of bones in a joint. Testosterone plays a crucial role in maintaining joint health and mobility. One area that can be significantly impacted is joint health and mobility. The authors thank Dr. Wildon Farwell and colleagues at the VA Boston Healthcare System for their efforts to establish the VA investigational site for this study. Collectively, these steps reflect a committed effort to ensuring the health and safety of study participants. There is significant controversy with respect to the safety of testosterone administration in older individuals. We acknowledge that age-related limitations in mobility are complex and multifactorial.
In preliminary studies, these measures were safe, well-tolerated and demonstrated excellent reliability in older individuals . The 1RM measure will be administered in accordance with a standardized testing protocol designed to minimize the confounding influence of learning and familiarization effects, provide adequate warm-up, prevent injury and minimize fatigue in order to optimize performance. Thus, we plan to optimize recruitment efficiency by implementing the described multi-faceted and -phased community-based recruitment strategies including on-site community—based screening, fostering a relationship with the local VA hospital, and direct mailings to local residents in the study demographic based on census tract data. Interactions between the treatment groups and these covariates may also be incorporated into the model where clinically justified. Based on these estimates and allowing for a 20% drop out rate in a 6 month time period, we propose to enroll 126 men in each treatment group for a total of 252 participants. Testosterone gel is an FDA-approved product that has undergone phase I, II, and III studies for the treatment of hypogonadal men 42, 43.
Testosterone consistently improved self-reported walking ability, modestly improved 6MWD in all men participating in the Testosterone Trials, but did not affect falls. However, there needs to be consideration for the potential that hormones which we introduce to the body (e.g. contraception and HRT) may worsen hypermobility symptoms. The symptoms listed in bold are also often caused by or linked to hypermobility, and the combination of the two causes can amplify the severity of the symptoms. The hormonal changes that happen at puberty, during the menstrual cycle, perimenopause and menopause, or with various other conditions such as polycystic ovarian syndrome or endometriosis, can cause a wide range of symptoms. Given that hypermobile people already have lax joints and rely on muscle control to help stabilise those joints, it is not surprising that this effect can be amplified in some hypermobile people. There are questions about the impact of synthetic oestrogens as well, for example, in the combined pill with research showing that they may impact joint stability, particularly in  individuals with hypermobility.
Testosterone plays a key role in muscle mass and connective tissue strength. The locomotive system includes support (bones), mobility and impact absorption (joints and intervertebral disks), drive and control (muscles, nerves), and network (blood vessels). Testosterone replacement therapy (TRT) can have several positive effects on joint health and mobility. Additionally, testosterone aids in the maintenance of bone density, which is essential for joint stability and strength. In recognition of these concerns the TOM study will incorporate several measures to minimize the risks to the participant. Measures of physical function are now the principal outcomes to gauge the efficacy of potential anabolic therapies because of their strong predictive ability for hospitalization , disability and even mortality 6, 7. The DSMB will convene every 6 months and is empowered to discontinue treatment in one or more subjects or halt the study should the occurrence of adverse events so warrant.
This should prompt a closer look at how hormonal factors can influence symptoms and quality of life for those affected by hypermobility. There is an increasing recognition of hypermobility-related disorders in the UK and a rise in use of hormone replacement therapy for perimenopausal symptoms. Recent research suggests that hormone fluctuations can play a role in variability of hypermobility related symptoms, especially for women. The purpose of this review is to investigate the role of testosterone in each of the systems involved in the locomotive syndrome. The new gameplan for max muscle now—and the rest of your life.

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