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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 NIA followed the IOM’s recommendations and funded The Testosterone Trials (The TTrials) to determine the efficacy of testosterone treatment in older men with age-related decline in testosterone levels and one or more symptoms or signs of testosterone deficiency. The IOM committee concluded that there was insufficient evidence that testosterone treatment of older men with low testosterone was beneficial and recommended that the NIA fund a coordinated set of efficacy trials to determine if this treatment has any benefits and to fund a larger trial to determine possible risks only if benefits were found. We aimed to raise testosterone levels into the mid-range for healthy men; it is possible that higher on-treatment testosterone levels could result in greater gains in 6MWD. Some of the improvements in 6MWD could be due to the testosterone-induced increase in hemoglobin, but additional direct effects of testosterone on the muscle mitochondrial function and bioenergetics, and aerobic performance could also contribute to the improvement in 6MWD. We aimed to raise testosterone levels into the mid-range for healthy men; it is possible that higher on-treatment testosterone levels could result in greater gains in 6MWD.The number of men reporting falls or seeking medical attention for fall-related injuries during the year on treatment was similar in each treatment group.
The PFT is the first to evaluate the effects of testosterone replacement on falls. This report also describes testosterone’s effects on fall frequency, which had not been studied previously. This manuscript describes in detail the results of the Physical Function Trial (PFT), which was one of the three primary trials. The TTrials included a set of 7 coordinated trials – 3 primary and 4 secondary trials.
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.
Some individuals may notice positive changes within a few weeks, while others may take several months. The timeframe for experiencing improvements in joint health and mobility with TRT can vary from person to person. While TRT can be beneficial for joint health, it is essential to consider potential risks and side effects. This can alleviate joint pain, stiffness, and enhance overall mobility. Without sufficient testosterone, cartilage may become less effective in cushioning the joints, leading to discomfort and limited range of motion.
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.
Men reporting mobility limitation showed significantly more improvement in 6MWD and in PF10 than placebo-treated men. As with many aspects of hypermobility management, it can take trial and error, and support from a relevant health care professional to find the right approach for each individual. Studies on female athletes have indicated that the increased risk of injury may be due to a combination of changes in joint laxity, and changes in coordination and muscle control. Oestrogen and testosterone both help to maintain bone density and strength. Oestrogen, progestogen, relaxin and testosterone all impact the body in ways that are relevant to hypermobility.
The change in PF10 from baseline in men treated with testosterone was not significantly related to the change in total and free testosterone, DHT and estradiol level (data not shown). Serum free testosterone, DHT and estradiol concentrations also increased in the testosterone group, but did not change in the placebo group. The men enrolled in the PFT were on average older, had higher BMI, were more likely to have comorbid conditions, and, as expected, had slower gait speed and lower PF10 score than those not enrolled in this trial. The two intervention groups were similar in their baseline characteristics among men enrolled and not enrolled in the PFT (Table 1), among men whose baseline gait speed was Supplementary tables 1 and 2). Among the 390 men who were enrolled in the PFT, 35 withdrew prior to month 12, 13 in the testosterone group and 22 in the placebo group (CONSORT diagram; Figure 1). As described (19), among 790 men who were enrolled in the TTrials, 390 were enrolled in the PFT; 193 men were allocated to the testosterone arm and 197 to the placebo arm. - https://www.cives.pl/monserrateccy6
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