Insulin resistance during androgen deprivation therapy in men with prostate cancer.

BACKGROUND: Androgen deprivation therapy (ADT) in prostate cancer (PCa) has been associated with development of insulin resistance. However, the predominant site of insulin resistance remains unclear. METHODS: The ADT & Metabolism Study was a single-center, 24-week, prospective observational study that enrolled ADT-naive men without diabetes who were starting ADT for at least 24 weeks (ADT group, n = 42). The control group comprised men without diabetes with prior history of PCa who were in remission after prostatectomy (non-ADT group, n = 23). Prevalent diabetes mellitus was excluded in both groups using all three laboratory criteria defined in the American Diabetes Association guidelines. All participants were eugonadal at enrollment. The primary outcome was to elucidate the predominant site of insulin resistance (liver or skeletal muscle). Secondary outcomes included assessments of body composition, and hepatic and intramyocellular fat. Outcomes were assessed at baseline, 12, and 24 weeks. RESULTS: At 24 weeks, there was no change in hepatic (1.2; 95% confidence interval [CI], -2.10 to 4.43; p = .47) or skeletal muscle (-3.2; 95% CI, -7.07 to 0.66; p = .10) insulin resistance in the ADT group. No increase in hepatic or intramyocellular fat deposition or worsening of glucose was seen. These changes were mirrored by those observed in the non-ADT group. Men undergoing ADT gained 3.7 kg of fat mass. CONCLUSIONS: In men with PCa and no diabetes, 24 weeks of ADT did not change insulin resistance despite adverse body composition changes. These findings should be reassuring for treating physicians and for patients who are being considered for short-term ADT.

Bone microarchitectural alterations associated with spinal cord injury: Relation to sex hormones, metabolic factors, and loading.

CONTEXT: People living with spinal cord injury (SCI) are at high risk for bone fractures. Neural, hormonal and metabolic contributors to bone microarchitectural alterations are incompletely understood. OBJECTIVE: To determine the relationship of physical, metabolic and endocrine characteristics with bone microarchitecture, characterized using high-resolution peripheral quantitative computed tomography (HRpQCT) in SCI. DESIGN: Cross-sectional analyses of bone properties in people with SCI. PARTICIPANTS: Twenty adults with SCI and paraplegia (12) or motor incomplete quadriplegia (8). OUTCOME MEASURES: Distal tibia and radius HRpQCT parameters, including density, microstructure and strength by microfinite element anaysis (µFEA); sex hormones; metabolic and inflammatory markers. RESULTS: The mean age of the participants with SCI was 41.5 ± 10.3 years, BMI 25.7 ± 6.2 kg/m2, time since injury 10.4 ± 9.0 years. Participants with SCI had significantly lower median total (Z score - 3.3), trabecular (-2.93), and cortical vBMD (-1.87), and Failure Load by µFEA (-2.48) at the tibia than controls. However, radius vBMD, aBMD and microarchitecture were similar in participants with SCI and un-injured controls. Unexpectedly, C-Reactive Protein (CRP) was positively associated with tibial trabecular vBMD (ß = 0.77, p = 0.02), thickness (ß = 0.52, p = 0.04) and number (ß = 0.92, p = 0.02). At the radius, estradiol level was positively associated with total vBMD (ß = 0.59, p = 0.01), trabecular thickness (ß = 0.43, p = 0.04), cortical thickness (ß = 0.63, p = 0.01) and cortical porosity (ß = 0.74 p = 0.04). CONCLUSIONS: Radius vBMD and microarchitecture is preserved but tibial total, cortical and trabecular vBMD, and estimated bone strength are markedly lower and bone microarchitectural parameters substantially degraded in people with SCI. The alterations in bone microarchitecture in people with SCI are likely multifactorial, however marked degradation of bone microarchitecture in tibia but not radius suggests that unloading is an important contributor of site-specific alterations of bone microarchitecture after SCI. Fracture prevention in SCI should focus on strategies to safely increase bone loading. CLINICALTRIALS: gov registration #: (NCT03576001).

Physical function endpoints in cancer cachexia clinical trials: Systematic Review 1 of the cachexia endpoints series.

In cancer cachexia trials, measures of physical function are commonly used as endpoints. For drug trials to obtain regulatory approval, efficacy in physical function endpoints may be needed alongside other measures. However, it is not clear which physical function endpoints should be used. The aim of this systematic review was to assess the frequency and diversity of physical function endpoints in cancer cachexia trials. Following a comprehensive electronic literature search of MEDLINE, Embase and Cochrane (1990-2021), records were retrieved. Eligible trials met the following criteria: adults (≥18 years), controlled design, more than 40 participants, use of a cachexia intervention for more than 14 days and use of a physical function endpoint. Physical function measures were classified as an objective measure (hand grip strength [HGS], stair climb power [SCP], timed up and go [TUG] test, 6-min walking test [6MWT] and short physical performance battery [SPPB]), clinician assessment of function (Karnofsky Performance Status [KPS] or Eastern Cooperative Oncology Group-Performance Status [ECOG-PS]) or patient-reported outcomes (physical function subscale of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaires [EORTC QLQ-C30 or C15]). Data extraction was performed using Covidence and followed PRISMA guidance (PROSPERO registration: CRD42022276710). A total of 5975 potential studies were examined and 71 were eligible. Pharmacological interventions were assessed in 38 trials (54%). Of these, 11 (29%, n = 1184) examined megestrol and 5 (13%, n = 1928) examined anamorelin; nutritional interventions were assessed in 21 trials (30%); and exercise-based interventions were assessed in 6 trials (8%). The remaining six trials (8%) assessed multimodal interventions. Among the objective measures of physical function (assessed as primary or secondary endpoints), HGS was most commonly examined (33 trials, n = 5081) and demonstrated a statistically significant finding in 12 (36%) trials (n = 2091). The 6MWT was assessed in 12 trials (n = 1074) and was statistically significant in 4 (33%) trials (n = 403), whereas SCP, TUG and SPPB were each assessed in 3 trials. KPS was more commonly assessed than the newer ECOG-PS (16 vs. 9 trials), and patient-reported EORTC QLQ-C30 physical function was reported in 25 trials. HGS is the most commonly used physical function endpoint in cancer cachexia clinical trials. However, heterogeneity in study design, populations, intervention and endpoint selection make it difficult to comment on the optimal endpoint and how to measure this. We offer several recommendations/considerations to improve the design of future clinical trials in cancer cachexia.

Nicotinamide Adenine Dinucleotide Augmentation in Overweight or Obese Middle-Aged and Older Adults: A Physiologic Study.

CONTEXT: Nicotinamide adenine dinucleotide (NAD) levels decline with aging and age-related decline in NAD has been postulated to contribute to age-related diseases. OBJECTIVE: We evaluated the safety and physiologic effects of NAD augmentation by administering its precursor, ß-nicotinamide mononucleotide (MIB-626, Metro International Biotech, Worcester, MA), in adults at risk for age-related conditions. METHODS: Thirty overweight or obese adults, ≥ 45 years, were randomized in a 2:1 ratio to 2 MIB-626 tablets each containing 500 mg of microcrystalline ß-nicotinamide mononucleotide or placebo twice daily for 28 days. Study outcomes included safety; NAD and its metabolome; body weight; liver, muscle, and intra-abdominal fat; insulin sensitivity; blood pressure; lipids; physical performance, and muscle bioenergetics. RESULTS: Adverse events were similar between groups. MIB-626 treatment substantially increased circulating concentrations of NAD and its metabolites. Body weight (difference -1.9 [-3.3, -0.5] kg, P = .008); diastolic blood pressure (difference -7.01 [-13.44, -0.59] mmHg, P = .034); total cholesterol (difference -26.89 [-44.34, -9.44] mg/dL, P = .004), low-density lipoprotein (LDL) cholesterol (-18.73 [-31.85, -5.60] mg/dL, P = .007), and nonhigh-density lipoprotein cholesterol decreased significantly more in the MIB-626 group than placebo. Changes in muscle strength, muscle fatigability, aerobic capacity, and stair-climbing power did not differ significantly between groups. Insulin sensitivity and hepatic and intra-abdominal fat did not change in either group. CONCLUSIONS: MIB-626 administration in overweight or obese, middle-aged and older adults safely increased circulating NAD levels, and significantly reduced total LDL and non-HDL cholesterol, body weight, and diastolic blood pressure. These data provide the rationale for larger trials to assess the efficacy of NAD augmentation in improving cardiometabolic outcomes in older adults.

Better Understanding Wearable Activity Monitor Use and Non-Use Among Older Adults: A Qualitative Study.

We used qualitative methods to better understand wearable activity monitor (WAM) use and its relationship with physical activity (PA) among older adults. Four focus groups, stratified by current/past ("ever") WAM users and "never" WAM users, were conducted with 57 participants aged ≥60 years. Data were coded with deductive and inductive approaches. Among ever WAM users, those with low pre-WAM PA levels reported higher PA related to WAM use while those with high pre-WAM PA levels reported they used WAM for tracking and monitoring their activity. Ever WAM users were motivated to increase PA through rewards and social support. Many never WAM users reported that WAM was unnecessary. WAM may be helpful for some older adults to increase their PA, particularly those who are motivated by setting and achieving PA goals. The results could help develop strategies to overcome barriers to WAM adoption and promote WAM use among older adults.

Testosterone replacement in prostate cancer survivors with testosterone deficiency: Study protocol of a randomized controlled trial.

BACKGROUND: Most men diagnosed with prostate cancer today have organ-confined disease and low risk of disease recurrence after radical prostatectomy. Testosterone deficiency in prostate cancer survivors contributes to impaired health-related quality of life but testosterone treatment is viewed as a contraindication in this population. OBJECTIVES: We describe the design of the first randomized trial to determine the safety and efficacy of testosterone treatment in men who have undergone prostatectomy for non-aggressive prostate cancer and have symptomatic testosterone deficiency. METHODS: Surviving Prostate cancer while Improving quality of life through Rehabilitation with Testosterone Trial is a randomized, placebo-controlled, double-blind, parallel group trial in 142 men, ≥ 40 years, who have undergone radical prostatectomy for organ-confined prostate cancer, Gleason score ≤ 7 (3+4), Stage pT2, N0, M0 lesions and have symptomatic testosterone deficiency and undetectable prostate specific antigen for > 2 years after surgery. Eligible participants are randomized to weekly intramuscular injections of 100-mg testosterone cypionate or placebo for 12 weeks and followed for another 12 weeks. Primary endpoint is change from baseline in sexual activity. Secondary outcomes include change in sexual desire, erectile function, energy, lean and fat mass, physical and cognitive performance. Safety is assessed by monitoring prostate-specific antigen, lower urinary tract symptoms, hemoglobin, and adverse events. RESULTS: The trial is being conducted at two trial sites in Boston, MA and Baltimore, MD. As of July 30, 2022, 42 participants have been randomized. No prostate-specific antigen or clinical recurrence has been noted to-date. DISCUSSION: Recruitment was slowed by coronavirus disease 2019-related closures, slow subsequent ramp-up of research activities, and patient concerns about safety of testosterone treatment. Despite these challenges, participant retention has been high. CONCLUSION: The Surviving Prostate cancer while Improving quality of life through Rehabilitation with Testosterone Trial, a placebo-controlled, randomized trial, will determine whether testosterone replacement therapy is safe and efficacious in correcting symptoms of testosterone deficiency in prostate cancer survivors, and potentially inform clinical practice.

Tai Chi and Qigong for trauma exposed populations: A systematic review.

Background: Trauma exposure and posttraumatic stress are highly prevalent and comorbid with health problems. Despite the apparent systemic nature of post-traumatic stress, recommended treatments neglect trauma's deleterious effects on health. Integrative mind-body treatments for posttraumatic stress, such as Tai Chi and Qigong (TCQ), may offer a promising adjunct to first-line treatments. Method: A systematic search was conducted to identify trials that examined Tai Chi and/or Qigong as treatments for trauma-exposed populations. Studies were examined for rigor; design, sample and intervention characteristics, dropout, attendance, satisfaction, acceptability, and key findings were systematically extracted. Results: The 6 studies included are all pilot or feasibility trials with descriptive or mixed-methods outcomes. No randomized trials or rigorous studies were identified. Dropout rates ranged widely, and adverse reactions were not evident. Reported satisfaction was high and benefits of relaxation, reductions in mental health symptoms, and improvements in pain and physical and cognitive functioning were noted. Limitations: All the studies were non-rigorous and relatively small, with no comparison groups, or follow-up assessments; in many cases, posttraumatic stress symptoms were not formally assessed. Conclusions: The paucity and lack of rigor of the studies identified for this review highlights the need for larger, methodologically sound clinical trials. The reviewed studies suggest that TCQ practices have the potential to reduce symptoms and improve functioning for individuals exposed to trauma and provide evidence that TCQ is feasible, acceptable, and low risk in these populations. Possible mechanistic pathways supporting TCQ as a treatment for posttraumatic stress are considered.

Ratings of Perceived Exertion During Walking: Predicting Major Mobility Disability and Effect of Structured Physical Activity in Mobility-Limited Older Adults.

BACKGROUND: This study evaluated the association between ratings of perceived exertion (RPE) of walking and major mobility disability (MMD), as well as their transitions in response to a physical activity (PA) compared to a health education (HE) program. METHODS: Older adults (n = 1633) who were at risk for mobility impairment were randomized to structured PA or HE programs. During a 400 m walk, participants rated exertion as "light" or "hard." An MMD event was defined as the inability to walk 400 m. MMD events and RPE values were assessed every 6 months for an average of 2.6 years. RESULTS: Participants rating their exertion as "hard" had a nearly threefold higher risk of MMD compared with those rating their exertion as "light" (HR: 2.61, 95% CI: 2.19-3.11). The association was held after adjusting for disease conditions, depression, cognitive function, and walking speed (HR: 2.24, 95% CI: 1.87-2.69). The PA group was 25% more likely to transition from "light" to "hard" RPE than the HE group (HR: 1.25, 95% CI: 1.05-1.49). Additionally, the PA group was 27% (HR: 0.73, 95% CI: 0.55 - 0.97) less likely to transition from a "hard" RPE to inability to walk 400 m and was more likely to recover their ability to walk 400 m by transitioning to a "hard" RPE (HR: 2.10, 95% CI: 1.39-3.17) than the HE group. CONCLUSIONS: Older adults rating "hard" effort during a standardized walk test were at increased risk of subsequent MMD. A structured PA program enabled walking recovery, but was more likely to increase transition from "light" to "hard" effort, which may reflect the greater capacity to perform the test.

Wearable Activity Monitor Use Is Associated With the Aerobic Physical Activity Guidelines and Walking Among Older Adults.

PURPOSE: To examine wearable activity monitor (WAM) use and its association with meeting the 2008 aerobic Physical Activity Guidelines (PAG) and walking among older adults. DESIGN: Cross-sectional. SETTING: FallStyles 2015 national consumer panel survey. SAMPLE: 1,317 U.S. adults aged ≥ 60 years. MEASURES: Self-reported WAM use, meeting aerobic PAG, and walking. Covariates included age, sex, race/ethnicity, education level, marital status, annual household income, and geographic region of the country. ANALYSIS: Chi-square tests to examine associations between WAM use and respondent demographic characteristics. Logistic regressions to explore associations between WAM use and meeting aerobic PAG and walking adjusted for demographics (e.g., education, income). RESULTS: Among older adults, 8.0% were current WAM users and 11.3% were past WAM users. Current WAM use was most prevalent among those aged 65-74 (16.6%), females (9.4%), college graduates (13.8%), and those with incomes $75,000-$99,999 (14.8%). Current WAM users were more likely than never WAM users to report meeting aerobic PAG (OR: 3.98; 95% CI: 2.07, 7.66) and walking (OR: 3.90; 95% CI: 1.57, 9.69). Past and never WAM use were not associated with meeting aerobic PAG or walking. CONCLUSION: We found current WAM use is associated with meeting the aerobic PAG and walking among older adults. Further longitudinal research is needed to understand whether WAM could promote increased PA among older adults.

Patient-specific reference values for objective physical function tests: data from the Osteoarthritis Initiative.

INTRODUCTION/OBJECTIVE: We aimed to establish sex-specific reference values of objective physical function tests among individuals with or at risk for knee osteoarthritis (KOA) across subsets of age, radiographic KOA severity, and body mass index (BMI). METHOD: We included Osteoarthritis Initiative participants with data for objective physical function tests, sex, age, BMI, and radiographic KOA severity (Kellgren-Lawrence [KL] grade) at baseline. Objective physical function was quantified with 20-m walk speed, chair-stand speed, 400-m walk time, and knee extension and flexion strength. We created participant characteristic subsets for sex, age, KL grade, and BMI. Reference values were created as percentiles from minimum to maximum in 10% increments for each combination of participant characteristic subsets. Previously established clinically important differences for 20-m walk speed and knee extension strength were used to highlight clinically relevant differences. RESULTS: Objective physical function reference values tables and an interactive reference value table were created across all combinations of sex, age, KL grade, and BMI among 3860 individuals with or at risk for KOA. Clinically relevant differences exist for 20-m walk speed and knee extension strength between males and females across age groups, KL grades, and BMI categories. CONCLUSIONS: Establishing an individual's relative level of objective physical function by comparing their performance to individuals with similar sex, age, KL grade, or BMI may help improve interpretation of physical function performance. The interactive reference value table will provide clinicians and researchers a clinically accessible avenue to use these reference values.Key Points• Since greater age, radiographic knee osteoarthritis severity, and body mass index are all associated with worse objective physical function, reference values should consider the complex inter-play among these patient characteristics.• This study provides objective physical function reference values among subsets of individuals across the spectrum of sex, age groups, radiographic knee osteoarthritis severity, and body mass index categories.• These reference values offer a more patient-centered approach for interpreting an individual's relative level of objective physical function by comparing them to a more homogeneous group of individuals with similar participant characteristics.• We have provided a clinically accessible interactive table that will enable clinicians and researchers to input their patient's data to quickly and efficiently determine a patient's relative objective physical function compared to individual's with similar characteristics.

Association between Pre-Intervention Physical Activity Level and Treatment Response to Exercise Therapy in Persons with Knee Osteoarthritis - An Exploratory Study.

OBJECTIVE: Examine whether pre-intervention physical activity (PA) level is associated with achieving a positive treatment response of pain and/or function improvement after a 12-week exercise intervention in participants with knee osteoarthritis (OA). METHODS: We performed a secondary analysis of a randomized, single-blind comparative effectiveness trial showing similar treatment effects between Tai Chi mind-body exercise and standard physical therapy intervention for knee OA. Baseline PA was assessed by Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire and, in a subsample, by tri-axial accelerometers. OMERACT-OARSI dichotomous responder criteria was used for clinically meaningful improvement at follow-up. Associations between baseline self-reported PA by CHAMPS and outcomes of responders vs. non-responders (reference group) were assessed using logistic regressions, adjusting for demographic covariates. We compared objectively-measured PA by accelerometry between responders vs. non-responders using Wilcoxon tests. RESULTS: Our sample consisted of 166 participants with knee OA who completed both baseline and 12-week post-intervention evaluations: mean age 60.7 year (SD 10.5), BMI 32.4 kg/m2 (6.9), 119 (72%) women, and 138 (83%) OMERACT-OARSI responders. Neither time spent in total PA (OR 1.00; 95% CI 0.96, 1.03) nor time in moderate-to-vigorous (MV) PA (OR 1.01; 95% CI 0.93, 1.09) at pre-intervention were associated with being a responder. Similar findings were observed in 42 accelerometry sub-cohort participants. CONCLUSION: Pre-intervention PA level (subjective report or objective measurement) was not associated with whether an individual will achieve favorable treatment outcomes after a 12-week exercise intervention, suggesting that regardless of pre-intervention PA level, individuals will likely benefit from structured exercise interventions.

The Effects of Tai Chi Mind-Body Approach on the Mechanisms of Gulf War Illness: an Umbrella Review.

Gulf War illness (GWI) is a chronic and multisymptom disorder affecting military veterans deployed to the 1991 Persian Gulf War. It is characterized by a range of acute and chronic symptoms, including but not limited to, fatigue, sleep disturbances, psychological problems, cognitive deficits, widespread pain, and respiratory and gastrointestinal difficulties. The prevalence of many of these chronic symptoms affecting Gulf War veterans occur at markedly elevated rates compared to nondeployed contemporary veterans. To date, no effective treatments for GWI have been identified. The overarching goal of this umbrella review was to critically evaluate the evidence for the potential of Tai Chi mind-body exercise to benefit and alleviate GWI symptomology. Based on the most prevalent GWI chronic symptoms and case definitions established by the Centers for Disease Control and Prevention and the Kansas Gulf War Veterans Health Initiative Program, we reviewed and summarized the evidence from 7 published systematic reviews and meta-analyses. Our findings suggest that Tai Chi may have the potential for distinct therapeutic benefits on the major prevalent symptoms of GWI. Future clinical trials are warranted to examine the feasibility, efficacy, durability and potential mechanisms of Tai Chi for improving health outcomes and relieving symptomology in GWI.

Translating the Lifestyle Interventions and Independence for Elders Clinical Trial to Older Adults in a Real-World Community-Based Setting.

BACKGROUND: The Lifestyle Interventions and Independence for Elders (LIFE) clinical trial demonstrated that a structured program of physical activity (PA) reduced mobility-disability in older adults by up to 28%. It remains unknown whether the benefits of LIFE PA can be translated to older adults at risk for mobility-disability in real-world community-based settings. To address this knowledge gap, we conducted the ENhancing independence using Group-based community interventions for healthy AGing in Elders (ENGAGE) pilot study and examined the safety, feasibility, and preliminary effectiveness of translating LIFE PA to a community-based senior center. METHODS: Forty older adults with severe lower extremity functional limitations (age: 76.9 ± 7.3 years; body mass index: 32.7 ± 8 kg/m2; 85% female; short physical performance battery score: 6.3 ± 2.2) were randomized to 24 weeks of PA or a health education control intervention. RESULTS: Community-based PA was safe (serious adverse events: PA vs health education, 0:2; nonserious adverse events: PA vs health education, 3:1) and participants successfully adhered to the PA intervention (65.2%). Compared to health education, PA participants who attended ≥25% of scheduled visits had meaningful and sustained short physical performance battery improvements at follow-up (between group short physical performance battery score differences: ~0.7 units). CONCLUSIONS: ENGAGE has demonstrated the preliminary safety, feasibility, and effectiveness of LIFE PA in a real-world community-based setting. Larger-scale translational studies are needed to further disseminate the benefits of LIFE PA to vulnerable older adults in a variety of community-based settings.

Progressive Resistance Training Improves Torque Capacity and Strength in Mobility-Limited Older Adults.

BACKGROUND: Progressive resistance training (PRT) is consistently shown to improve muscle strength in older adults. The efficacy of PRT to improve muscle fatigue in older adults with demonstrated mobility limitations remains unclear. METHODS: Mobility-limited (Short Physical Performance Battery [SPPB] ≤ 9) older adults (age 70-92 years) were recruited for this study and randomized to either PRT or home-based flexibility (FLEX) 3 d/wk for 12 weeks. Muscle fatigue and strength outcomes were assessed at baseline and 12 weeks. The primary outcome was torque capacity, a composite measure of strength and fatigue, defined as the sum of peak torques from an isokinetic fatigue test. RESULTS: Seventy participants were randomized (mean [SD] age 78.9 [5.4] years; 60% female; mean [SD] SPPB 7.5 [1.6]). At follow-up, the PRT group improved significantly in torque capacity, mean between-group difference (95% confidence interval) 466.19 (138.4, 793.97) Nm (p = .006), and maximal strength 127.3 (60.96, 193.61) Nm (p = .0003), when compared with FLEX group. Neither group demonstrated significant changes in muscle fatigue or torque variability. CONCLUSION: Twelve weeks of PRT improved torque capacity, as well as strength in mobility-limited older adults. These results demonstrate PRT improves multiple age-related muscular impairments.

Effect of tai chi versus aerobic exercise for fibromyalgia: comparative effectiveness randomized controlled trial.

OBJECTIVES: To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. DESIGN: Prospective, randomized, 52 week, single blind comparative effectiveness trial. SETTING: Urban tertiary care academic hospital in the United States between March 2012 and September 2016. PARTICIPANTS: 226 adults with fibromyalgia (as defined by the American College of Rheumatology 1990 and 2010 criteria) were included in the intention to treat analyses: 151 were assigned to one of four tai chi groups and 75 to an aerobic exercise group. INTERVENTIONS: Participants were randomly assigned to either supervised aerobic exercise (24 weeks, twice weekly) or one of four classic Yang style supervised tai chi interventions (12 or 24 weeks, once or twice weekly). Participants were followed for 52 weeks. Adherence was rigorously encouraged in person and by telephone. MAIN OUTCOME MEASURES: The primary outcome was change in the revised fibromyalgia impact questionnaire (FIQR) scores at 24 weeks compared with baseline. Secondary outcomes included changes of scores in patient's global assessment, anxiety, depression, self efficacy, coping strategies, physical functional performance, functional limitation, sleep, and health related quality of life. RESULTS: FIQR scores improved in all five treatment groups, but the combined tai chi groups improved statistically significantly more than the aerobic exercise group in FIQR scores at 24 weeks (difference between groups=5.5 points, 95% confidence interval 0.6 to 10.4, P=0.03) and several secondary outcomes (patient's global assessment=0.9 points, 0.3 to 1.4, P=0.005; anxiety=1.2 points, 0.3 to 2.1, P=0.006; self efficacy=1.0 points, 0.5 to 1.6, P=0.0004; and coping strategies, 2.6 points, 0.8 to 4.3, P=0.005). Tai chi treatment compared with aerobic exercise administered with the same intensity and duration (24 weeks, twice weekly) had greater benefit (between group difference in FIQR scores=16.2 points, 8.7 to 23.6, P<0.001). The groups who received tai chi for 24 weeks showed greater improvements than those who received it for 12 weeks (difference in FIQR scores=9.6 points, 2.6 to 16.6, P=0.007). There was no significant increase in benefit for groups who received tai chi twice weekly compared with once weekly. Participants attended the tai chi training sessions more often than participants attended aerobic exercise. The effects of tai chi were consistent across all instructors. No serious adverse events related to the interventions were reported. CONCLUSION: Tai chi mind-body treatment results in similar or greater improvement in symptoms than aerobic exercise, the current most commonly prescribed non-drug treatment, for a variety of outcomes for patients with fibromyalgia. Longer duration of tai chi showed greater improvement. This mind-body approach may be considered a therapeutic option in the multidisciplinary management of fibromyalgia. TRIAL REGISTRATION: ClinicalTrials.gov NCT01420640.

Effect of Physical Activity on Frailty: Secondary Analysis of a Randomized Controlled Trial.

Background: Limited evidence suggests that physical activity may prevent frailty and associated negative outcomes in older adults. Definitive data from large long-term randomized trials are lacking. Objective: To determine whether a long-term, structured, moderate-intensity physical activity program is associated with a lower risk for frailty and whether frailty status alters the effect of physical activity on the reduction in major mobility disability (MMD) risk. Design: Multicenter, single-blind, randomized trial. Setting: 8 centers in the United States. Participants: 1635 community-dwelling adults, aged 70 to 89 years, with functional limitations. Intervention: A structured, moderate-intensity physical activity program incorporating aerobic, resistance, and flexibility activities or a health education program consisting of workshops and stretching exercises. Measurements: Frailty, as defined by the SOF (Study of Osteoporotic Fractures) index, at baseline and 6, 12, and 24 months, and MMD, defined as the inability to walk 400 m, for up to 3.5 years. Results: Over 24 months of follow-up, the risk for frailty (n = 1623) was not statistically significantly different in the physical activity versus the health education group (adjusted prevalence difference, -0.021 [95% CI, -0.049 to 0.007]). Among the 3 criteria of the SOF index, the physical activity intervention was associated with improvement in the inability to rise from a chair (adjusted prevalence difference, -0.050 [CI, -0.081 to -0.020]). Baseline frailty status did not modify the effect of physical activity on reducing incident MMD (P for interaction = 0.91). Limitation: Frailty status was neither an entry criterion nor a randomization stratum. Conclusion: A structured, moderate-intensity physical activity program was not associated with a reduced risk for frailty over 2 years among sedentary, community-dwelling older adults. The beneficial effect of physical activity on the incidence of MMD did not differ between frail and nonfrail participants. Primary Funding Source: National Institute on Aging, National Institutes of Health.

Nutritional Supplementation With Physical Activity Improves Muscle Composition in Mobility-Limited Older Adults, The VIVE2 Study: A Randomized, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: Nutritional supplementation and physical activity have been shown to positively influence muscle mass and strength in older adults. The efficacy of long-term nutritional supplementation in combination with physical activity in older adults remains unclear. METHODS: Mobility-limited (short physical performance battery [SPPB] ≤9) and vitamin D insufficient (serum 25(OH) D 9-24 ng/mL) older adults were recruited for this study. All subjects participated in a physical activity program. Subjects were randomized to consume a daily nutritional supplement (150 kcal, 20 g whey protein, 800 IU vitamin D, 119 mL beverage) or placebo (30 kcal, nonnutritive, 119 mL). In a prespecified secondary analysis, we examined total-body composition (dual energy X-ray absorptiometry), thigh composition (computed tomography), and muscle strength, power, and quality before and after the 6-month intervention. RESULTS: One hundred and forty-nine subjects were randomized into the study [mean (standard deviation, SD) age 78.5 (5.4) years; 46.3% female; mean (SD) short physical performance battery 7.9 (1.2); mean (SD) vitamin D 18.7 (6.4) ng/mL]. After the intervention period both groups demonstrated improvements in muscle strength, body composition, and thigh composition. Nutritional supplementation lead to further losses of intermuscular fat (p = .049) and increased normal muscle density (p = .018). CONCLUSIONS: Six months of physical activity resulted in improvements in body composition, subcutaneous fat, intermuscular fat, and strength measures. The addition of nutritional supplementation resulted in further declines in intermuscular fat and improved muscle density compared to placebo. These results suggest nutritional supplementation provides additional benefits to mobility-limited older adults undergoing exercise training. ClinicalTrials.gov Identifier: NCT01542892.