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Background Overweight and obesity are associated with adverse functional outcomes in people with peripheral artery disease (PAD). The effects of weight loss in people with overweight/obesity and PAD are unknown. Methods The PROVE (Promote Weight Loss in Obese PAD Patients to Prevent Mobility Loss) Trial is a multicentered randomized clinical trial with the primary aim of testing whether a behavioral intervention designed to help participants with PAD lose weight and walk for exercise improves 6‐minute walk distance at 12‐month follow‐up, compared with walking exercise alone. A total of 212 participants with PAD and body mass index ≥25 kg/m2 will be randomized. Interventions are delivered using a Group Mediated Cognitive Behavioral intervention model, a smartphone application, and individual telephone coaching. The primary outcome is 12‐month change in 6‐minute walk distance. Secondary outcomes include total minutes of walking exercise/wk at 12‐month follow‐up and 12‐month change in accelerometer‐measured physical activity, the Walking Impairment Questionnaire distance score, and the Patient‐Reported Outcomes Measurement Information System mobility questionnaire. Tertiary outcomes include 12‐month changes in perceived exertional effort at the end of the 6‐minute walk, diet quality, and the Short Physical Performance Battery. Exploratory outcomes include changes in gastrocnemius muscle biopsy measures of mitochondrial cytochrome C oxidase activity, mitochondrial biogenesis, capillary density, and inflammatory markers. Conclusions The PROVE randomized clinical trial will evaluate the effects of exercise with an intervention of coaching and a smartphone application designed to achieve weight loss, compared with exercise alone, on walking performance in people with PAD and overweight/obesity. Results will inform optimal treatment for the growing number of patients with PAD who have overweight/obesity. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04228978.

Fibromyalgia (FM) is a common and disabling disorder characterized by chronic widespread pain, fatigue, and dyscognition. Previous studies have shown strong positive correlations between pain, fatigue, and dyscognition. However, bidirectional relationships, particularly with dyscognition modeled as a predictor, have rarely been established. The purpose of this study was to examine the bidirectional, predictive nature of the relationships between these FM symptoms. Pain, fatigue, and dyscognition were measured via the Brief Pain Inventory, Multidimensional Fatigue Inventory, and Multiple Ability Self-Report Questionnaire at baseline and a 2-year follow-up in a large sample of 450 well-characterized female patients with FM. Relationships between FM symptoms were evaluated using a cross-lagged, longitudinal model. Dyscognition, pain, and fatigue were positively correlated at both baseline and follow-up (rs .13 -.53, Ps

Objective: To evaluate the association between statin use and symptom severity, tender point count, fatigue, cognition, mood, and sleep issues in patients with fibromyalgia (FM). Methods: Between May 2012 and November 2013, 668 patients with FM were surveyed. Patients were stratified into statin users and statin nonusers. Primary outcome was FM symptom severity (FIQ-R questionnaire) and tender point count. Secondary outcomes included fatigue (MFI-20), cognitive dysfunction (MASQ), anxiety (GAD-7), depression (PHQ-9), and sleep issues (SPI-II). Regression analysis assessed for differences in these clinical outcomes between statin users and statin nonusers and adjusted for age, sex, body mass index, ethnicity, tobacco use, opioid use, and neuropathic medication use. Results: Of the FM patients, 79 (11.8%) were statin users, whereas 589 (88.2%) reported no current statin use. Compared with the control cohort, statin users were older (55.0±11.3 years vs 46.2±12.9 years; P

Objective: To investigate sex-related differences in patients with fibromyalgia (FM) in terms of demographic characteristics and clinical features, including tender point count (TPC), mood disorders, sleep problems, FM symptom severity, fatigue, cognitive dysfunction, and quality of life (QOL). Patients and Methods: We studied 668 consecutive patients with FM (606 women) from May 1, 2012, to November 30, 2013. Validated questionnaires assessed outcomes of depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), sleep problems (Medical Outcomes Study Sleep Scale), FM symptom severity (Revised Fibromyalgia Impact Questionnaire), fatigue (Multidimensional Fatigue Inventory), cognitive dysfunction (Multiple Ability Self-report Questionnaire), and QOL (36-Item Short Form Health Survey). Nonparametric Mann-Whitney U and Pearson χ2 tests were used to compare continuous and categorical outcome measures, respectively, between men and women. Linear regression models were performed for all continuous dependent variables, adjusting for age, body mass index, ethnicity, marital status, and highest education level completed. P

Objective: To evaluate the association between smoking and cognitive function in patients with fibromyalgia. Patients and Methods: We surveyed 668 patients with fibromyalgia from May 1, 2012 through November 30, 2013 at a major tertiary referral center. Patients were categorized by smoking status. Primary outcome of interest was cognitive function (MASQ questionnaire), and secondary outcomes included fibromyalgia symptom severity (FIQ-R questionnaire), quality of life (SF-36 questionnaire), fatigue (MFI-20 questionnaire), sleep (MOS-sleep scale), anxiety (GAD-7 questionnaire), and depression (PHQ-9 questionnaire). Independent Students' t-tests and χ2 tests were performed for continuous and categorical variables, respectively. Univariate regression analysis identified variables predictive of outcomes, adjusting for age, gender, body mass index, marital status, and educational level. Results: Ninety-four (14.07%) patients self-identified as smokers. There was an association of lower education level, unmarried status, and younger age in smokers compared with nonsmokers. In the adjusted univariate regression analysis, fibromyalgia smokers reported greater perceived total cognitive dysfunction (P=.009) and greater subscale scores of perceived difficulty in language (P=.03), verbal memory (P=.003), visual-spatial memory (P=.02), and attention (P=.04) compared with nonsmokers with fibromyalgia. For secondary outcomes, smokers with fibromyalgia reported greater severity of fibromyalgia-related symptoms (P=.006), worse quality-of-life index in the mental component scale (P=.02), greater sleep problems (P=.01), and increased anxiety (P=.001) compared with nonsmokers who had fibromyalgia. Conclusion: In patients with fibromyalgia, smoking is a risk factor for cognitive dysfunction. Moreover, smokers with fibromyalgia were more likely to report increased severity of fibromyalgia symptoms, worse quality of life, more sleep problems, and increased anxiety compared with nonsmokers with fibromyalgia.

Abstract Background Using self-report questionnaires of key fibromyalgia symptom domains (pain, fatigue, sleep disturbance, function, stiffness, dyscognition, depression, and anxiety), we previously identified four unique symptom clusters. The purpose of this study was to examine the stability of fibromyalgia symptom clusters between baseline and 2-year follow-up. Methods Women with a diagnosis of fibromyalgia completed the Brief Pain Inventory, Profile of Mood States, Medical Outcomes Study Sleep measure, Multidimensional Fatigue Inventory, Multiple Ability Self-Report Questionnaire, Revised Fibromyalgia Impact Questionnaire, and the 36-Item Short Form Survey Instrument at baseline. Follow-up measures were completed approximately 2 years later. The hierarchical agglomerative clustering algorithm previously developed was applied; agreement between baseline and follow-up was assessed with the κ statistic. Results Among 433 participants, the mean age was 56 (range 20–85) years. The median Revised Fibromyalgia Impact Questionnaire total score was 57 (range 8–96). More than half of participants (58%) remained in the same cluster at follow-up as at baseline, which represented moderate agreement between baseline and follow-up (κ = 0.44, 95% confidence interval (CI) 0.37–0.50). Only two patients changed from high symptom intensity to low symptom intensity; similarly, only three moved from low to high. Conclusions Fibromyalgia patients classified into four unique symptom clusters based on the key domains of pain, fatigue, sleep disturbance, function, stiffness, dyscognition, depression, and anxiety showed moderate stability in cluster assignment after 2 years. Few patients moved between the two extremes of severity, and it was slightly more common to move to a lower symptom level than to worsen. Trial registration Not applicable.