Uptake and outcomes of supervised exercise therapy for peripheral artery disease: The importance of vascular medicine specialists at a large midwestern health care system during the first 5 years of CMS reimbursement.

BACKGROUND: Supervised exercise therapy (SET) is the cornerstone of medical therapy for symptomatic peripheral artery disease (PAD). Despite the efficacy of SET, initial reports following the 2017 Centers for Medicare and Medicaid Services (CMS) reimbursement decision indicate low SET uptake, referral, and completion. Vascular medicine specialists are key to the success of such programs. We examined rates of SET referral, completion, and outcomes in a health system with a robust SET program during the first 5 years of CMS reimbursement. METHODS: A retrospective chart review of patients with PAD referred to SET between October 1, 2017 and December 31, 2022 was conducted. Patient demographic and medical characteristics, SET indication, referring provider specialty, SET participation (e.g., exercise modality, number of sessions, treadmill prescription), and outcomes were abstracted. Descriptive statistics, t-tests, and multiple linear regression were used to examine the sample, evaluate outcomes, and explore outcomes by relevant covariates (i.e., age, sex, referring provider specialty). RESULTS: Of 5320 patients with PAD, N = 773 were referred to SET; N = 415 enrolled and were included in the present study. Vascular medicine and vascular surgery specialists were the two primary sources of referrals (30.6% and 51.6%, respectively). A total of 207 patients (49.9%) completed SET. Statistically significant and clinically meaningful improvements were observed in all outcomes. CONCLUSION: SET referral and completion rates are low in the 5 years following CMS reimbursement, despite the advocacy of vascular medicine specialists. SET is effective in improving patient functional capacity and quality of life. Additional efforts are needed to increase both SET availability and referrals as part of comprehensive treatment of PAD.

Risk Factors for Tube Feeding at Discharge in Infants Undergoing Neonatal Surgery for Congenital Heart Disease: A Systematic Review.

Approximately 30-50% of infants undergoing neonatal surgery for congenital heart disease (CHD) cannot meet oral feeding goals by discharge and require feeding tube support at home. Feeding tubes are associated with increased readmission rates and consequent hospital, payer, and family costs, and are a burden for family caregivers. Identification of modifiable risk factors for oral feeding problems could support targeted care for at-risk infants. Therefore, the aim of this systematic review is to determine risk factors for tube feeding at discharge in infants undergoing neonatal surgery for CHD. Following Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, a search was conducted using MEDLINE, CINAHL, and Cochrane Database of Systematic Reviews. Studies published before 2010 were excluded. The search resulted in 607 records, of which 18 were included. Studies were primarily retrospective cohort designs and results were often inconsistent. Study quality was assessed using the Joanna Briggs Critical Appraisal Tools. As a group, the studies exhibited substantial risk for bias. Based on the findings, infants who struggle with feeding preoperatively, experience increased nil per os duration and/or low oral feeding volume postoperatively, experience increased duration of mechanical ventilation, or have vocal cord dysfunction may be at risk for tube feeding at hospital discharge. Factors warranting further examination include cardiac physiology (e.g., aortic arch obstruction) and the relationship between neurodevelopment and oral feeding. Clinicians should use caution in assuming risk for an individual and prioritize early implementation of interventions that facilitate oral feeding development.

Single-leg exercise training augments in vivo skeletal muscle oxidative flux and vascular content and function in adults with type 2 diabetes.

KEY POINTS: People with type 2 diabetes (T2D) have impaired skeletal muscle oxidative flux due to limited oxygen delivery. In the current study, this impairment in oxidative flux in people with T2D was abrogated with a single-leg exercise training protocol. Additionally, single-leg exercise training increased skeletal muscle CD31 content, calf blood flow and state 4 mitochondrial respiration in all participants. ABSTRACT: Cardiorespiratory fitness is impaired in type 2 diabetes (T2D), conferring significant cardiovascular risk in this population; interventions are needed. Previously, we reported that a T2D-associated decrement in skeletal muscle oxidative flux is ameliorated with acute use of supplemental oxygen, suggesting that skeletal muscle oxygenation is rate-limiting to in vivo mitochondrial oxidative flux during exercise in T2D. We hypothesized that single-leg exercise training (SLET) would improve the T2D-specific impairment in in vivo mitochondrial oxidative flux during exercise. Adults with (n = 19) and without T2D (n = 22) with similar body mass indexes and levels of physical activity participated in two weeks of SLET. Following SLET, in vivo oxidative flux measured by 31 P-MRS increased in participants with T2D, but not people without T2D, measured by the increase in initial phosphocreatine synthesis (P = 0.0455 for the group × exercise interaction) and maximum rate of oxidative ATP synthesis (P = 0.0286 for the interaction). Additionally, oxidative phosphorylation increased in all participants with SLET (P = 0.0209). After SLET, there was no effect of supplemental oxygen on any of the in vivo oxidative flux measurements in either group (P > 0.02), consistent with resolution of the T2D-associated oxygen limitation previously observed at baseline in subjects with T2D. State 4 mitochondrial respiration also improved in muscle fibres ex vivo. Skeletal muscle vasculature content and calf blood flow increased in all participants with SLET (P < 0.0040); oxygen extraction in the calf increased only in T2D (P = 0.0461). SLET resolves the T2D-associated impairment of skeletal muscle in vivo mitochondrial oxidative flux potentially through improved effective blood flow/oxygen delivery.

Acute effects of sedentary breaks on vascular health in adults at risk for type 2 diabetes: A systematic review.

The aim of this systematic review was to evaluate the available evidence regarding the acute effects of interrupting/breaking up prolonged sedentary behavior (SB) on vascular health among individuals at elevated risk for type 2 diabetes (T2D). Searches of MEDLINE, Embase, Web of Science, and Cochrane Library databases were conducted on April 7, 2020. Included studies: (1) examined the effect of breaking up prolonged SB in adults with or at elevated risk for T2D and (2) assessed a vascular health outcome, such as blood pressure (BP), flow-mediated dilation (FMD), pulse-wave velocity, or endothelin-1. A total of 20 articles (17 unique studies) were included. Only three studies reported adequate statistical power for the specified vascular outcome. The available evidence suggests that light and moderate intensity activity breaks are effective in acutely lowering BP when compared to prolonged sitting. The small number of studies that included FMD or other vascular outcomes prohibits conclusions regarding the impact of SB breaks on these outcomes. Few studies evaluating the impact of breaking up SB among adults at risk for T2D have included and been adequately powered to examine vascular outcomes, but our preliminary finding, that certain SB breaks improve BP, provides proof-of-concept for this line of inquiry. Future studies should examine both the acute and chronic vascular effects of breaking up SB among individuals most vulnerable to the effects of SB (e.g. older adults, those with T2D), as these individuals are both highly sedentary and at greatest risk of poor health outcomes. PROSPERO ID: CRD42020183423.

Influence of Changes in Sedentary Time on Outcomes of Supervised Exercise Therapy in Individuals with Comorbid Peripheral Artery Disease and Type 2 Diabetes.

BACKGROUND: Although supervised exercise therapy (SET) is effective in improving walking distance among adults with symptomatic peripheral artery disease (PAD), some research suggests that individuals with comorbid PAD and type 2 diabetes mellitus (T2DM) may experience a blunted response to SET. It is unknown whether free-living sedentary time changes during SET, and if increases in sedentary time could, in part, explain poor response to SET. The purposes of this pilot study were to (1) determine if older adults with PAD (with and without T2DM) engaging in SET change their sedentary behavior and (2) examine the relationship between changes in sedentary behavior and SET outcomes. We hypothesized that decreased sedentary time during SET would be associated with greater improvements in six-minute walk test (6MWT) total distance and other key SET outcomes. METHODS: Participants (n = 44) initiating a 12-week SET program completed the 6MWT, Short Physical Performance Battery, Walking Impairment Questionnaire, and accelerometer-assessed sedentary behavior at SET initiation, 6 weeks, and 12 weeks. RESULTS: Participants' mean age was 72.3 (7.1) years, mean ankle-brachial index was 0.71 (0.25), and 47.7% were female. On average, sedentary time did not change after SET, although there was substantial variability (-40% to +38% change in minutes of sedentary time/day). Participants with T2DM experienced greater improvements in claudication onset distance than participants without T2DM (mean = 35 m, P = 0.044, 95% confidence interval = 1.6 to 115.4 m). Neither changes in sedentary time from baseline to 6 weeks (P = 0.419) nor T2DM (P = 0.154) predicted changes in 6MWT total distance from baseline to 12 weeks. CONCLUSIONS: As SET availability increases, further examination of factors that may influence SET outcomes will help maximize benefits of this proven therapy.

Variability in Individual Response to Aerobic Exercise Interventions Among Older Adults.

Although a plethora of evidence supports the benefits of exercise among older adults, a majority of studies have emphasized group differences, while giving little, if any, attention to individual differences. Given the lack of data on variability in response, the present review examined how nonresponse to aerobic exercise has been defined in older adult populations and characteristics associated with nonresponse among older adults. The results of this review suggest that interindividual variability in response of maximal oxygen consumption to aerobic exercise interventions is prevalent among older adults (1.4-63.4%); age, sex, race, and body mass index may not be critical determinants of nonresponse; whereas health status, baseline fitness, and exercise dose appear important. Future intervention studies should evaluate and report the variability in individual response of older adults to exercise; investigators should develop programs that allow for modification of components to assist older adults in achieving optimal benefit from exercise programs.

Fear of falling among community-dwelling older adults: A scoping review to identify effective evidence-based interventions.

Fear of falling presents a significant problem for many older adults by reducing physical function and increasing the risk of future falls. Several different types of interventions have improved fear of falling and a summary of efficacious interventions will help clinicians recommend treatment options. Using the Arksey and O'Malley Framework for scoping reviews, the purpose of this review was to identify efficacious interventions for treating fear of falling among community-dwelling older adults in order to provide a list of potential treatment options for care providers. A total of 45 publications were identified for inclusion in this review.

What we learned through asking about evidence: A model for interdisciplinary student engagement.

Traditional university learning modalities of lectures and examinations do not prepare students fully for the evolving and complex world of gerontology and geriatrics. Students involved in more active, self-directed learning can develop a wider breadth of knowledge and perform better on practical examinations. This article describes the Evidence in Aging (EIA) study as a model of active learning with the aim of preparing students to be effective interdisciplinary researchers, educators, and leaders in aging. We focus particularly on the experiences and reflections of graduate students who collaborated with faculty mentors on study design, data collection, and analysis. Students acquired new methodological skills, gained exposure to diverse disciplines, built interdisciplinary understanding, and cultivated professional development. The EIA study is a model for innovative student engagement and collaboration, interactive learning, and critical scholarly development. Lessons learned can be applied to a range of collaborative research projects in gerontology and geriatrics education.

Self-Regulatory Fatigue: A Missing Link in Understanding Fibromyalgia and Other Chronic MultiSymptom Illnesses.

OBJECTIVE: Patients with chronic multisymptom illnesses such as fibromyalgia syndrome (FMS) are experiencing a multitude of physical and mental challenges. Facing such challenges may drain capacity to self-regulate, and research suggests patients with these illnesses may experience self-regulatory fatigue (SRF). This study sought to examine whether SRF can be associated with quality of life (QoL) in patients with FMS. METHODS: Patients (N = 258) diagnosed with FMS completed self-report measures related to demographics, SRF (Self-Regulatory Fatigue 18 [SRF-18]), anxiety (Generalized Anxiety Disorder questionnaire [GAD-7]), depression (Patient Health Questionnaire [PHQ-9]), physical fatigue (Multidimensional Fatigue Inventory [MFI]), symptoms related to FMS (Fibromyalgia Impact Questionnaire [FIQ]), and QoL (36-Item Short-Form Health Survey [SF-36]). RESULTS: Hierarchical regressions showed higher SRF to be associated with lower QoL in terms of lower overall physical QoL, with subscales related to physical functioning, role limitations-physical, bodily pain, and general health (all P's > 0.001), as well as lower overall mental QoL, with subscales related to vitality, social functioning, role limitations-emotional, and mental health (all P's > 0.001). Including traditional predictors such as anxiety, depression, physical fatigue, and FMS-related symptoms as covariates in the analyses reduced the link between SRF and QoL somewhat, but the associations remained generally strong, particularly for SRF and mental QoL. CONCLUSION: This is the first study to show higher SRF relating to lower QoL for patients with FMS. Results suggest that SRF is distinct from anxiety, depression, and fatigue, and predicts QoL above and beyond these traditional factors in the area of chronic multisymptom illnesses such as FMS. SRF may be a "missing link" in understanding the complex nature of chronic multisymptom illnesses.

Perceived dyscognition reported by patients with fibromyalgia.

OBJECTIVES: Patients with fibromyalgia often report dyscognition as a symptom; however, the literature on this symptom is sparse. Our objective for this cross-sectional study was to characterize dyscognition among patients with fibromyalgia, identify comorbid symptoms associated with dyscognition, and evaluate its relation with fibromyalgia severity. METHODS: Dyscognition was assessed with the Multiple Abilities Self-report Questionnaire (MASQ) for 681 patients with fibromyalgia. Other assessed comorbid symptoms were pain, fatigue, sleep problems, mood, physical and mental health, and autonomic function. Correlation and regression modeling were used to identify relations between the MASQ subscales and other fibromyalgia symptoms. Mixed analysis of variance was used to examine the profile of dyscognition in different levels of fibromyalgia. MASQ subscale scores from a previously described healthy normal control population were used for comparison. RESULTS: The mean (SD) age of the study patients was 55.8 (12.6) years, and most patients were female (93%) and white (91%). Perceived dyscognition was most related to depression, anxiety, and autonomic function. Across all fibromyalgia severity levels, patients had significantly higher levels of perceived dyscognition than the healthy controls. Significant differences existed for the MASQ total and most MASQ subscales among patients with mild, moderate, and severe fibromyalgia. CONCLUSIONS: Our study results provide further evidence that perceived dyscognition in fibromyalgia is influenced by various comorbid symptoms. In treating patients with fibromyalgia who have dyscognition, clinicians should consider the multiple types of dyscognition and the effects of other fibromyalgia symptoms.

Fibromyalgia Flares: A Qualitative Analysis.

OBJECTIVE: Patients with fibromyalgia report periods of symptom exacerbation, colloquially referred to as "flares" and despite clinical observation of flares, no research has purposefully evaluated the presence and characteristics of flares in fibromyalgia. The purpose of this qualitative study was to describe fibromyalgia flares in a sample of patients with fibromyalgia. METHODS: Using seven open-ended questions, patients were asked to describe how they perceived fibromyalgia flares and triggers and alleviating factors associated with flares. Patients were also asked to describe how a flare differs from their typical fibromyalgia symptoms and how they cope with fibromyalgia flares. Content analysis was used to analyze the text. RESULTS: A total of 44 participants completed the survey. Responses to the seven open-ended questions revealed three main content areas: causes of flares, flare symptoms, and dealing with a flare. Participants identified stress, overdoing it, poor sleep, and weather changes as primary causes of flares. Symptoms characteristic of flares included flu-like body aches/exhaustion, pain, fatigue, and variety of other symptoms. Participants reported using medical treatments, rest, activity and stress avoidance, and waiting it out to cope with flares. CONCLUSIONS: Our results demonstrate that periods of symptom exacerbation (i.e., flares) are commonly experienced by patients with fibromyalgia and symptoms of flares can be differentiated from every day or typical symptoms of fibromyalgia. Our study is the first of its kind to qualitatively explore characteristics, causes, and management strategies of fibromyalgia flares. Future studies are needed to quantitatively characterize fibromyalgia flares and evaluate mechanisms of flares.

Frequency of Migraine Headaches in Patients With Fibromyalgia.

OBJECTIVE: The purpose of this study was to evaluate the frequency of migraine headache in a large cohort of patients with fibromyalgia using a brief migraine headache-screening tool. BACKGROUND: Several studies report a high prevalence of fibromyalgia among patients with migraine headaches, but there is a dearth of research evaluating the frequency of migraine headaches in patients with fibromyalgia, despite clinical observations suggesting that migraine headaches are common in patients with fibromyalgia. DESIGN AND METHODS: This was a cross-sectional survey study. Patients (N = 3717) with a previous diagnosis of fibromyalgia who were members of the Mayo Clinic Fibromyalgia Registry were contacted by electronic survey and asked to complete a brief demographic and medical history questionnaire and the validated ID-Migraine screener. RESULTS: A total of 1730 patients (46.5%) completed the electronic survey. The majority of participants were white (97.2%), female (92.5%), with a mean age of 56.2 (±13.1) years. Of the respondents, 966 (55.8%) met criteria for migraine headaches. Hypertension (309 [32.3%] vs. 294 [40.1%], P = .004), asthma (312 [32.5%] vs. 189 [25.9%], P = .011), irritable bowel syndrome (520 [54.6%] vs. 348 [47.6], P = .017), chronic fatigue syndrome (486 [50.7%] vs. 271 [37.1], P < .0001), depression (634 [66.5%] vs. 413 [56.7%], P = .0002), anxiety (415 [43.5%] vs. 252 [34.7%], P = .0011), and post-traumatic stress disorder (172 [18.0%] vs. 96 [13.2%], P = .006) were all significantly more common in those who met criteria for migraine headaches than those who did not. CONCLUSION: The results of this study suggest that migraine headaches are common in patients with fibromyalgia. Clinicians who care for either population must be aware that these conditions commonly overlap and can significantly increase a patient's cumulative disease burden.

Early experience with a brief, multimodal, multidisciplinary treatment program for fibromyalgia.

Fibromyalgia is a complex heterogeneous disorder for which a multidisciplinary individualized approach is currently advocated. We executed a 1-week multidisciplinary fibromyalgia clinical program with seven patients, based on our experience with our existing 1.5-day multidisciplinary fibromyalgia program that has demonstrated both short- and long-term benefits. The current expanded program was not designed as a clinical study, but rather as a clinical feasibility assessment, and it was multidisciplinary in nature, with cognitive behavioral therapy, activity pacing, and graded exercise therapy as major components. We assessed changes in individual patients at 1 week and 3 months after the program with the use of validated self-report measures of pain, fatigue, and self-efficacy. All patients indicated at least small improvements in pain and physical symptoms at both 1 week and 3 months, and all but one patient showed improvement in self-efficacy at 1 week and 3 months. Similar trends were observed for fatigue. Based on our early clinical experience, we conclude that the 1-week multidisciplinary fibromyalgia program is logistically feasible and has potential for clinical efficacy. Further research is needed and is planned to test the clinical efficacy of this program and compare it with other interventions.

Development and Initial Validation of a Measure to Assess Self-Efficacy to Reduce Sedentary Behavior.

INTRODUCTION: The purpose of this study was to assess the reliability and construct validity of a measure designed to evaluate self-efficacy to reduce sedentary behavior (SB). METHODS: Initial instrument development was based on semistructured interviews and in-depth review of existing measures of self-efficacy for physical activity (PA). Items were drafted by the study authors and reviewed by SB experts. Participants recruited via Amazon Mechanical Turk completed the pool of items and the Exercise Confidence Survey and provided self-reported PA, SB, and demographic information. The sample was divided into two random halves, and exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were performed on each half, respectively. Internal consistency reliability (Cronbach's alpha) was calculated for the final scale. Initial criterion validity was examined in relation to self-reported SB and PA. Analyses were conducted in SAS 9.4 and Mplus 8.3. RESULTS: Data were collected from N = 818 adults (47.6% women, mean (standard deviation) age, 37.8 (10.6)). EFA results strongly supported a one-factor scale. Items with low factor loadings (<0.65) were dropped from the scale; 10 items were retained. CFA demonstrated that the 10-item measure fit the data well, but one item had a low factor loading. A final scale with nine items was retained, with good fit to the data ( χ2 (27) = 90.79, P < 0.0001, comparative fit statistic = 0.97, root mean square error of approximation = 0.08 [90% confidence interval, 0.06-0.09], standardized root mean square residual = 0.03), and all items had high factor loadings (>0.70). Internal consistency reliability was high ( α = 0.91). Self-efficacy to reduce SB was significantly and positively correlated with exercise confidence ( r = 0.32-0.38, P < 0.0001). CONCLUSIONS: We developed a nine-item measure of self-efficacy to reduce SB that demonstrates strong initial psychometric properties. Although related to exercise self-efficacy, self-efficacy to reduce SB represents a distinct construct.

Use of Cannabidiol in the Management of Insomnia: A Systematic Review.

Background: Cannabidiol (CBD), one of the major cannabinoids derived from the cannabis plant, is available over the counter. CBD is often used by patients for the management of insomnia, yet research supporting CBDs effectiveness as a treatment for insomnia is inadequate. Objective: The objective of this review was to critically evaluate the literature regarding the therapeutic benefits of CBD in the management of insomnia. Methods: A comprehensive search of the following databases from inception to December 29, 2021, was conducted: Ovid MEDLINE® and Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily, Ovid Embase, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus. The search included randomized controlled trials, nonrandomized experimental studies, cross-sectional studies, cohort studies, case series, and case reports. Risk of bias was assessed with the Agency for Healthcare Research and Quality design-specific recommended criteria. Results: Thirty-four studies were eligible for inclusion. All studies reported improvement in the insomnia symptoms of at least a portion of their participants. Of the 34 studies, 19 studies used CBD predominant therapy and 21 studies used nearly equal ratios of CBD to Δ9-tetrahydrocannabinol (THC). Of the studies that performed hypothesis testing, 4 of 7 studies with a CBD predominant arm and 12 of 16 studies with a nearly equal ratio of CBD to THC arm reported significant improvement in insomnia outcomes. However, only 2 of the 34 studies focused on patients with insomnia, of which 1 study was a case report. Additionally, several studies used nonvalidated subjective measures, and most studies failed to include objective measures for symptom assessment. Conclusions: The results of our systematic review suggest that CBD alone or with equal quantities of THC may be beneficial in alleviating the symptoms of insomnia. Nevertheless, future research assessing CBDs effectiveness in population of patients specifically with insomnia utilizing validated subjective and objective measures is necessary before definitive inferences can be made.

Obesity dominates early effects on cardiac structure and arterial stiffness in people with type 2 diabetes.

OBJECTIVE: Type 2 diabetes (T2D) and obesity are global epidemics leading to excess cardiovascular disease (CVD). This study investigates standard and novel cardiac MRI parameters to detect subclinical cardiac and central vascular dysfunction in inactive people with and without T2D. METHODS: Physically inactive age and BMI-similar premenopausal women and men with ( n  = 22) and without [ n  = 34, controls with overweight/obesity (CWO)] uncomplicated T2D were compared to an age-similar and sex-similar reference control cohort ( n  = 20). Left ventricular (LV) structure, function, and aortic stiffness were assessed by MRI. Global arterial pulse wave velocity (PWV) was assessed using carotid-to-femoral applanation tonometry. Regional PWV was measured via 2D phase-contrast MRI and 4D flow MRI. RESULTS: Global arterial PWV did not differ between CWO and T2D. 2D PC-MRI PWV in the ascending aorta was higher in people with T2D compared with CWOs ( P  < 0.01). 4D flow PWV in the thoracic aorta was higher in CWO ( P  < 0.01), and T2D ( P  < 0.001) compared with RC. End-diastolic volume, end-systolic volume, stroke volume, and cardiac output were lower in CWO and T2D groups compared with reference control. CONCLUSION: Subclinical changes in arterial stiffening and cardiac remodeling in inactive CWO and T2D compared with reference control support obesity and/or physical inactivity as determinants of incipient CVD complications in uncomplicated T2D. Future studies should determine the mechanistic causes of the CVD complications in greater detail in order to create therapeutic targets. CLINICAL TRIAL REGISTRATION: Cardiovascular Mechanisms of Exercise Intolerance in Diabetes and the Role of Sex (NCT03419195).

Study Design, Rationale, and Methodology for Promote Weight Loss in Patients With Peripheral Artery Disease Who Also Have Obesity: The PROVE Trial.

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.

Predictive Bidirectional Relations Between Pain, Fatigue, and Dyscognition in Fibromyalgia.

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<.01). Dyscognition at baseline was predictive of dyscognition (B=.76, ß=.75, P<.001), pain, (B=.01, ß=.09, P=.033) and fatigue (B=.05, ß=.08, P=.050) at follow-up. Pain at baseline was predictive of pain (B=.59, ß=.59, P<.001), dyscognition (B=.88, ß=.07, P=.022), and fatigue (B=.85, ß=.11, P=.004) at follow-up. Fatigue at baseline was only associated with fatigue (B=.61, ß=.60, P<.001) at follow-up. Dyscognition is predictive of future pain and fatigue in patients with FM. Continued work should examine dyscognition as a clinical predictor of future severity of core symptoms such as pain and fatigue.

Sex Differences in Physical Activity Among Individuals With Type 2 Diabetes Across the Life Span: A Systematic Review and Meta-analysis.

BACKGROUND: Physical activity (PA) is a cornerstone of type 2 diabetes mellitus (T2DM) treatment. Sex differences in PA behavior or barriers/facilitators to PA among individuals with T2DM are unclear. PURPOSE: To summarize the evidence related to sex differences in participation in PA and barriers/facilitators to PA among individuals with T2DM across the life span. DATA SOURCES: Systematic searches (CRD42021254246) were conducted with Ovid MEDLINE, Embase, Web of Science, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Allied and Complementary Medicine Database (AMED), APA PsychInfo, and SPORTDiscus. STUDY SELECTION: We included studies with assessment of PA, sedentary behaviors (SB), or barriers/facilitators to PA among individuals with T2DM by sex or gender. DATA EXTRACTION: Participant characteristics, meeting PA guidelines, participation in PA and SB, and barriers/facilitators to PA were extracted by two independent reviewers. DATA SYNTHESIS: A total of 53 articles (65,344 participants) were included in the systematic review and 21 articles in the meta-analysis. Sex differences were not observed in meeting of PA guidelines among adolescents (odds ratio 0.70 [95% CI 0.31, 1.59]), but males were more likely than females to meet PA guidelines among adults (1.65 [1.36, 2.01]) and older adults (1.63 [1.27, 2.09]). Males performed more moderate-to-vigorous PA (MVPA) than females across all age-groups. Common barriers to PA were lack of time (men) and lack of social support and motivation (women). LIMITATIONS: Limitations include heterogeneity of measures used to assess PA and lack of stratification of data by sex. CONCLUSIONS: Sex differences in meeting PA guidelines were not observed among adolescents but were apparent among adults and older adults with T2DM. Females consistently engaged in less MVPA than males across the life span.