A narrative review of exercise participation among adults with prediabetes or type 2 diabetes: barriers and solutions.

Type 2 diabetes (T2D) has been rising in prevalence over the past few decades in the US and worldwide. T2D contributes to significant morbidity and premature mortality, primarily due to cardiovascular disease (CVD). Exercise is a major cornerstone of therapy for T2D as a result of its positive effects on glycemic control, blood pressure, weight loss and cardiovascular risk as well as other measures of health. However, studies show that a majority of people with T2D do not exercise regularly. The reasons given as to why exercise goals are not met are varied and include physiological, psychological, social, cultural and environmental barriers to exercise. One potential cause of inactivity in people with T2D is impaired cardiorespiratory fitness, even in the absence of clinically evident complications. The exercise impairment, although present in both sexes, is greater in women than men with T2D. Women with T2D also experience greater perceived exertion with exercise than their counterparts without diabetes. These physiological barriers are in addition to constructed societal barriers including cultural expectations of bearing the burden of childrearing for women and in some cultures, having limited access to exercise because of additional cultural expectations. People at risk for and with diabetes more commonly experience unfavorable social determinants of health (SDOH) than people without diabetes, represented by neighborhood deprivation. Neighborhood deprivation measures lack of resources in an area influencing socioeconomic status including many SDOH such as income, housing conditions, living environment, education and employment. Higher indices of neighborhood deprivation have been associated with increased risk of all-cause, cardiovascular and cancer related mortality. Unfavorable SDOH is also associated with obesity and lower levels of physical activity. Ideally regular physical activity should be incorporated into all communities as part of a productive and healthy lifestyle. One potential solution to improve access to physical activity is designing and building environments with increased walkability, greenspace and safe recreational areas. Other potential solutions include the use of continuous glucose monitors as real-time feedback tools aimed to increase motivation for physical activity, counseling aimed at improving self-efficacy towards exercise and even acquiring a dog to increase walking time. In this narrative review, we aim to examine some traditional and novel barriers to exercise, as well as present evidence on novel interventions or solutions to overcome barriers to increase exercise and physical activity in all people with prediabetes and T2D.

Integrating a physical activity coaching intervention into diabetes care: a mixed-methods evaluation of a pilot pragmatic trial.

Physical activity (PA) counseling is under-utilized in primary care for patients with type 2 diabetes mellitus (T2D), despite improving important health outcomes, including physical function. We adapted evidence-based PA counseling programs to primary care patients, staff, and leader's needs, resulting in "Be ACTIVE" comprised of shared PA tracker data (FitBit©), six theory-informed PA coaching calls, and three in-person clinician visits. In a pilot randomized pragmatic trial, we evaluated the feasibility, acceptability, and effectiveness of Be ACTIVE. Sedentary patients with T2D were randomized to Be ACTIVE versus an enhanced control condition. Mixed methods assessments of feasibility and acceptability included costs. Objective pilot effectiveness outcomes included PA (primary outcome, accelerometer steps/week), the Short Physical Performance Battery (SPPB) physical function measure, and behavioral PA predictors. Fifty patients were randomized to Be ACTIVE or control condition. Acceptability was >90% for patients and clinic staff. Coaching and PA tracking costs of ~$90/patient met Medicare reimbursement criteria. Pre-post PA increased by ~11% (Be ACTIVE) and ~6% in controls (group difference: 1574 ± 4391 steps/week, p = .72). As compared to controls, Be ACTIVE participants significantly improved SPPB (0.9 ± 0.3 vs. -0.1 ± 0.3, p = .01, changes >0.5 points prevent falls clinically), and PA predictors of self-efficacy (p = .02) and social-environmental support (p < .01). In this pilot trial, Be ACTIVE was feasible and highly acceptable to stakeholders and yielded significant improvements in objective physical function consistent with lower fall risk, whereas PA changes were less than anticipated. Be ACTIVE may need additional adaptation or a longer duration to improve PA outcomes.

We report results from a pragmatic and behavioral theory-based physical activity (PA) coaching program, termed "Be ACTIVE," for patients with type 2 diabetes that was designed to improve PA and function for patients and to be reimbursable and feasible for primary care teams. As compared to those who did not receive coaching, patients who received Be ACTIVE had physical function improvements that lowered their risk of falls. Be ACTIVE was delivered with fidelity and was highly acceptable to the key primary care stakeholders of patients, clinic staff coaches, and clinicians. Patients particularly liked the focus on setting goals to do enjoyable activities, the accountability of wearing a PA monitor, and the support of their coach. Clinical care professionals felt that their role of encouraging behavior change (coach) and safety monitoring (clinician) aligned well with their clinical expertise, and was professionally rewarding. Coaches felt the program helped them guide many patients to overcome preexisting negative perceptions of PA and develop intrinsic motivations to be active. The costs of clinic coach time and PA tracker rental needed to deliver the 12-week program could be reimbursed by the Medicare Chronic Disease Management programs, albeit with a patient co-payment required.

Connecting the past to the present: A historical review of exercise training for peripheral artery disease.

Peripheral artery disease (PAD), a prevalent manifestation of atherosclerosis, is associated with increased cardiovascular morbidity and mortality as well as decreased functional ability. Exercise training for PAD is acknowledged to be a highly effective treatment, which improves walking ability and cardiovascular risk. The historical development of this treatment has not been the focus of a report. Therefore, we present a historical review of research on exercise training for PAD. Overall, this body of knowledge has provided strong evidence of the efficacy of supervised exercise training (SET) to improve walking ability for patients with claudication due to PAD. SET, using intermittent bouts of walking exercise to moderate claudication pain on a treadmill, is considered the most efficacious mode of exercise to improve walking ability in patients with claudication. This compelling evidence published over the past 60 years was evaluated by the Centers for Medicare & Medicaid Services in 2017, which culminated in a national coverage determination for SET to improve symptomatic PAD. Future directions include determining optimal delivery strategies for SET and further elucidation of the mechanisms of improvement in walking ability resulting from SET. In addition, alternative forms of exercise should be evaluated and effective home- and community-based exercise interventions should be assessed. There is an enormous need to increase the inclusion of women and racial and ethnic minority groups in studies. It is to be hoped that researchers will continue with new innovative research and persistence in the treatment of claudication due to PAD.

From Stigma to Validation: A Qualitative Assessment of a Novel National Program to Improve Retention of Physician-Scientists with Caregiving Responsibilities.

Background: Research is needed to improve understanding of work-life integration issues in academic medicine and to guide the implementation of the Doris Duke Charitable Foundation's Fund to Retain Clinical Scientists (FRCS), a national initiative offering financial support to physician-scientists facing caregiving challenges. Materials and Methods: In 2018, as part of a prospective program evaluation, the authors conducted a qualitative study to examine FRCS program participants' initial impressions, solicit descriptions of their career and caregiving experiences, and inquire how such factors might influence their professional advancement. The authors invited all 33 awardees who had been granted FRCS funding in the first year of the program to participate in the study, of whom 28 agreed to complete an interview. Analysts evaluated de-identified transcripts and explicated the data using a thematic analysis approach. Results: While participants described aspects of a culture that harbor stigma against caregivers and impede satisfactory work-life integration, they also perceived an optimistic cultural shift taking place as a result of programs like the FRCS. Their comments indicated that the FRCS has the potential to influence culture if institutional leadership simultaneously fosters a community that validates individuals both as caregivers and as scientists. Conclusions: Insights garnered from this qualitative study suggest that there is a pressing need for institutional leaders to implement programs that can foster awareness and normalization of caregiving challenges. In addition to providing funding and other tangible resources, interventions should strive to reinforce a broader culture that affirms the presence of work-life integration challenges and openly embraces solutions.

Implementation of Supervised Exercise Therapy for Patients With Symptomatic Peripheral Artery Disease: A Science Advisory From the American Heart Association.

Patients with lower-extremity peripheral artery disease (PAD) have greater functional impairment, faster functional decline, increased rates of mobility loss, and poorer quality of life than people without PAD. Supervised exercise therapy (SET) improves walking ability, overall functional status, and health-related quality of life in patients with symptomatic PAD. In 2017, the Centers for Medicare & Medicaid Services released a National Coverage Determination (CAG-00449N) for SET programs for patients with symptomatic PAD. This advisory provides a practical guide for delivering SET programs to patients with PAD according to Centers for Medicare & Medicaid Services criteria. It summarizes the Centers for Medicare & Medicaid Services process and requirements for referral and coverage of SET and provides guidance on how to implement SET for patients with PAD, including the SET protocol, options for outcome measurement, and transition to home-based exercise. This advisory is based on the guidelines established by the Centers for Medicare & Medicaid Services for Medicare beneficiaries in the United States and is intended to assist clinicians and administrators who are implementing SET programs for patients with PAD.

The Most Valuable Resource Is Time: Insights From a Novel National Program to Improve Retention of Physician-Scientists With Caregiving Responsibilities.

PURPOSE: To enhance understanding of challenges related to work-life integration in academic medicine and to inform the ongoing implementation of an existing program and the development of other interventions to promote success of physician-scientists. METHOD: This study is part of a prospective analysis of the effects of the Fund to Retain Clinical Scientists (FRCS), a national program launched by the Doris Duke Charitable Foundation at 10 U.S. institutions, which provides financial support to physician-scientists facing caregiving challenges. In early 2018, 28 of 33 program awardees participated in semistructured interviews. Questions were about challenges faced by physician-scientists as caregivers and their early perceptions of the FRCS. Multiple analysts reviewed deidentified transcripts, iteratively revised the coding scheme, and interpreted the data using qualitative thematic analysis. RESULTS: Participants' rich descriptions illuminated 5 interconnected themes: (1) Time is a critical and limited resource, (2) timing is key, (3) limited time resources and timing conflicts may have a particularly adverse effect on women's careers, (4) flexible funds enable reclamation and repurposing of time resources, and (5) FRCS leaders should be cognizant of time and timing conflicts when developing program-related offerings. CONCLUSIONS: Programs such as the FRCS are instrumental in supporting individuals to delegate time-consuming tasks and to control how they spend their valuable time. Qualitative analysis suggests that access to and command of valuable time resources are crucial to career advancement, research productivity, and work-life flexibility, especially during critical time points along the physician-scientist trajectory.

Identifying the Critical Gaps in Research on Sex Differences in Metabolism Across the Life Span.

The National Institutes of Health (NIH) Office of Research in Women's Health now functions under a mandate calling for the systematic inclusion of both female and male cells, animals, and human subjects in all types of research, so that sex as a biological variable is understood in health and disease. Sex-specific data can improve disease prevention, diagnosis, and treatment as well as reduce inequities. Inclusion of women in research studies has modestly improved over the last 20 years, yet preclinical research is still primarily done using male animal models and male-derived cells, with the result that many conclusions are made based on incomplete and sex-biased data. There are important, yet poorly studied, sex differences in cardiometabolic disease. To begin to address these sex differences, the Center for Women's Health Research at the University of Colorado held its inaugural National Conference, "Sex Differences Across the Lifespan: A Focus on Metabolism," in September 2016 (cwhr@ucdenver.edu). Research to address the important goal of understanding key sex differences in cardiometabolic disease across the life span is lacking. The goal of this article is to discuss the current state of research addressing sex differences in cardiometabolic health across the life span, to outline critical research gaps that must be addressed in response to NIH mandates, and, importantly, to develop strategies to address sex as a biological variable to understand disease mechanisms as well as develop diagnostic and therapeutic modalities.

Cost-effectiveness of supervised exercise, stenting, and optimal medical care for claudication: results from the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) trial.

BACKGROUND: Both supervised exercise (SE) and stenting (ST) improve functional status, symptoms, and quality of life compared with optimal medical care (OMC) in patients with claudication. The relative cost-effectiveness of these strategies is not well defined. METHODS AND RESULTS: The Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) study randomized patients with claudication due to aortoiliac stenosis to a 6-month SE program, to ST, or to OMC. Participants who completed 6-month follow-up (n=98) were included in a health economic analysis through 18 months. Costs were assessed using resource-based methods and hospital billing data. Quality-adjusted life-years were estimated using the EQ-5D. Markov modeling based on the in-trial results was used to explore the impact of assumptions about the longer term durability of observed differences in quality of life. Through 18 months, mean healthcare costs were $5178, $9804, and $14 590 per patient for OMC, SE, and ST, respectively. Measured quality-adjusted life-years through 18 months were 1.04, 1.16, and 1.20. In our base case analysis, which assumed that observed differences in quality of life would dissipate after 5 years, the incremental cost-effectiveness ratios were $24 070 per quality-adjusted life-year gained for SE versus OMC, $41 376 for ST versus OMC, and $122 600 for ST versus SE. If the treatment effect of ST was assumed to be more durable than that of SE, the incremental cost-effectiveness ratio for ST versus SE became more favorable. CONCLUSIONS: Both SE and ST are economically attractive by US standards relative to OMC for the treatment of claudication in patients with aortoiliac disease. ST is more expensive than SE, with uncertain incremental benefit. CLINICAL TRIAL REGISTRATION URL: www.clinicaltrials.gov, Unique identifier: NCT00132743.

Assessment of functional status and quality of life in claudication.

BACKGROUND: Treadmill walking is commonly used to evaluate walking impairment and efficacy of treatment for intermittent claudication (IC) in clinical and research settings. Although this is an important measure, it does not provide information about how patients perceive the effects of their treatments on more global measures of health-related quality of life (HRQOL). METHODS: PubMed/Medline was searched to find publications about the most commonly used questionnaires to assess functional status and/or general and disease-specific HRQOL in patients with peripheral artery disease (PAD) who experience IC. Inclusion criteria for questionnaires were based on existence of a body of literature in symptomatic PAD. RESULTS: Six general questionnaires and seven disease-specific questionnaires are included, with details about the number of domains covered and how each tool is scored. The Medical Outcomes Study Short Form 36-item questionnaire and Walking Impairment Questionnaire are currently the most used general and disease-specific questionnaires at baseline and after treatment for IC, respectively. CONCLUSIONS: The use of tools that assess functional status and HRQOL has importance in both the clinical and research areas to assess treatment efficacy from the patient's perspective. Therefore, assessing HRQOL in addition to treadmill-measured walking ability provides insight as to the effects of treatments on patient outcomes and may help guide therapy.

Design of the multicenter standardized supervised exercise training intervention for the claudication: exercise vs endoluminal revascularization (CLEVER) study.

The CLaudication: Exercise Vs Endoluminal Revascularization (CLEVER) study is the first randomized, controlled, clinical, multicenter trial that is evaluating a supervised exercise program compared with revascularization procedures to treat claudication. In this report, the methods and dissemination techniques of the supervised exercise training intervention are described. A total of 217 participants are being recruited and randomized to one of three arms: (1) optimal medical care; (2) aortoiliac revascularization with stent; or (3) supervised exercise training. Of the enrolled patients, 84 will receive supervised exercise therapy. Supervised exercise will be administered according to a protocol designed by a central CLEVER exercise training committee based on validated methods previously used in single center randomized control trials. The protocol will be implemented at each site by an exercise committee member using training methods developed and standardized by the exercise training committee. The exercise training committee reviews progress and compliance with the protocol of each participant weekly. In conclusion, a multicenter approach to disseminate the supervised exercise training technique and to evaluate its efficacy, safety and cost-effectiveness for patients with claudication due to peripheral arterial disease (PAD) is being evaluated for the first time in CLEVER. The CLEVER study will further establish the role of supervised exercise training in the treatment of claudication resulting from PAD and provide standardized methods for use of supervised exercise training in future PAD clinical trials as well as in clinical practice.

Claudication: exercise vs endoluminal revascularization (CLEVER) study update.

The Claudication: Exercise vs Endoluminal Revascularization (CLEVER) Study is a prospective multicenter randomized clinical trial designed to compare the relative clinical and cost-effectiveness of invasive revascularization with stents to supervised exercise rehabilitation in a cohort with moderate to severe claudication due to aortoiliac insufficiency. The study is currently enrolling at twenty-eight sites in the US and Canada. Enrollment of 217 participants is planned, with data collected at baseline, six months, and 18 months. The primary study endpoint is maximum walking duration (MWD) on a graded treadmill test; secondary endpoints include community-based walking, markers of cardiovascular disease risk (body mass index, waist circumference, blood pressure, lipid profile, glucose tolerance, and plasma fibrinogen), health-related quality of life, and cost effectiveness. There are currently sixty randomized participants; recruitment is projected to end in July 2010 and final study results reported in June 2012.

The Claudication: Exercise Vs. Endoluminal Revascularization (CLEVER) study: rationale and methods.

Intermittent claudication is the primary symptom of peripheral arterial disease, affecting between 1 and 3 million Americans. Symptomatic improvement can be achieved by endovascular revascularization, but such procedures are invasive, expensive, and may be associated with procedural adverse events. Medical treatment options, including claudication medications and supervised exercise training, are also known to be effective, albeit also with associated limitations. The CLEVER (Claudication: Exercise Vs. Endoluminal Revascularization) study, funded by the Heart, Lung, and Blood Institute of the National Institutes of Health, is a prospective, multicenter, randomized, controlled clinical trial evaluating the relative efficacy, safety, and health economic impact of four treatment strategies for people with aortoiliac peripheral arterial disease and claudication. The treatment arms are: (1) optimal medical care (claudication pharmacotherapy); (2) primary stent placement; (3) supervised exercise rehabilitation; and (4) combined stenting with supervised exercise rehabilitation. The CLEVER study is a 5-year randomized, controlled clinical trial to be conducted at approximately 25 centers in the United States that will monitor 252 patients and their responses to treatment during an 18-month follow-up period. The primary end point is change in maximum walking duration on a graded treadmill test. Secondary end points include the change at 18 months in maximum walking duration from baseline, comparisons of free-living daily activity levels assessed by pedometer, health-related quality of life, and cost-effectiveness. Other analyses include the effect of these treatment strategies on anthropomorphic and physiologic variables, including body mass index, waist circumference, blood pressure, pulse pressure, and resting pulse as well as biochemical markers of cardiovascular health, including fasting lipids, fibrinogen, C-reactive protein, and hemoglobin A 1c values.

The impact of peripheral arterial disease on health-related quality of life in the Peripheral Arterial Disease Awareness, Risk, and Treatment: New Resources for Survival (PARTNERS) Program.

This study tested the hypothesis that patients with PAD have impaired health-related quality of life (HRQoL) to a degree similar to that of patients with other types of cardiovascular disease (other-CVD), and also evaluated the clinical features of PAD associated with impaired HRQoL. This was a cross-sectional study in 350 primary care practice sites nationwide with 6,499 participants. The reference group had no clinical or hemodynamic evidence of PAD or other-CVD; the PAD group had an ankle-brachial index < 0.90 or a prior history of PAD; the other-CVD group had a clinical history of cardiac or cerebral vascular disease (but no PAD), and the combined PAD-other-CVD group included both diagnoses. Individuals were assessed using four HRQoL questionnaires including the Walking Impairment Questionnaire (WIQ), Medical Outcomes Study SF-36 (SF-36), Cantril Ladder of Life and the PAD Quality of Life questionnaire. PAD patients had lower WIQ distance scores than the other-CVD group. Both the PAD and other-CVD groups had significantly lower SF-36 Physical Function scores compared with the reference group. The WIQ revealed that PAD patients were more limited by calf pain, whereas other-CVD patients were more limited by chest pain, shortness of breath and palpitations. In conclusion, in this nationwide study, one of the first to directly compare the HRQoL burden of CVD with that of PAD, the evaluation of PAD in office practice revealed a HRQoL burden as great in magnitude as in patients with other forms of CVD.

Risk assessment in the patient with established peripheral arterial disease.

Office-based cardiovascular risk prediction continues to challenge practitioners in primary and secondary risk stratification settings. In patients with established peripheral arterial disease (PAD), the risk of cardiovascular events (i.e. death or morbidity due to coronary heart disease and/or cerebrovascular disease) is high, yet traditional risk factors and the ankle-brachial index (ABI) do not provide a complete secondary risk prediction. In this population, office-based cardiovascular risk stratification may be improved by surrogate markers of the systemic atherosclerotic burden, as well as markers of systemic inflammation. This review will evaluate the utility of the ABI, clinical stage of disease, and the emerging role of C-reactive protein (CRP) and other inflammatory markers in secondary risk prediction in PAD. Defining which patients are in the highest category of risk may direct health care providers to emphasize secondary preventive measures, and facilitate patient adherence to recommended medical therapies and smoking cessation.

Minor depression and health status among US adults with diabetes mellitus.

OBJECTIVE: To determine whether diabetes mellitus (DM) with minor depression is associated with poorer levels of mental and physical functioning compared with DM without depression. STUDY DESIGN: Retrospective database study. METHODS: US adults participating in the 2001 Medical Expenditure Panel Survey were included in these analyses. Main outcome measures were differences in health status, physical and cognitive limitations, and the Short-Form 12 (SF-12) Mental Component Summary (MCS) and Physical Component Summary (PCS) for US adults with DM stratified by minor depression status and evaluated using univariate and multivariate analyses to control for demographic, behavioral, and clinical covariates. RESULTS: A total of 1572 respondents with DM were included (1443 without depression, 129 with depression). Compared with people with DM and without depression, those with DM and minor depression were younger (P = .04); were more likely to be female, white, and smokers; and to have physical and cognitive limitations and lower SF-12 MCS and PCS scores (all P < .01). In multivariate analyses, minor depression was independently associated with lower self-reported health status, MCS scores, and more cognitive limitations. CONCLUSION: People with DM and minor depression have lower mental functional scores, more cognitive limitations, and lower self-reported health status scores compared with people with DM and without depression, differences that may adversely affect self-care activities. Primary and DM care providers should screen for and be aware of depression in their patients with DM.

Attendance and graduation patterns in a group-model health maintenance organization alternative cardiac rehabilitation program.

PURPOSE: Poor rates of participation in cardiac rehabilitation programs are well documented, especially among women and older patients. The Colorado Kaiser Permanente Cardiac Rehabilitation (KPCR) program is a home-based, case-managed, goal-oriented program with an active recruitment process and unlimited program length. This study evaluated the participation rates for the program and the predictors of attendance and graduation. METHODS: Patients hospitalized with acute myocardial infarction, coronary artery bypass graft, and percutaneous coronary intervention from June 1999 to May 2000 (n = 1030) were identified from the administrative database, and the proportion captured by the KPCR staff was determined. Subsequent attendance and graduation patterns were evaluated. RESULTS: Nearly 94% of patients with one of the three aforementioned conditions were identified by the rehabilitation staff, and 41% of all patients attended the KPCR program. More than 75% of the patients who participated went on to graduate from the program. Gender comparisons showed no difference in participation between men (66.8%) and women (59.7%) (P =.07). Participation rates were inversely associated with age, yet age was not associated with graduation from the program. Surgical interventions and two or more events experienced within the first 4 weeks of the index event were the strongest predictors of attendance and graduation from the KPCR program. CONCLUSIONS: Innovative approaches for the capture and retention of patients in cardiac rehabilitation programs are urgently needed. The alternative program evaluated in this study showed little difference in participation between men and women, yet participation among older patients remained poor. Overall, patients who underwent surgical interventions or multiple events were more likely to attend and graduate from the program.