Rationale and Design of the mTECH-Rehab Randomized Controlled Trial: Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program on Functional Status and Cardiovascular Health.

BACKGROUND: Cardiac rehabilitation (CR) is an evidence-based, guideline-recommended intervention for patients recovering from a cardiac event, surgery or procedure that improves morbidity, mortality, and functional status. CR is traditionally provided in-center, which limits access and engagement, most notably among underrepresented racial and ethnic groups due to barriers including cost, scheduling, and transportation access. This study is designed to evaluate the Corrie Hybrid CR, a technology-based, multicomponent health equity-focused intervention as an alternative to traditional in-center CR among patients recovering from a cardiac event, surgery, or procedure compared with usual care alone. METHODS: The mTECH-Rehab (Impact of a Mobile Technology Enabled Corrie CR Program) trial will randomize 200 patients who either have diagnosis of myocardial infarction or who undergo coronary artery bypass grafting surgery, percutaneous coronary intervention, heart valve repair, or replacement presenting to 4 hospitals in a large academic health system in Maryland, United States, to the Corrie Hybrid CR program combined with usual care CR (intervention group) or usual care CR alone (control group) in a parallel arm, randomized controlled trial. The Corrie Hybrid CR program leverages 5 components: (1) a patient-facing mobile application that encourages behavior change, patient empowerment, and engagement with guideline-directed therapy; (2) Food and Drug Administration-approved smart devices that collect health metrics; (3) 2 upfront in-center CR sessions to facilitate personalization, self-efficacy, and evaluation for the safety of home exercise, followed by a combination of in-center and home-based sessions per participant preference; (4) a clinician dashboard to track health data; and (5) weekly virtual coaching sessions delivered over 12 weeks for education, encouragement, and risk factor modification. The primary outcome is the mean difference between the intervention versus control groups in distance walked on the 6-minute walk test (ie, functional capacity) at 12 weeks post randomization. Key secondary and exploratory outcomes include improvement in a composite cardiovascular health metric, CR engagement, quality of life, health factors (including low-density lipoprotein-cholesterol, hemoglobin A1c, weight, diet, smoking cessation, blood pressure), and psychosocial factors. Approval for the study was granted by the local institutional review board. Results of the trial will be published once data collection and analysis have been completed. CONCLUSIONS: The Corrie Hybrid CR program has the potential to improve functional status, cardiovascular health, and CR engagement and advance equity in access to cardiac rehabilitation. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05238103.

An evaluation of cardiopulmonary endurance and muscular strength in adults living with sickle cell disease.

There have been limited investigations into exercise in sickle cell disease (SCD). In the general population, health is reflected in general physical fitness. It is unclear if the same associations are seen in people with SCD. Here, we report a cross-sectional assessment of two important measures of physical fitness, muscle strength and cardiorespiratory endurance, in adults with SCD. A total of 29 adults with SCD (aged 24-62 years; 72% female) completed cardiopulmonary and muscular strength testing using a cycle ergometer and an isokinetic dynamometer. Adults with SCD had lower median values for cardiorespiratory endurance (the median [interquartile range, IQR] peak oxygen uptake [VO2 ] 16.1 [6.3] vs. 42.65 [11.3] ml/kg/min, p < 0.001) and knee strength (median [IQR] flexor torque 26.91[22.5] vs. 55.6 [22.7] Nm, p < 0.001) compared to controls and predicted values. Interestingly, there was a very positive association between muscular strength and peak VO2 values for adults with SCD (r = 0.53, p = 0.003) suggesting these values may be useful in determining cardiopulmonary health.

Depth of sedation as an interventional target to reduce postoperative delirium: mortality and functional outcomes of the Strategy to Reduce the Incidence of Postoperative Delirium in Elderly Patients randomised clinical trial.

BACKGROUND: The Strategy to Reduce the Incidence of Postoperative Delirium in the Elderly trial tested the hypothesis that limiting sedation during spinal anaesthesia decreases in-hospital postoperative delirium after hip fracture repair. This manuscript reports the secondary outcomes of this trial, including mortality and function. METHODS: Two hundred patients (≥65 yr) undergoing hip fracture repair with spinal anaesthesia were randomised to heavier [modified Observer's Assessment of Alertness/Sedation score (OAA/S) 0-2] or lighter (OAA/S 3-5) sedation, and were assessed for postoperative delirium. Secondary outcomes included mortality and return to pre-fracture ambulation level at 1 yr. Kaplan-Meier analysis, multivariable Cox proportional hazard model, and logistic regression were used to evaluate intervention effects on mortality and odds of ambulation return. RESULTS: One-year mortality was 14% in both groups (log rank P=0.96). Independent risk factors for 1-yr mortality included: Charlson comorbidity index [hazard ratio (HR)=1.23, 95% confidence interval (CI), 1.02-1.49; P=0.03], instrumental activities of daily living [HR=0.74, 95% CI, 0.60-0.91; P=0.005], BMI [HR=0.91, 95% CI 0.84-0.998; P=0.04], and delirium severity [HR=1.20, 95% CI, 1.03-1.41; P=0.02]. Ambulation returned to pre-fracture levels, worsened, or was not obtained in 64%, 30%, and 6% of 1 yr survivors, respectively. Lighter sedation did not improve odds of ambulation return at 1 yr [odds ratio (OR)=0.76, 95% CI, 0.24-2.4; P=0.63]. Independent risk factors for ambulation return included Charlson comorbidity index [OR=0.71, 95% CI, 0.53-0.97; P=0.03] and delirium [OR=0.32, 95% CI, 0.10-0.97; P=0.04]. CONCLUSIONS: This study found that in elderly patients having hip fracture surgery with spinal anaesthesia supplemented with propofol sedation, heavier intraoperative sedation was not associated with significant differences in mortality or return to pre-fracture ambulation up to 1 yr after surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT00590707.

Effect of Depth of Sedation in Older Patients Undergoing Hip Fracture Repair on Postoperative Delirium: The STRIDE Randomized Clinical Trial.

Importance: Postoperative delirium is the most common complication following major surgery in older patients. Intraoperative sedation levels are a possible modifiable risk factor for postoperative delirium. Objective: To determine whether limiting sedation levels during spinal anesthesia reduces incident delirium overall. Design, Setting, and Participants: This double-blind randomized clinical trial (A Strategy to Reduce the Incidence of Postoperative Delirum in Elderly Patients [STRIDE]) was conducted from November 18, 2011, to May 19, 2016, at a single academic medical center and included a consecutive sample of older patients (≥65 years) who were undergoing nonelective hip fracture repair with spinal anesthesia and propofol sedation. Patients were excluded for preoperative delirium or severe dementia. Of 538 hip fractures screened, 225 patients (41.8%) were eligible, 10 (1.9%) declined participation, 15 (2.8%) became ineligible between the time of consent and surgery, and 200 (37.2%) were randomized. The follow-up included postoperative days 1 to 5 or until hospital discharge. Interventions: Heavier (modified observer's assessment of sedation score of 0-2) or lighter (observer's assessment of sedation score of 3-5) propofol sedation levels intraoperatively. Main Outcomes and Measures: Delirium on postoperative days 1 to 5 or until hospital discharge determined via consensus panel using Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition, Text Revision) criteria. The incidence of delirium was compared between intervention groups with and without stratification by the Charlson comorbidity index (CCI). Results: Of 200 participants, the mean (SD) age was 82 (8) years, 146 (73%) were women, 194 (97%) were white, and the mean (SD) CCI was 1.5 (1.8). One hundred participants each were randomized to receive lighter sedation levels or heavier sedation levels. A good separation of intraoperative sedation levels was confirmed by multiple indices. The overall incident delirium risk was 36.5% (n = 73) and 39% (n = 39) vs 34% (n = 34) in heavier and lighter sedation groups, respectively (P = .46). Intention-to-treat analyses indicated no statistically significant difference between groups in the risk of incident delirium (log-rank test χ2, 0.46; P = .46). However, in a prespecified subgroup analysis, when stratified by CCI, sedation levels did effect the delirium risk (P for interaction = .04); in low comorbid states (CCI = 0), heavier vs lighter sedation levels doubled the risk of delirium (hazard ratio, 2.3; 95% CI, 1.1- 4.9). The level of sedation did not affect delirium risk with a CCI of more than 0. Conclusions and Relevance: In the primary analysis, limiting the level of sedation provided no significant benefit in reducing incident delirium. However, in a prespecified subgroup analysis, lighter sedation levels benefitted reducing postoperative delirium for persons with a CCI of 0. Trial Registration: clinicaltrials.gov Identifier: NCT00590707.

Lifestyle Intervention for Sleep Disturbances Among Overweight or Obese Individuals.

Little is known about the effect of different lifestyle interventions on sleep disturbances among sedentary obese or overweight persons. We randomized men and women aged 35-65 to 6 months of a weight loss diet (D); or D combined with supervised exercise training D + E. Measurements were self-reported sleep disturbances, the Profile of Mood States questionnaire, BMI, total abdominal subcutaneous and visceral fat by magnetic resonance imaging, and aerobic fitness expressed as VO2peak. The groups did not differ in changes for body weight, abdominal total fat, VO2peak, and sleep disturbances. The novel finding herein is that reduced abdominal subcutaneous fat and depressive symptoms, with either D or D + E were associated with less sleep disturbances.

Lean Mass and Fat Mass as Contributors to Physical Fitness in an Overweight and Obese African American Population.

OBJECTIVE: To determine the association of lean vs fat mass with fitness in healthy, overweight and obese African Americans from families with early-onset coronary disease. DESIGN: Cross-sectional study. SETTING: Baltimore, Maryland. PARTICIPANTS: 191 healthy, overweight, sedentary African Americans (69% women; aged 44.8 ± 11 years; body mass index 34 ± 5 kg/m2). MAIN OUTCOME MEASURES: Anthropometrics, smoking, blood pressure, lipids, c-reactive protein, and glucose were assessed with standard methods; body composition was determined by dual energy X-ray absorptiometry; cardiorespiratory fitness was expressed as VO(2peak) attained during a maximal treadmill test. RESULTS: In both men and women, greater lean mass was independently associated with higher VO(2peak) (P < .05) and explained > 21% of the variance in VO(2peak), adjusted for body mass index, fat mass, important covariables, and nonindependence of families. CONCLUSIONS: In this cross-sectional study, lean mass was the key determinant of cardiorespiratory fitness, independent of sex, age, and magnitude of obesity. These data provide a strong rationale for examining whether interventions that increase lean mass may also improve fitness, even among high-risk overweight and obese African Americans.

Impact of a home-based walking intervention on outcomes of sleep quality, emotional distress, and fatigue in patients undergoing treatment for solid tumors.

Exercise use among patients with cancer has been shown to have many benefits and few notable risks. The purpose of this study was to evaluate the impact of a home-based walking intervention during cancer treatment on sleep quality, emotional distress, and fatigue. Methods. A total of 138 patients with prostate (55.6%), breast (32.5%), and other solid tumors (11.9%) were randomized to a home-based walking intervention or usual care. Exercise dose was assessed using a five-item subscale of the Cooper Aerobics Center Longitudinal Study Physical Activity Questionnaire. Primary outcomes of sleep quality, distress, and fatigue were compared between the two study arms. Results. The exercise group (n = 68) reported more vigor (p = .03) than control group participants (n = 58). In dose response models, greater participation in aerobic exercise was associated with 11% less fatigue (p < .001), 7.5% more vigor (p = .001), and 3% less emotional distress (p = .03), after controlling for intervention group assignment, age, and baseline exercise and fatigue levels. Conclusion. Patients who exercised during cancer treatment experienced less emotional distress than those who were less active. Increasing exercise was also associated with less fatigue and more vigor. Home-based walking is a simple, sustainable strategy that may be helpful in improving a number of symptoms encountered by patients undergoing active treatment for cancer.

Body composition after bone marrow transplantation in childhood.

PURPOSE/OBJECTIVES: To describe the body composition and fat distribution of childhood bone marrow transplantation (BMT) survivors at least one year post-transplantation and examine the ability of the Centers for Disease Control and Prevention criteria to identify survivors with elevated body fat percentage. DESIGN: Cross-sectional, descriptive. SETTING: Pediatric oncology program at a National Cancer Institute-designated comprehensive cancer center. SAMPLE: 48 childhood BMT survivors (27 males and 21 females). METHODS: Measurements included dual-energy x-ray absorptiometry scan, height, weight, and physical activity. Descriptive statistics were reported and mixed-model linear regression models were used to describe findings and associations. MAIN RESEARCH VARIABLES: Total body fat percentage and central obesity (defined as a ratio of central to peripheral fat of 1 or greater). FINDINGS: Fifty-four percent of survivors had body fat percentages that exceeded recommendations for healthy body composition and 31% qualified as having central obesity. Previous treatment with total body irradiation was associated with higher body fat percentage and central obesity, and graft-versus-host disease was associated with lower body fat percentage. The body mass index (BMI) criteria did not correctly identify the BMT survivors who had elevated body fat percentage. CONCLUSIONS: Survivors of childhood BMT are at risk for obesity and central obesity that is not readily identified with standard BMI criteria. IMPLICATIONS FOR NURSING: Nurses caring for BMT survivors should include evaluation of general and central obesity in their assessments. Patient education materials and resources for healthy weight and muscle building should be made available to survivors. Research is needed to develop appropriate interventions.

Bone mineral density after bone marrow transplantation in childhood: measurement and associations.

UNLABELLED: This study examined the bone mineral density (BMD) of 46 (median age 16.3, 8-29) survivors of autologous and allogeneic bone marrow transplantation (BMT). Areal (g/m2) BMD was acquired with dual energy x-ray absorptiometry and volumetric (g/cm3) BMD values were calculated. Abnormal BMD was identified in 24% (11/46) of survivors with areal measures and 22% (10/46) with volumetric measures. Comparison of areal and volumetric BMD revealed the measures were highly correlated (r = 0.73, p<0.001) but clinical diagnosis of osteopenia/osteoporosis were not consistent. Volumetric z-scores were higher for 7/8 of the survivors who were < 3rd percentile for height. Associations of BMD and body composition and disease and treatment factors were assessed with multiple linear regression. When controlling for other significant associations and cumulative steroid dose, the body composition measure of fat mass index (FMI) was associated with higher volumetric BMD z-scores (CI: 0.006, 0.193; p = 0.037). CNS irradiation (CI: -1.710,-0.200; p = 0.015), age at time of testing (CI: -0.116, -0.024; p = 0.004) and female sex (CI: -1.375, -0.155; p = 0.015) were associated with lower volumetric BMD z-scores. CONCLUSIONS: Childhood BMT survivors are at risk for diminished BMD. Areal and volumetric DEXA derived measures of BMD are highly correlated and volumetric measures may correct for underestimation of BMD in BMT survivors who are small for age. Survivors who received CNS irradiation, are older and female may be at greater risk for diminished BMD while fat mass is associated with higher BMD in childhood BMT survivors.

Resistance exercise in individuals with and without cardiovascular disease: 2007 update: a scientific statement from the American Heart Association Council on Clinical Cardiology and Council on Nutrition, Physical Activity, and Metabolism.

Prescribed and supervised resistance training (RT) enhances muscular strength and endurance, functional capacity and independence, and quality of life while reducing disability in persons with and without cardiovascular disease. These benefits have made RT an accepted component of programs for health and fitness. The American Heart Association recommendations describing the rationale for participation in and considerations for prescribing RT were published in 2000. This update provides current information regarding the (1) health benefits of RT, (2) impact of RT on the cardiovascular system structure and function, (3) role of RT in modifying cardiovascular disease risk factors, (4) benefits in selected populations, (5) process of medical evaluation for participation in RT, and (6) prescriptive methods. The purpose of this update is to provide clinicians with recommendations to facilitate the use of this valuable modality.