Overcoming Pandemic-Related Challenges in Recruitment and Screening: Strategies and Representation of Older Women With Cardiovascular Disease for a Multidomain Lifestyle Trial to Prevent Cognitive Decline.

BACKGROUND: Recruiting participants with cardiovascular disease into research during the COVID-19 pandemic was challenging, particularly those at risk of health disparities. OBJECTIVE: During the pandemic, 12 cohorts of older women with cardiovascular disease were recruited from cardiology clinics into a lifestyle intervention trial to prevent cognitive decline. Objectives were to (a) describe the results of modified recruitment/screening strategies to overcome pandemic-related challenges and (b) evaluate differences in age, race, and ethnicity between patients recruited/randomized, recruited/not randomized (entered recruitment but not randomized because of being ineligible or not interested), and not recruited (clinic patients who met preliminary criteria but did not enter recruitment). METHODS: This was a cross-sectional descriptive analysis. In-person study strategies proposed before the COVID-19 pandemic were modified before study onset (September 2020). Women 65 years or older with cardiovascular disease were recruited from cardiology clinics by clinicians, posted flyers, and letters mailed to patients randomly selected from electronic health record data extractions. Patients were classified as recruited/randomized, recruited/not randomized, and not recruited. RESULTS: Of 5719 patients potentially eligible, 1689 patients entered recruitment via referral (49.1%), posted flyers (0.5%), or mailed letters (50.3%), and 253 patients were successfully recruited/randomized. Recruited/randomized participants were, on average, 72.4 years old (range, 65-90 years old), non-Hispanic White (54.2%), non-Hispanic Black (38.3%), Hispanic/Latinx (1.6%), and other/not reported (5.1%). The recruited/randomized group was significantly younger with fewer patients of Hispanic/Latinx ethnicity compared with those not recruited. CONCLUSIONS: During the pandemic, all recruitment/screening goals were met using modified strategies. Differences in sociodemographic representation indicate a need for tailored strategies.

Effects of the COVID-19 pandemic on recruitment for the working women walking program.

The global pandemic of coronavirus disease 2019 (COVID-19) affected many aspects of randomized controlled trials, including recruiting and screening participants. The purpose of this paper is to (a) describe adjustments to recruitment and screening due to COVID-19, (b) compare the proportional recruitment outcomes (not completed, ineligible, and eligible) at three screening stages (telephone, health assessment, and physical activity assessment) pre- and post-COVID-19 onset, and (c) compare baseline demographic characteristics pre- and post-COVID-19 onset in the Working Women Walking program. The design is a cross-sectional descriptive analysis of recruitment and screening data from a 52-week sequential multiple assignment randomized trial (SMART). Participants were women 18-70 years employed at a large urban medical center. Recruitment strategies shifted from in-person and electronic to electronic only post-COVID-19 onset. In-person eligibility screening for health and physical activity assessments continued post-COVID-19 onset with Centers for Disease Control and Prevention precautions. Of those who expressed interest in the study pre- and post-COVID-19 onset (n = 485 & n = 269 respectively), 40% (n = 194) met all eligibility criteria pre-COVID-19 onset, and 45.7% (n = 123) post-COVID-19 onset. Although there were differences in the proportions of participants who completed or were eligible for some of the screening stages, the final eligibility rates did not differ significantly pre-COVID-19 versus post-COVID-19 onset. Examination of differences in participant demographics between pre- and post-COVID-19 onset revealed a significant decrease in the percentage of Black women recruited into the study from pre- to post-COVID-19 onset. Studies recruiting participants into physical activity studies should explore the impact of historical factors on recruitment.

The MindMoves Trial: Cross-Sectional Analyses of Baseline Vascular Risk and Cognition in Older Women with Cardiovascular Disease.

Background: Vascular diseases, including atherosclerotic cardiovascular disease (ASCVD) and stroke, increase the risk of Alzheimer's disease and cognitive impairment. Serum biomarkers, such as brain-derived neurotrophic factor (BDNF), vascular endothelial growth factor (VEGF), and insulin-like growth factor 1 (IGF-1), may be indicators of cognitive health. Objective: We examined whether vascular risk was associated with levels of cognition and serum biomarkers in older women with cardiovascular disease (CVD). Methods: Baseline data from a lifestyle trial in older women (n = 253) with CVD (NCT04556305) were analyzed. Vascular risk scores were calculated for ASCVD (ASCVD risk estimator) and stroke (CHA2DS2-VASc) based on published criteria. Cognition-related serum biomarkers included BDNF, VEGF, and IGF-1. Cognition was based on a battery of neuropsychological tests that assessed episodic memory, semantic memory, working memory, and executive function. A series of separate linear regression models were used to evaluate associations of vascular risk scores with outcomes of cognition and serum biomarkers. All models were adjusted for age, education level, and racial and ethnic background. Results: In separate linear regression models, both ASCVD and CHA2DS2-VASc scores were inversely associated with semantic memory (ß= -0.22, p = 0.007 and ß= -0.15, p = 0.022, respectively), with no significant findings for the other cognitive domains. There were no significant associations between vascular risk scores and serum biomarkers. Conclusions: Future studies should prospectively examine associations between vascular risk and cognition in other populations and additionally consider other serum biomarkers that may be related to vascular risk and cognition.

Therapy for insomnia with chronic obstructive pulmonary disease: a randomized trial of components.

STUDY OBJECTIVES: To determine efficacy and mechanisms of cognitive behavioral therapy for insomnia (CBT-I) and chronic obstructive pulmonary disease (COPD) education (COPD-ED) on clinical outcomes in adults with concurrent COPD and insomnia. METHODS: We conducted a 2 × 2 factorial study to test the impact of CBT-I and COPD-ED delivered alone or in combination on severity of insomnia and fatigue, sleep, and dyspnea. Participants were randomized to 1 of 4 groups-group 1: CBT-I + attention control (AC; health videos, n = 27); group 2: COPD-ED + AC, n = 28; group 3: CBT-I + COPD-ED, n = 27; and group 4, AC only, n = 27. Participants received six 75-minute weekly sessions. Dependent variables included insomnia severity, sleep by actigraphy, fatigue, and dyspnea measured at baseline, immediately postintervention, and at 3 months postintervention. Presumed mediators of intervention effects included beliefs and attitudes about sleep, self-efficacy for sleep and COPD, and emotional function. RESULTS: COPD patients (percent predicted forced expiratory volume in 1 second [FEV1pp] 67% ± 24% [mean ± standard deviation]), aged 65 ± 8 years, with insomnia participated in the study. Insomnia and sleep improved more in patients who received CBT-I than in those who did not, an effect that was sustained at 3 months postintervention and mediated by beliefs and attitudes about sleep. CBT-I was associated with clinically important improvements in fatigue and dyspnea. When CBT-I and COPD-ED were concurrently administered, effects on insomnia, fatigue, and dyspnea were attenuated. CONCLUSIONS: CBT-I produced significant and sustained decreases in insomnia improved sleep and clinically important improvement in fatigue, and dyspnea. The combination of CBT-I and COPD-ED reduced CBT-I's effectiveness. Further research is needed to understand the mechanisms associated with effects of insomnia therapy on multiple symptoms in COPD. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: A Behavioral Therapy for Insomnia Co-existing with COPD; URL: https://clinicaltrials.gov/ct2/show/NCT01973647; Identifier: NCT01973647. CITATION: Kapella M, Steffen A, Prasad B, et al. Therapy for insomnia with chronic obstructive pulmonary disease: a randomized trial of components. J Clin Sleep Med. 2022;18(12):2763-2774.

The effect of abdominal exercise on abdominal fat.

The purpose of this study was to investigate the effect of abdominal exercises on abdominal fat. Twenty-four healthy, sedentary participants (14 men and 10 women), between 18 and 40 years, were randomly assigned to 1 of the following 2 groups: control group (CG) or abdominal exercise group (AG). Anthropometrics, body composition, and abdominal muscular endurance were tested before and after training. The AG performed 7 abdominal exercises, for 2 sets of 10 repetitions, on 5 d·wk(-1) for 6 weeks. The CG received no intervention, and all participants maintained an isocaloric diet throughout the study. Significance was set at p = 0.05 for all tests. There was no significant effect of abdominal exercises on body weight, body fat percentage, android fat percentage, android fat, abdominal circumference, abdominal skinfold and suprailiac skinfold measurements. The AG performed significantly greater amount of curl-up repetitions (47 ± 13) compared to the CG (32 ± 9) on the posttest. Six weeks of abdominal exercise training alone was not sufficient to reduce abdominal subcutaneous fat and other measures of body composition. Nevertheless, abdominal exercise training significantly improved muscular endurance to a greater extent than the CG.

Study protocol for a sequential multiple assignment randomized trial (SMART) to improve physical activity in employed women.

INTRODUCTION: Physical activity monitors, motivational text messages, personal calls, and group meetings, have proven to be efficacious physical activity interventions. However, individual participant response to these interventions varies drastically. A SMART design (sequential multiple assignment randomized trial) provides an effective way to test interventions that start with an initial treatment and then transition to an augmented treatment for non-responders. We describe a SMART to determine the most effective adaptive intervention to increase physical activity (steps, moderate-to-vigorous physical activity) and improve cardiovascular health among employed women who are not regularly physically active. The SMART uses combinations of four treatments: 1) enhanced physical activity monitor (Fitbit wearable activity monitor and mobile app with goal setting and physical activity prescription), 2) text messages, 3) personal calls, and 4) group meetings. METHODS: Participants (N = 312) include women ages 18-70 employed at a large academic medical center. Women will be randomized to an initial intervention, either an enhanced physical activity monitor or enhanced physical activity monitor + text messaging. Non-responders to the initial intervention at 2 months will be randomized to either personal calls or groups meetings for the next 6 months. At 8 months, all participants will return to only an enhanced physical activity monitor until their final 12-month assessment. DISCUSSION: Results of this study will add to the literature on improving physical activity in employed women. This study will identify effective interventions for women who respond to less intensive treatments, while maximizing benefits for those who need a more intensive approach.

Actigraphy scoring for sleep outcome measures in chronic obstructive pulmonary disease.

BACKGROUND: Actigraphy is commonly used to measure sleep outcomes so that sleep can be measured conveniently at home over multiple nights. Actigraphy has been validated in people with sleep disturbances; however, the validity of scoring settings in people with chronic medical illnesses such as chronic obstructive pulmonary disease remains unclear. The purpose of this secondary analysis was to compare actigraphy-customized scoring settings with polysomnography (PSG) for the measurement of sleep outcomes in people with chronic obstructive pulmonary disease who have insomnia. METHODS: Participants underwent overnight sleep assessment simultaneously by PSG and actigraphy at the University of Illinois of Chicago Sleep Science Center. Fifty participants (35 men and 15 women) with mild-to-severe chronic obstructive pulmonary disease and co-existing insomnia were included in the analysis. Sleep onset latency, total sleep time (TST), wake after sleep onset (WASO), and sleep efficiency (SE) were calculated independently from data derived from PSG and actigraphy. Actigraphy sleep outcome scores obtained at the default setting and several customized actigraphy settings were compared to the scored PSG results. RESULTS: Although no single setting was optimal for all sleep outcomes, the combination of 10 consecutive immobile minutes for sleep onset or end and an activity threshold of 10 worked well. Actigraphy overestimated TST and SE and underestimated WASO, but there was no difference in variance between PSG and actigraphy in TST and SE when the 10 × 10 combination was used. As the average TST and SE increased, the agreement between PSG and actigraphy appeared to increase, and as the average WASO decreased, the agreement between PSG and actigraphy appeared to increase. CONCLUSION: Results support the conclusion that the default actigraphy settings may not be optimal for people with chronic obstructive pulmonary disease and co-existing insomnia.

Health-related stigma as a determinant of functioning in young adults with narcolepsy.

Symptoms of narcolepsy tend to arise during adolescence or young adulthood, a formative time in human development during which people are usually completing their education and launching a career. Little is known about the impact of narcolepsy on the social aspects of health-related quality of life in young adults. The purpose of this study was to examine relationships between health-related stigma, mood (anxiety and depression) and daytime functioning in young adults with narcolepsy compared to those without narcolepsy. Young adults (age 18-35) with narcolepsy (N = 122) and without narcolepsy (N = 93) were mailed a packet that included questionnaires and a self-addressed postage paid envelope. The questionnaire included demographic information and a composite of instruments including the SF 36, Functional Outcomes of Sleep Questionnaire (FOSQ), Fife Stigma Scale (FSS), Epworth Sleepiness Scale (ESS) and Hospital Anxiety and Depression Scale (HADS). Variable associations were assessed using descriptive statistics, ANOVA, Mann-Whitney U Test, correlations, stepwise multiple regression and path analysis. Young adults with narcolepsy perceived significantly more stigma and lower mood and health-related quality of life than young adults without narcolepsy (p<0.01). Health-related stigma was directly and indirectly associated with lower functioning through depressed mood. Fifty-two percent of the variance in functioning was explained by the final model in the young adults with narcolepsy. Health-related stigma in young adults with narcolepsy is at a level consistent with other chronic medical illnesses. Health-related stigma may be an important determinant of functioning in young adults with narcolepsy. Future work is indicated toward further characterizing stigma and developing interventions that address various domains of stigma in people with narcolepsy.