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Sleep, Stress, and Symptoms Among People With Heart Failure During the COVID-19 Pandemic.
O'Connell, M, Jeon, S, Conley, S, Linsky, S, Redeker, NS
The Journal of cardiovascular nursing. 202301;38(2):E55-E60
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COVID-19 pandemic raised concerns about the effects of stress on mental health and sleep deficiency. Cognitive behavioural therapy for insomnia (CBT-I) has been shown to improve sleep quality and insomnia severity, as well as anxiety and depression, and may be protective during times of stress, including the COVID-19 pandemic. The aim of this study was to examine changes in sleep, sleep-related cognitions, stress, anxiety, and depression among people with heart failure (HF). This study was a randomised controlled trial of the effects of CBT-I compared with HF self-management education (attention-control condition), the “HeartSleep Study.” Results showed that improvements in insomnia severity, sleep quality, latency, and efficiency, sleep-related cognitions and stress, anxiety, and depression after participation in CBT-I or an HF self-management class were sustained during the pandemic. Authors conclude that their findings confirm the clinical benefits of CBT-I for people with HF and comorbidities and also suggest the potential benefits of HF self-management education.
Abstract
BACKGROUND The COVID-19 pandemic raised concerns about the effects of stress on sleep and mental health, particularly among people with chronic conditions, including people with heart failure (HF). OBJECTIVE The aim of this study was to examine changes in sleep, sleep-related cognitions, stress, anxiety, and depression among people with HF who participated in a randomized controlled trial of cognitive behavioral therapy for insomnia before the COVID-19 pandemic. METHODS Participants self-reported sleep characteristics, symptoms, mood, and stress at baseline, 6 months after cognitive behavioral therapy for insomnia or HF self-management education (attention control), and during the pandemic. RESULTS The sample included 112 participants (mean age, 63 ± 12.9 years; 47% women; 13% Black; 68% New York Heart Association class II or III). Statistically significant improvements in sleep, stress, mood, and symptoms that occurred 6 months post treatment were sustained during the pandemic. CONCLUSIONS Improving sleep and symptoms among people with HF may improve coping during stressful events, and cognitive behavioral therapy for insomnia may be protective.
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Impact of fospropofol disodium on lipid metabolism and inflammatory response in patients with hyperlipidemia: a randomized trial.
Yang, C, Chai, TB, Yao, XZ, Zhang, L, Qin, WM, Liang, H, He, QZ, Zhao, ZY
BMC anesthesiology. 2025;(1):99
Abstract
OBJECTIVE This study aims to assess the impact of intravenous infusion of fospropofol disodium on lipid metabolism and the inflammatory response in individuals with hyperlipidemia. METHODS A total of 360 preoperative individuals with hyperlipidemia were selected and randomly assigned to either the treatment group or the control group, with 180 participants in each group. The treatment group received an induction dose of fospropofol disodium at 10 mg/kg intravenously, followed by maintenance at a rate of 10 mg/(kg·h). The control group was administered propofol intravenously at 2 mg/kg for induction and maintained at 4 mg/(kg·h). All other medications were consistent between the two groups. Blood samples (3 ml of venous blood) were collected from patients at four-time points: 1 day before surgery (T0), 3 h after anesthesia induction (T1), 4 h post-surgery (T2), and 24 h post-surgery (T3), to measure levels of triglycerides (TG), cholesterol (CHOL), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein A1 (ApoA1), and apolipoprotein B (ApoB). C-reactive protein (CRP) and interleukin-6 (IL-6) levels were assessed at T0 and T3. Sedation onset time and adverse reactions were recorded for both groups. RESULTS At T0, the control group exhibited increased TG, CHOL, LDL-C, ApoB, and the ApoB/ApoA1 ratio, while the ApoA1 level had decreased. The LDL-C level and the ApoB/ApoA1 ratio showed significant increases (P < 0.01). Both groups showed elevated CRP and IL-6 levels at T3 (P < 0.01). Compared to the control group, the treatment group demonstrated reduced levels of TG, CHOL, LDL-C, ApoB, and the ApoB/ApoA1 ratio at T1-T3, while ApoA1 levels were higher at T1-T2 (P < 0.01 or P < 0.05). The sedation onset time was notably longer in the treatment group, and the incidence of injection-related pain, respiratory depression, hypotension, and other adverse reactions was significantly lower (P < 0.01). CONCLUSION Compared with propofol, intravenous infusion of fospropofol disodium for more than 3 h during anesthesia has lesser impact on lipid metabolism in patients with hyperlipidemia and does not increase inflammatory factors levels.
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Disease Activity and Therapeutic Response to Pegcetacoplan for Geographic Atrophy Identified by Deep Learning-Based Analysis of OCT.
Schmidt-Erfurth, U, Mai, J, Reiter, GS, Riedl, S, Vogl, WD, Sadeghipour, A, McKeown, A, Foos, E, Scheibler, L, Bogunovic, H
Ophthalmology. 2025;(2):181-193
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Abstract
PURPOSE To quantify morphological changes of the photoreceptors (PRs) and retinal pigment epithelium (RPE) layers under pegcetacoplan therapy in geographic atrophy (GA) using deep learning-based analysis of OCT images. DESIGN Post hoc longitudinal image analysis. PARTICIPANTS Patients with GA due to age-related macular degeneration from 2 prospective randomized phase III clinical trials (OAKS and DERBY). METHODS Deep learning-based segmentation of RPE loss and PR degeneration, defined as loss of the ellipsoid zone (EZ) layer on OCT, over 24 months. MAIN OUTCOME MEASURES Change in the mean area of RPE loss and EZ loss over time in the pooled sham arms and the pegcetacoplan monthly (PM)/pegcetacoplan every other month (PEOM) treatment arms. RESULTS A total of 897 eyes of 897 patients were included. There was a therapeutic reduction of RPE loss growth by 22% and 20% in OAKS and 27% and 21% in DERBY for PM and PEOM compared with sham, respectively, at 24 months. The reduction on the EZ level was significantly higher with 53% and 46% in OAKS and 47% and 46% in DERBY for PM and PEOM compared with sham at 24 months. The baseline EZ-RPE difference had an impact on disease activity and therapeutic response. The therapeutic benefit for RPE loss increased with larger EZ-RPE difference quartiles from 21.9%, 23.1%, and 23.9% to 33.6% for PM versus sham (all P < 0.01) and from 13.6% (P = 0.11), 23.8%, and 23.8% to 20.0% for PEOM versus sham (P < 0.01) in quartiles 1, 2, 3, and 4, respectively, at 24 months. The therapeutic reduction of EZ loss increased from 14.8% (P = 0.09), 33.3%, and 46.6% to 77.8% (P < 0.0001) between PM and sham and from 15.9% (P = 0.08), 33.8%, and 52.0% to 64.9% (P < 0.0001) between PEOM and sham for quartiles 1 to 4 at 24 months. CONCLUSIONS Deep learning-based OCT analysis objectively identifies and quantifies PR and RPE degeneration in GA. Reductions in further EZ loss on OCT are even higher than the effect on RPE loss in phase 3 trials of pegcetacoplan treatment. The EZ-RPE difference has a strong impact on disease progression and therapeutic response. Identification of patients with higher EZ-RPE loss difference may become an important criterion for the management of GA secondary to AMD. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
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A head-to-head comparison of the effects of aerobic versus resistance training on physical capacity and physical function in people with multiple sclerosis: Results from the MSBOOST trial.
Taul-Madsen, L, Hvid, LG, Riis, H, Broløs, MK, Lundbye-Jensen, J, Dalgas, U
Multiple sclerosis (Houndmills, Basingstoke, England). 2025;(2):174-183
Abstract
BACKGROUND Exercise is a safe and effective way to improve physical function in people with multiple sclerosis (PWMS). OBJECTIVES This study aimed to perform a head-to-head study of the effects of aerobic and resistance training on physical capacity and physical function. METHODS A multicentre randomized controlled trial with 150 participants was conducted. Participants were randomized into 12 weeks of either aerobic training (AT; n = 62), resistance training (RT; n = 57), or usual care (UC; n = 31). The primary outcome was physical function (measured as a composite score of the 6-minute walk test and five-time sit-to-stand). Secondary outcomes were aerobic capacity (VO2peak), maximal muscle strength (MVC), and self-reported walking ability. RESULTS Participants had a mean age of 45.5 (8.8), an expanded disability status scale (EDSS) of 2.8 (1.5), and 75% were female. Physical function did not increase in AT versus UC 0.08 [-0.16; 0.33] (mean (95% CI)) nor in RT versus UC 0.09 [-0.15; 0.34].VO2peak increased in AT versus UC by 4.1 [2.0; 6.3] mL O2/min/kg and in AT versus RT by 2.7 [1.1; 4.3], but not in RT versus UC 1.4 [-0.6; 3.5]. MVC increased in RT versus UC by 0.25 [0.01; 0.48] Nm/kg, but not in RT versus AT 0.17 [-0.02; 0.36] or AT versus UC 0.08 [-0.16; 0.31]). CONCLUSION AT and RT elicited improvements in physical capacity in PWMS. However, these improvements only moderately translated into improvements in physical function.Clinicaltrials.gov (NCT04913012)https://clinicaltrials.gov/study/NCT04913012.
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A High-Resolution Microendoscope Improves Esophageal Cancer Screening and Surveillance: Implications for Underserved Global Settings Based on an International Randomized Controlled Trial.
Tan, MC, Li, Z, Patel, KK, Zhang, F, Yu, X, Wang, X, Rosen, DG, Dawsey, SM, Xue, L, Hur, C, et al
Gastroenterology. 2025;(3):496-507.e3
Abstract
BACKGROUND & AIMS Lugol's chromoendoscopy (LCE)-based detection of esophageal squamous cell neoplasia (ESCN) is limited by low specificity. High-resolution microendoscopy (HRME) was shown to improve specificity and reduce unnecessary biopsies when used by academic endoscopists. In this international randomized controlled trial, we determined the clinical impact, efficiency, and performance of HRME in true global health contexts with a range of providers. METHODS Individuals undergoing screening or surveillance for ESCN by expert and novice endoscopists were enrolled in China and the United States from diverse clinical settings. Participants were randomized to LCE (standard of care) or LCE + HRME (experimental). The primary outcomes were the efficiency and clinical impact of LCE vs LCE + HRME using gold-standard consensus pathology. RESULTS Among 916 consented participants, 859 (93.8%) were recruited in China and 36 (3.9%) in the United States; 21 (2.3%) were excluded due to incomplete procedure or data. In the screening arm, 217 participants were randomized to LCE and 204 to LCE + HRME; in the surveillance arm, 236 were randomized to LCE and 238 to LCE + HRME. HRME increased efficiency in screening: diagnostic yield (neoplastic/total biopsies) improved from 20.0% (95% confidence interval [CI], 12.7-29.2) to 51.7% (95% CI, 32.5-70.6) with 65.2% (95% CI, 54.6-74.9) of biopsies potentially saved and 59.7% (95% CI, 47.5-71.1) of participants potentially spared any biopsy. Six participants (0.7%) had neoplasia missed by the endoscopist on HRME (false negatives); of these, 3 were moderate or high-grade dysplasia missed by novices. CONCLUSIONS A low-cost microendoscope improves the efficiency and clinical impact of ESCN screening and surveillance when combined with LCE. HRME may spare unnecessary biopsies, leading to cost savings in underserved global settings where the disease is prevalent. (ClinicalTrials.gov, Number NCT02029937).
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In People With Subacute Mild Traumatic Brain Injury, Earlier Physical Therapy Improved Symptoms at a Faster Rate Than Later Physical Therapy: Randomized Controlled Trial.
Campbell, KR, Antonellis, P, Peterka, RJ, Wilhelm, JL, Scanlan, KT, Pettigrew, NC, Chen, S, Parrington, L, Fino, PC, Chesnutt, JC, et al
Physical therapy. 2025;(2)
Abstract
IMPORTANCE There is unclear evidence on when to initiate physical therapy after mild traumatic brain injury (mTBI) in a non-athlete, adult population. OBJECTIVE The objective of this study was to investigate physical therapy timing after mTBI through changes in patient-reported and clinically-assessed tools and objective and mechanism measurements of sensorimotor balance control. DESIGN This study was an investigator-blinded randomized control trial (NCT03479541). SETTING The study took place at an academic research center. PARTICIPANTS Two hundred and three participants were randomized to earlier physical therapy (n = 82) or to later physical therapy (n = 121). INTERVENTION After enrollment, the earlier physical therapy group started rehabilitation within 1 week and the later group started rehabilitation after a 6-week wait period. All participants received similar rehabilitation; 6-week program administered and progressed by licensed physical therapists. MAIN OUTCOMES AND MEASURES The primary outcome was the Dizziness Handicap Inventory (DHI). Secondary outcomes included common patient-reported/clinical assessments of mTBI and objective/mechanism measurements of balance, including novel measures of central sensorimotor integration. Differences between and within the groups on outcomes were examined with linear mixed-effect models, t tests, and effect sizes. RESULTS While both groups significantly improved and reached similar levels on patient-reported outcomes (DHI and secondary outcomes), the earlier physical therapy group had significantly larger and faster rates of improvement compared to later physical therapy. There were differential effects of physical therapy timing on the objective/mechanism-measured outcomes. Specifically, there were significant improvements in sensorimotor time delay for the earlier physical therapy group and no change in the later group. Further, the later group worsened in the motor activation components for balance control while there was no change in the early group. CONCLUSION AND RELEVANCE Earlier physical therapy after mTBI can improve symptoms at a faster rate relative to later physical therapy. Earlier physical therapy also showed improvements in sensorimotor aspects of balance control, not seen in the later group. There may be an important window to address central sensorimotor deficits after mTBI.
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The impact of a fairytale-like story on the food choices of preschool children.
Zahedi, A, Katembu, S, Sind, SM, Sommer, U, Kimamo, C, Sommer, W
Appetite. 2025;:107839
Abstract
The ongoing obesity epidemic is an indicator that traditional efforts towards diet change are insufficient, and interventions focusing mainly on restrictions of unhealthy food are of limited success. Therefore, approaches targeting food preferences should be integral in counteracting the current epidemic. However, food preferences are affected by a multitude of factors and are usually resistant to changes later in life. Hence, we tested whether the food choices of preschool children can be changed by a child-appropriate, interactive, fairytale-like narrative. We used two interactive stories: the first (experimental) story was about how two protagonists of similar age as the participants saved their hometown from being drained of color with the help of magic fruits or vegetables, while the second (control) story consisted of a similar plot that did not mention food. In Experiment 1, we used a crossover design with a one-week baseline measurement. After the experimental stories, healthy food choices (i.e., pieces of fruit vs. cookies, sweets, or cake) increased significantly relative to the one-week baseline, whereas no change was observed after the control story. In preregistered Experiment 2, we replicated these results with vegetables as healthy options using a random control design and investigated the longevity of the effects. The food-story effect on vegetable choices was similar to fruits (Exp. 1) and lasted for two weeks. These findings demonstrate that appropriate narratives about food can have a strong and lasting effect on the healthy food choices of preschool children and might promote healthy food consumption if incorporated into nutrition education.
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Modulation of hormonal, metabolic, inflammatory and oxidative stress biomarkers in women with polycystic ovary syndrome following combined (resistant and endurance) training: a randomized controlled trail.
Nasiri, M, Monazzami, A, Alavimilani, S, Asemi, Z
BMC endocrine disorders. 2025;(1):1
Abstract
PURPOSE Polycystic ovary syndrome (PCOS) is a frequent disorder among women. Exercise training has been known as an effective treatment for this disorder; however, there is small amount of evidence examining the optimal exercise programs. We evaluated the function of combined (COM) training on metabolic, hormonal parameters, and biomarkers of oxidative stress and inflammation in PCOS patients. METHODS This randomized controlled clinical trial was conducted on 30 women with PCOS divided (age: 23.8 ± 5.3 years, height:162.8 ± 4.9 cm, weight: 82.4 ± 9.7 kg, body mass index: 30.3 ± 3.9 kg/m2) into two groups to receive COM training intervention (n = 15) or control group (n = 15) for eight weeks. At the baseline and end-of-intervention, metabolic profiles including fasting plasma glucose, insulin, homeostatic model assessment for insulin resistance (HOMA-IR), quantitative insulin sensitivity check index (QUICKI), lipid profiles, testosterone, free androgen index (FAI), sex hormone binding globulin, anti-Müllerian hormone, malondialdehyde, total antioxidant capacity, and high Sensitive-C reactive protein were evaluated. RESULTS After eight-week intervention in training group, insulin (P < 0.001), HOMA-IR (P < 0.001), total cholesterol (P < 0.001), LDL-cholesterol (P < 0.001), total testosterone (P < 0.001), AMH ( P = 0.02),MDA (P = 0.04) and FAI (P < 0.001) were significantly decreased, while QUICKI (P = 0.002) was remarkably increased compared with the control group. Moreover, findings showed that there are no significant differences in other variables in the training group compared to the control group. CONCLUSIONS We concluded that combined training is an effective training protocol (50%-70% 1RM for strength training and 60%-70 THR for endurance training) for treatment of PCOS, although further studies are needed to reach comprehensive data regarding the design of exercise protocols with different intensity and volume for PCOS patients. TRIAL REGISTRATION Registered retrospectively in the Iranian Registry of Clinical Trials (IRCT20130812014333N143) on March 22, 2020. Access at https://en.irct.ir/trial/46295 .
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Testing the carbohydrate-insulin model: Short-term metabolic responses to consumption of meals with varying glycemic index in healthy adults.
Liu, Y, Mei, H, Xue, L, Cheng, C, Wu, Y, Zou, C, Yu, Y, Gao, L, Zhang, H, Gao, X, et al
Cell metabolism. 2025;(3):606-615.e3
Abstract
The carbohydrate-insulin model predicts that meals with varying glycemic indices will elicit distinct metabolic and hunger responses, including greater intake at subsequent meals following high-glycemic-index meals. To test this, a randomized trial (NCT05804942) was conducted in healthy adults using intervention meals with low, medium, and high glycemic indices and a constant macronutrient composition. After intake of the intervention meals, glucose and insulin followed the predicted pattern, but subjective hunger did not. At the group level, low glycemic index meals led to lower energy intake changes. At the individual level, energy intake changes were unrelated to body fatness or levels of glucose, β-hydroxybutyrate, free fatty acids, L-lactate, leptin, adrenaline, glucagon-like peptide-1, glucagon, and insulin-glucagon ratio. A weak negative association was observed between energy intake changes and insulin or insulin-glucagon ratio at 300 min, opposite to the model's prediction. These data provide little support for the carbohydrate-insulin model.
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Laparoscopic Pylorus-preserving Gastrectomy Versus Distal Gastrectomy for Early Gastric Cancer: A Multicenter Randomized Controlled Trial (KLASS-04).
Lee, HJ, Kim, YW, Park, DJ, Han, SU, Ryu, KW, Kim, HH, Hyung, WJ, Park, JH, Suh, YS, Kwon, OK, et al
Annals of surgery. 2025;(4):573-581
Abstract
OBJECTIVE To evaluate the long-term outcomes of laparoscopic pylorus-preserving gastrectomy (LPPG) with laparoscopic distal gastrectomy (LDG) for early gastric cancer. BACKGROUND Pylorus-preserving gastrectomy is considered a function-preserving surgery for early gastric cancer. However, there has been no multicenter randomized controlled trial comparing pylorus-preserving gastrectomy with distal gastrectomy until now. METHODS A multicenter randomized controlled trial (KLASS-04) with 256 patients with cT1N0M0 gastric cancer located in the mid portion of the stomach was conducted. The primary endpoint was the incidence of dumping syndrome at postoperative 1 year. Secondary endpoints included survival and recurrence, gallstone formation, nutritional parameters, gastroscopic findings, and quality of life for 3 years. RESULTS In the intention-to-treat analyses, there was no difference in the incidence of dumping syndrome at 1 year postoperatively (13.2% in LPPG vs 15.8% in LDG, P = 0.622). Gallstone formation after surgery was significantly lower in LPPG than in LDG (2.33% vs 8.66%, P = 0.026). Hemoglobin (+0.01 vs -0.76 gm/dL, P < 0.001) and serum protein (-0.15 vs -0.35 gm/dL, P = 0.002) were significantly preserved after LPPG. However, reflux esophagitis (17.8% vs 6.3%, P = 0.005) and grade IV delayed gastric emptying (16.3% vs 3.9%, P = 0.001) were more common in LPPG. Changes in body weight and postoperative quality of life were not significantly different between groups. Three-year overall survival and disease-free survival were not different (1 case of recurrence in each group, P = 0.98). CONCLUSIONS LPPG can be used as an alternative surgical option for cT1N0M0 gastric cancer in the mid portion of the stomach.
