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Progressive exercise training improves cardiovascular psychophysiological outcomes in young adult women with a history of adverse childhood experiences.
Rogers, EM, Banks, NF, Tomko, PM, Sciarrillo, CM, Emerson, SR, Thomas, EBK, Taylor, A, Teague, TK, Jenkins, NDM
Journal of applied physiology (Bethesda, Md. : 1985). 2023;(3):742-752
Abstract
Adverse childhood experiences (ACEs) are early-life psychosocial stressors that are associated with poorer mental health and increased cardiovascular disease (CVD) risk in a dose-dependent manner. We examined the feasibility of an 8-wk combined aerobic and resistance exercise training program to improve systolic (SBP) and diastolic blood pressure (DBP), serum endothelin-1 (ET-1), resilience, hope agency, and hope pathways in young women with ACEs. Forty-two healthy women (21 ± 3 yr) with ≥4 (ACE+; n = 28) or 0 ACEs (ACE-; n = 14) participated in this study. Women with ACEs were randomly assigned to an exercise (ACE+EXT; n = 14) or nonexercise control (ACE+CON; n = 14) group, whereas all ACE- participants were assigned to a nonexercise control (n = 14) group. Hope agency and DBP did not change in any group (P ≥ 0.43), but hope pathways improved only in ACE+EXT (means ± SE change; +1.6 ± 0.74 au, P = 0.032, Hedges' g = 0.53). ET-1 decreased in ACE+EXT only (-0.31 ± 0.15 pg/mL, P = 0.043, g = 0.46). Although the interactions for resilience and SBP did not reach significance (P = 0.05-0.06), forced post hoc analyses indicated that resilience improved (+4.9 ± 1.9 au, P = 0.012, g = 0.64) and SBP tended to improve (-4.0 ± 2.0 mmHg, P = 0.053, g = 0.51) in ACE+EXT only. There were significant associations between changes in hope pathways and SBP (ρ = -0.43, P = 0.023) and ET-1 (ρ = -0.53, P = 0.005), and between changes in SBP and ET-1 (ρ = 0.49; P = 0.012) in the ACE+ group. In summary, structured exercise training reduces serum ET-1 levels, improves positive psychological coping, and may improve SBP in young women with ACEs. The relationships among the changes in hope pathways, SBP, and ET-1 suggest a cardiovascular psychophysiological relationship in young women with ACEs.NEW & NOTEWORTHY This randomized controlled pilot trial shows, for the first time, that 8 wk of structured, progressive exercise training lowers serum endothelin-1 (ET-1) and improves positive psychological coping in young women with significant early-life psychosocial stress. Furthermore, the observed associations among changes in psychological attributes, ET-1, and systolic blood pressure signify a potential interplay between positive psychology and cardiovascular disease risk among women with adverse childhood experiences.
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A Randomized, Controlled Trial of Efficacy and Safety of Cannabidiol in Idiopathic and Diabetic Gastroparesis.
Zheng, T, BouSaba, J, Taylor, A, Dilmaghani, S, Busciglio, I, Carlson, P, Torres, M, Ryks, M, Burton, D, Harmsen, WS, et al
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2023;(13):3405-3414.e4
Abstract
BACKGROUND & AIMS Cannabis (delta-9-tetrahydrocannabinol), a nonselective cannabinoid-receptor agonist, relieves nausea and pain. Cannabidiol (CBD), a cannabinoid receptor 2 inverse agonist with central effects, also reduces gut sensation and inflammation. We compared the effects of 4 weeks of treatment with pharmaceutical CBD vs placebo in patients with idiopathic or diabetic (diabetes mellitus) gastroparesis. METHODS We performed a randomized, double-blinded, placebo-controlled study of CBD twice daily (Epidiolex escalated to 20 mg/kg/d; Jazz Pharmaceuticals, Dublin, Ireland) in patients with nonsurgical gastroparesis with delayed gastric emptying of solids (GES). Symptoms were assessed by the Gastroparesis Cardinal Symptom Index Daily Diary. After 4 weeks of treatment, we measured GES, gastric volumes, and Ensure (Abbott Laboratories, Abbott Park, IL) satiation test (1 kcal/mL, 30 mL/min) to assess volume to comfortable fullness and maximum tolerance. Patients underwent specific FAAH and CNR1 genotyping. Statistical analysis compared 2 treatments using analysis of variance including baseline measurements and body mass index as covariates. RESULTS Among 44 patients (32 idiopathic, 6 diabetes mellitus type 1, and 6 diabetes mellitus type 2), 5 patients did not tolerate full-dose escalation; 3 withdrew before completing 4 weeks of treatment (2 placebo, 1 CBD); 95% completed 4 weeks of treatment and diaries. Compared with placebo, CBD reduced the total Gastroparesis Cardinal Symptom Index score (P = .008), inability to finish a normal-sized meal (P = .029), number of vomiting episodes/24 hours (P = .006), and overall symptom severity (P = .034). Patients treated with CBD had a higher volume to comfortable fullness and maximum tolerance and slower GES. FAAH rs34420 genotype significantly impacted nutrient drink ingestion. The most common adverse events reported were diarrhea (14 patients), fatigue (8 patients), headache (8 patients), and nausea (7 patients). CONCLUSIONS CBD provides symptom relief in patients with gastroparesis and improves the tolerance of liquid nutrient intake, despite slowing of GES. CLINICALTRIALS gov NCT #03941288.
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Randomised single centre double-blind placebo controlled phase II trial of Tocovid SupraBio in combination with pentoxifylline in patients suffering long-term gastrointestinal adverse effects of radiotherapy for pelvic cancer: The PPALM study.
Andreyev, HJN, Matthews, J, Adams, C, Gothard, L, Lucy, C, Tovey, H, Boyle, S, Anbalagan, S, Musallam, A, Yarnold, J, et al
Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology. 2022;:130-137
Abstract
BACKGROUND Preclinical data suggest that combined gamma-tocotrienol with pentoxifylline ameliorates radiotherapy-induced gastrointestinal damage. AIM: To test whether gastrointestinal symptoms arising after radiotherapy, and persisting after maximal medical therapy, can be improved using Tocovid SupraBio 200 mg and pentoxifylline 400 mg orally twice daily for one year. Patients stratified by severity of symptoms, and randomised to active treatment or matched placebo were assessed after 12 months. The primary end point was improvement in gastrointestinal symptoms measured using the Inflammatory Bowel Disease Questionnaire, bowel subset score. Changes in bio-markers of fibrosis were assessed. RESULTS 62 patients, median age 66, 34(55%) treated for prostate, 21(34%) gynaecological, 6(10%) anal and one(1%) rectal cancer were recruited; 40(65%) randomised to treatment, 22(35%) to placebo, 39 months (median) after radiotherapy completion. Gamma tocotrienol was not detected in serum in 41% of treated patients, despite good compliance with study medication. Treatment was completed in 28(70%) and 17(77%) patients in the treatment and placebo groups respectively. No improvement in symptom scores nor in quality of life was identified. Thirteen serious adverse events occurred. A transient ischaemic attack, was possibly related to pentoxifylline, others were assessed as unlikely to be related to treatment. Levels of EGF, PDGF and FGF were significantly reduced and consistent trends in reduced inflammation were seen during treatment but were not sustained once treatment ended. SUMMARY This single centre study closed prematurely and therefore data interpretation is of necessity limited. No clinical benefit was demonstrated. However, biochemical data suggest that this intervention does have anti-inflammatory and anti-fibrotic effects.
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A Provider-Focused Intervention to Promote Optimal Care of Pediatric Patients With Suspected Elbow Fracture.
Diaz, MCG, Werk, LN, Crutchfield, JH, Handy, LK, Franciosi, JP, Dent, J, Villanueva, R, Antico, E, Taylor, A, Wysocki, T
Pediatric emergency care. 2021;(12):e1663-e1669
Abstract
OBJECTIVE Emergency department (ED) and urgent care (UC) physicians' accurate assessment of the neurovascular and musculoskeletal (NV/MSK) examination in pediatric patients with suspected elbow fracture is crucial to the early recognition of neurovascular compromise. Our objective was to determine the impact of computer-based simulation (CBS) and computerized clinical decision support systems (CCDSS) on ED and UC physicians' assessment of the NV/MSK examination of pediatric patients with elbow fracture as noted in their documentation. METHODS All ED UC physician participants received CBS training about management of pediatric patients with suspected elbow fracture. Participants were then randomized to receive CCDSS (intervention arm) when an eligible patient was seen or no further intervention (comparison arm.) Participants received feedback on the proportion of patients with discharge diagnosis of elbow fracturewith proper examination elements documented. RESULTS Twenty-eight ED and UC physicians were enrolled - 14 in each arm. Over the span of 16 weeks, 50 patients with a discharge diagnosis of elbow fracture were seen - 25 in each arm. Twenty-two of 25 (88%) patients seen by intervention arm participants had a complete NV/MSK examination documented. Six of 25 (24%) patients seen by comparison arm participants had a complete NV/MSK examination documented. Elements most commonly missed in the comparison arm included documentation of ulnar pulse as well as radial, median, and ulnar nerve motor functions. CONCLUSIONS Compared with single CBS training alone, repeated exposure to CCDSS after CBS training resulted in improved documentation of the NV/MSK status of pediatric patients with elbow fracture.
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Feasibility and Efficacy of the "FUNPALs Playgroup" Intervention to Improve Toddler Dietary and Activity Behaviors: A Pilot Randomized Controlled Trial.
Cepni, AB, Taylor, A, Crumbley, C, Thompson, D, Moran, NE, Olvera, N, O'Connor, DP, Arlinghaus, KR, Johnston, CA, Ledoux, TA
International journal of environmental research and public health. 2021;(15)
Abstract
This study evaluated the feasibility and effects of the Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup on toddler (12-36-month-old) diet and activity behaviors. Parent-toddler dyads were recruited from disadvantaged communities and randomly assigned to receive 10-weekly sessions of the FUNPALs Playgroup (n = 24) or dose-matched health education control group (n = 26). FUNPALs Playgroups involved physical and snack activities, delivery of health information, and positive parenting coaching. The control group involved group health education for parents only. Process outcomes (e.g., retention rate, fidelity) and focus groups determined feasibility and perceived effects. To evaluate preliminary effects, validated measures of toddler diet (food frequency questionnaire and a carotenoid biomarker), physical activity (PA; accelerometers), general and feeding parenting (self-report surveys), and home environment (phone interview) were collected pre and post. The sample comprised parents (84% female) who self-identified as Hispanic/Latino (38%) and/or African American (32%). Retention was high (78%). Parents from both groups enjoyed the program and perceived improvements in their children's health behaviors. Objective measures demonstrated improvement with large effects (η2 = 0.29) in toddler diet (p < 0.001) but not PA (p = 0.099). In conclusion, the FUNPALs Playgroup is feasible and may improve toddler eating behaviors.
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Exploring qualities of ethnically diverse parents related to the healthy home environment of toddlers.
Cepni, AB, Taylor, A, Thompson, D, Moran, NE, Olvera, N, O'Connor, DP, Johnston, CA, Ledoux, TA
Appetite. 2021;:105608
Abstract
Parents serve as role models and household policy makers for their children's home social environment. Also, parents may influence the home physical environment through the provision of resources to support their children's dietary, activity, and sleep behaviors. Understanding the parental characteristics related to children's home environment may allow for tailoring obesity interventions to families' needs. This study aimed to explore parental qualities (general parenting styles, parent feeding practices, and parental BMI) related to healthy home food, physical activity, media and sleep environment of toddlers. A total of 50 multi-ethnic parents with toddler age children who were enrolled in a randomized pilot study of a wellness program completed the Structure and Control in Parent Feeding (SCPF) questionnaire and Comprehensive General Parenting Questionnaire (CGPQ). Parental BMI was calculated using self-reported weight and height data. The Healthy Home Survey, the Home Food Inventory, the Sleep Environment Questionnaire, and items developed for this study were standardized and summed to create home food, physical activity, screen media, and sleep environment scores; high scores reflected healthier environments. To examine the relationships between parental qualities and the home environment, Pearson's correlation test was performed. Parental BMI and overall healthy home environment were inversely associated (r = -0.306; p = 0.032). Structure in general parenting and parental feeding practice were positively correlated with the overall healthy home environment (r = 0.336; p = 0.026) and healthy home food environment (r = 0.415; p = 0.003), respectively. The coercive control general parenting was inversely related to overall healthy home environment score (r = -0.333; p = 0.022). Based on the findings from this study, parents who provide clear communication, set consistent rules, avoid pressure to control their child's behavior, and have lower BMI tend to live in a home environment that support children's health behaviors.
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Randomized controlled trial of dietary fiber for the prevention of radiation-induced gastrointestinal toxicity during pelvic radiotherapy.
Wedlake, L, Shaw, C, McNair, H, Lalji, A, Mohammed, K, Klopper, T, Allan, L, Tait, D, Hawkins, M, Somaiah, N, et al
The American journal of clinical nutrition. 2017;(3):849-857
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Abstract
Background: Therapeutic radiotherapy is an important treatment of pelvic cancers. Historically, low-fiber diets have been recommended despite a lack of evidence and potentially beneficial mechanisms of fiber.Objective: This randomized controlled trial compared low-, habitual-, and high-fiber diets for the prevention of gastrointestinal toxicity in patients undergoing pelvic radiotherapy.Design: Patients were randomly assigned to low-fiber [≤10 g nonstarch polysaccharide (NSP)/d], habitual-fiber (control), or high-fiber (≥18 g NSP/d) diets and received individualized counseling at the start of radiotherapy to achieve these targets. The primary endpoint was the difference between groups in the change in the Inflammatory Bowel Disease Questionnaire-Bowel Subset (IBDQ-B) score between the starting and nadir (worst) score during treatment. Other measures included macronutrient intake, stool diaries, and fecal short-chain fatty acid concentrations.Results: Patients were randomly assigned to low-fiber (n = 55), habitual-fiber (n = 55), or high-fiber (n = 56) dietary advice. Fiber intakes were significantly different between groups (P < 0.001). The difference between groups in the change in IBDQ-B scores between the start and nadir was not significant (P = 0.093). However, the change in score between the start and end of radiotherapy was smaller in the high-fiber group (mean ± SD: -3.7 ± 12.8) than in the habitual-fiber group (-10.8 ± 13.5; P = 0.011). At 1-y postradiotherapy (n = 126) the difference in IBDQ-B scores between the high-fiber (+0.1 ± 14.5) and the habitual-fiber (-8.4 ± 13.3) groups was significant (P = 0.004). No significant differences were observed in stool frequency or form or in short-chain fatty acid concentrations. Significant reductions in energy, protein, and fat intake occurred in the low- and habitual-fiber groups only.Conclusions: Dietary advice to follow a high-fiber diet during pelvic radiotherapy resulted in reduced gastrointestinal toxicity both acutely and at 1 y compared with habitual-fiber intake. Restrictive, non-evidence-based advice to reduce fiber intake in this setting should be abandoned. This trial was registered at clinicaltrials.gov as NCT 01170299.
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Oxandrolone Augmentation of Resistance Training in Older Women: A Randomized Trial.
Mavros, Y, O'Neill, E, Connerty, M, Bean, JF, Broe, K, Kiel, DP, Maclean, D, Taylor, A, Fielding, RA, Singh, MA
Medicine and science in sports and exercise. 2015;(11):2257-67
Abstract
INTRODUCTION Sarcopenia is disproportionately present in older women with disability, and optimum treatment is not clear. We conducted a double-blind, randomized, placebo-controlled trial to determine whether oxandrolone administration in elderly women improves body composition or physical function beyond that which occurs in response to progressive resistance training (PRT). METHODS Twenty-nine sedentary women (age 74.9 ± 6.8 yr; 5.9 ± 2.8 medications per day) were randomized to receive high-intensity PRT (three times a week for 12 wk) combined with either oxandrolone (10 mg·d(-1)) or an identical placebo. Peak strength was assessed for leg press, chest press, triceps, knee extension, and knee flexion. Power was assessed for leg press and chest press. Physical function measures included static and dynamic balance, chair rise, stair climb, gait speed, and 6-min walk test. Body composition was assessed using dual energy x-ray absorptiometry. RESULTS Oxandrolone treatment augmented increases in lean tissue for the whole body (2.6 kg; 95% confidence interval (CI), 1.0-4.2 kg; P = 0.003), arms (0.3 kg; 95% CI, 0.1-0.5 kg; P = 0.001), legs (0.8 kg; 95% CI, 0.1-1.4 kg; P = 0.018), and trunk (1.4 kg; 95% CI, 0.4-2.3 kg; P = 0.004). Oxandrolone also augmented loss of fat tissue of the whole body (-1 kg; 95% CI, -1.6 to -0.4; P = 0.002), arms (-0.2 kg; 95% CI, -0.5 to -0.02 kg; P = 0.032), legs (-0.4 kg; 95% CI, -0.6 to -0.1; P = 0.009), and tended to reduce trunk fat (-0.4 kg; 95% CI, -0.9 to 0.04; P = 0.07). Improvements in muscle strength and power, chair stand, and dynamic balance were all significant over time (P < 0.05) but not different between groups (P > 0.05). CONCLUSIONS Oxandrolone improves body composition adaptations to PRT in older women over 12 wk without augmenting muscle function or functional performance beyond that of PRT alone.
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The Effect of Lipid Modification on Peripheral Artery Disease after Endovascular Intervention Trial (ELIMIT).
Brunner, G, Yang, EY, Kumar, A, Sun, W, Virani, SS, Negi, SI, Murray, T, Lin, PH, Hoogeveen, RC, Chen, C, et al
Atherosclerosis. 2013;(2):371-7
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Abstract
METHODS A total of 102 patients were randomized to either mono-therapy with simvastatin (40 mg daily) or triple-therapy with simvastatin (40 mg daily), extended-release niacin (1500 mg daily), and ezetimibe (10 mg daily). MRI was performed at baseline and 6, 12, and 24 months. SFA wall, lumen, and total vessel volumes were quantified. MRI-derived SFA parameters and lipids were analyzed with multilevel models and nonparametric tests, respectively. RESULTS Baseline characteristics did not differ between mono and triple-therapy groups, except for ethnicity (p = 0.02). SFA wall, lumen, and total vessel volumes increased non-significantly for both groups between baseline and 24-months. Non-high-density lipoprotein cholesterol was significantly reduced at 12 months with triple-therapy compared with mono-therapy (p = 0.01). CONCLUSION No significant differences were observed between mono-therapy using simvastatin and triple-therapy with simvastatin, extended-release niacin, and ezetimibe for 24-month changes in SFA wall, lumen, and total vessel volumes. CLINICAL TRIAL REGISTRATION INFORMATION NCT00687076; Link: http://clinicaltrials.gov/ct2/show/NCT00687076.
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A pilot randomized controlled trial of a brief early intervention for reducing posttraumatic stress disorder, anxiety and depressive symptoms in newly diagnosed head and neck cancer patients.
Kangas, M, Milross, C, Taylor, A, Bryant, RA
Psycho-oncology. 2013;(7):1665-73
Abstract
OBJECTIVE Head and neck cancer (HNC) patients have a high incidence of cancer-related posttraumatic stress disorder (PTSD) and other anxiety and depressive disorders. We report the results from the first pilot randomized controlled trial in which the efficacy of an early cognitive-behavioral therapy (CBT) program was compared with a non-directive supportive counseling (SC) intervention in reducing PTSD, general anxiety and depressive symptoms, and improving perceived quality of life in newly diagnosed, distressed HNC patients undergoing radiotherapy. PATIENTS AND METHODS Thirty-five HNC patients (mean age=54.8 years; 80% males) with elevated levels of PTSD, depression or anxiety were randomized to seven individual sessions of a multi-modal CBT or non-directive SC, concurrent with patients' radiotherapy. The SC intervention provided non-directive counseling support. PTSD, anxiety and depressive symptoms (primary outcomes), and cancer-related appraisals and quality of life (secondary outcomes) were assessed pre-intervention (baseline), 1 month, 6 months and 12 months post-intervention by diagnostic clinical interviews and validated self-report questionnaires. RESULTS The CBT and SC interventions were found to be equal in their effects in reducing PTSD and anxiety symptoms both in the short and longer term. However, up to 67% of patients in the CBT program no longer met clinical or sub-clinical PTSD, anxiety and/or depression by 12 months post-treatment compared with 25% of patients who received SC. CONCLUSION Findings indicate that the early provision of psychotherapy has utility in reducing PTSD, anxiety and depressive symptoms, and preventing chronic psychopathology in distressed HNC patients.