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This chapter summarizes the epidemiological study design of natural immune epidemiology studies based on recent COVID-19-related research. The epidemiological studies on antiviral innate immunity have mainly included randomized controlled trials (RCTs) and observational studies. Importantly, this chapter will discuss how to use these methodologies to answer an epidemiological question of natural immunity in the viral infection process based on previous studies. An observational case- or cohort-based study of antiviral innate immunity may support this theoretical hypothesis but is not appropriate for clinical practice or treatment. RCTs are the gold standard for epidemiological studies and occupy a greater role in the hierarchy of evidence.

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INTRODUCTION: The head and neck comprise vital organs and are apparent human body parts. Tumours here impair physical and sensory functions as well as appearance and social interactions, leading to body image distress (BID) and threatening mental health and quality of life. Acceptance and commitment therapy has shown effectiveness in improving BID in groups such as breast cancer patients. This study aims to apply this therapy to intervene in head and neck cancer (HNC) patients, aiming to improve BID and promote better psychological well-being. METHODS AND ANALYSIS: This study is a prospective, parallel-group, randomised controlled trial. A total of 64 HNC patients will be allocated to either an intervention group or a control group. The intervention group will engage in a 3 week, six-session group-based acceptance and commitment therapy programme, while the control group will receive standard treatment. The primary outcome is cancer-related BID, and secondary outcomes are HNC-related BID, psychological flexibility, coping style and psychological distress. These indicators will be measured at baseline, postintervention and 1 month following the intervention's completion. ETHICS AND DISSEMINATION: The trial has received approval from the Institutional Review Board of Shanghai Proton and Heavy Ion Hospital (2308-67-02). The study results will be shared through peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER: ChiCTR2300077863.

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The aim of the present study was to compare the effectiveness of AI-assisted training and conventional human training in clinical practice. This was a multicenter, randomized, controlled clinical trial conducted in five national-level residency training hospitals. Residents from five hospitals participated, divided into three groups: conventional training (Group A), conventional plus specialty training (Group B), and conventional plus AI-assisted training (Group C). The content of the training was ultrasound diagnosis of thyroid nodules. The training lasted for 18 months, and the three groups of participants were phase-tested every 3 months to compare the effect of the training. The diagnostic accuracy of all three groups gradually increased with increasing training time. Among the three groups, groups B and C had higher accuracy than group A (P < .001), and there was no significant difference between groups B and C (P = .64). Over the training period, diagnostic confidence increased in all groups. Negative activating emotions decreased significantly over time in all groups (95% CI, - 0.81 to - 0.37; P < .001), while positive activating emotions increased significantly (95% CI, 0.18 to 0.53; P < .001). Current research shows that all three approaches are viable for training radiology residents. Furthermore, the AI-assisted approach had no negative emotional impact on the trainees, suggesting that integrating AI into radiology training programs could provide a reliable and effective means of achieving the educational goals of medical education.

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BACKGROUND: Male factory workers in China are vulnerable to HIV transmission. Commercial and nonmarital noncommercial contacts are the driving forces of heterosexual HIV transmission among male factory workers in China. There is a lack of effective HIV interventions for male factory workers in China. OBJECTIVE: The primary objective of this randomized controlled trial was to compare the efficacy of an enhanced versus the standard version of a WeChat mini program in reducing sexual intercourse with nonregular female sex partners and female sex workers among male factory workers in Shenzhen, China. METHODS: A nonblinded 2-arm parallel randomized controlled trial was conducted between December 2021 and April 2023. Participants were adult male factory workers in Shenzhen who had access to a smartphone and WeChat. Those who had oral or anal sex with a man or self-reported as HIV positive were excluded. A total of 247 participants were randomly assigned to the intervention group (n=125, 50.6%) or the control group (n=122, 49.4%); 221 (89.5%) and 220 (89.1%) completed follow-up surveys at T1 (6 months after completion of the interventions) and T2 (6 months after T1). Participants in the control group had access to the standard WeChat mini program that provided basic HIV-related knowledge and information about local free HIV testing services. Participants in the intervention group had access to the enhanced WeChat mini program. The enhanced mini program covered all the information in the standard mini program. In addition, the enhanced mini program assessed users' behaviors and invited users to watch different web-based videos on reducing nonmarital sexual contacts and promoting HIV testing based on their behavioral characteristics at months 0 and 1. The videos were developed based on in-depth interviews with male factory workers. Intention-to-treat analysis was used for outcome analyses. Multiple imputation was used to replace missing outcome values at T1 and T2. RESULTS: At T1, fewer participants in the intervention group reported sexual intercourse with a nonregular female sex partner in the past 6 months compared with the control group (1/125, 0.8% vs 8/122, 6.6%; relative risk=0.12, 95% CI 0.02-0.96; P=.02). However, there were no between-group differences in sexual intercourse with a nonregular female sex partner at T2 (10/125, 8% vs 14/122, 11.5%; P=.36) or sexual intercourse with a female sex worker at T1 (2/125, 1.6% vs 2/122, 1.6%; P=.98) or T2 (8/125, 6.4% vs 8/122, 6.6%; P=.96). CONCLUSIONS: The enhanced WeChat mini program was more effective than the standard WeChat mini program in reducing sexual intercourse with nonregular female sex partners among male factory workers in the short term but not in the longer term. Improvements should be made to the WeChat mini program before implementation. TRIAL REGISTRATION: ClinicalTrials.gov NCT05811611; https://clinicaltrials.gov/study/NCT05811611.

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OBJECTIVE: Test the efficacy of a brief 2-hr parenting intervention in increasing protective factors against and reducing risk factors for infant obesity. METHOD: A 2 (Baby Healthy Living Triple P vs. care-as-usual) × 3 (baseline, postintervention, 6-month follow-up) design was used. Eighty-two parents of 4- to 18-month-old infants meeting at least two risk factors for early childhood obesity (e.g., parent/child overweight, low education level) were randomized to intervention (n = 42) or control group (n = 40). Parents questionnaires and child weight status was measured. RESULTS: Results showed an intervention effect on a primary outcome, early feeding practices (restrictive: d = 0.44, 95% CI [-0.01,0.88], pressuring: d = 0.11, 95% CI [-0.32,0.54], nonresponsive behaviors: (d = 0.32, 95% CI [-0.11,0.75]), and on a secondary outcome, feeding beliefs (d = 0.29, 95% CI [-0.14,0.73]). No beneficial impact was found on other primary outcomes (responsiveness in feeding: quantity d = 0.50, 95% CI [-0.03,1.03]) and nutritive d = 0.52, 95% CI [-0.03,1.07], mealtime environment: d = 0.35, 95% CI [-0.78,0.08], self-efficacy in responsive feeding: d = 0.21, 95% CI [-0.22,0.64]), or secondary outcomes (parental self-efficacy: d = 0.08, 95% CI [-0.50,0.35]), parent emotional eating (d = 0.01, 95% CI [-0.43,0.43]), food restraint (d = 0.42, 95% CI [-0.85,0.02]), and body satisfaction (d = 0.01, 95% CI [-0.43,0.43]) and child weight status (d = 0.11, 95% CI [-0.54,0.32]). CONCLUSIONS: Promising though limited support was demonstrated for a brief, low-intensity program to help parents in the prevention of obesity for infants at risk.

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BACKGROUND: Older Americans, a growing segment of the population, have an increasing need for surgical services, and they experience a disproportionate burden of postoperative complications compared to their younger counterparts. A preoperative comprehensive geriatric assessment (pCGA) is recommended to reduce risk and improve surgical care delivery for this population, which has been identified as vulnerable. The pCGA optimizes multiple chronic conditions and factors commonly overlooked in routine preoperative planning, including physical function, polypharmacy, nutrition, cognition, mental health, and social and environmental support. The pCGA has been shown to decrease postoperative morbidity, mortality, and length of stay in a variety of surgical specialties. Although national guidelines recommend the use of the pCGA, a paucity of strategic guidance for implementation limits its uptake to a few academic medical centers. By applying implementation science and human factors engineering methods, this study will provide the necessary evidence to optimize the implementation of the pCGA in a variety of health care settings. OBJECTIVE: The purpose of this paper is to describe the study protocol to design an adaptable, user-centered pCGA implementation package for use among older adults before major abdominal surgery. METHODS: This protocol uses systems engineering methods to develop, tailor, and pilot-test a user-centered pCGA implementation package, which can be adapted to community-based hospitals in preparation for a multisite implementation trial. The protocol is based upon the National Institutes of Health Stage Model for Behavioral Intervention Development and aligns with the goal to develop behavioral interventions with an eye to real-world implementation. In phase 1, we will use observation and interviews to map the pCGA process and identify system-based barriers and facilitators to its use among older adults undergoing major abdominal surgery. In phase 2, we will apply user-centered design methods, engaging health care providers, patients, and caregivers to co-design a pCGA implementation package. This package will be applicable to a diverse population of older patients undergoing major abdominal surgery at a large academic hospital and an affiliate community site. In phase 3, we will pilot-test and refine the pCGA implementation package in preparation for a future randomized controlled implementation-effectiveness trial. We anticipate that this study will take approximately 60 months (April 2023-March 2028). RESULTS: This study protocol will generate (1) a detailed process map of the pCGA; (2) an adaptable, user-centered pCGA implementation package ready for feasibility testing in a pilot trial; and (3) preliminary pilot data on the implementation and effectiveness of the package. We anticipate that these data will serve as the basis for future multisite hybrid implementation-effectiveness clinical trials of the pCGA in older adults undergoing major abdominal surgery. CONCLUSIONS: The expected results of this study will contribute to improving perioperative care processes for older adults before major abdominal surgery. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59428.

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INTRODUCTION: The popular traditional Chinese medicine (TCM) compound FYTF-919 (Zhong Feng Xing Nao prescription) may improve outcome from acute intracerebral hemorrhage (ICH) through effects on brain edema, hematoma absorption, and the immune system. This study is to assess whether FYTF-919 is safe and effective as compared to matching placebo treatment in patients with acute ICH. METHODS: The ongoing Chinese Herbal medicine in patients with Acute INtracerebral hemorrhage (CHAIN) is a multicenter, prospective, randomized, double-blind placebo-controlled trial of FYTF-919 in patients with acute ICH at 20-30 hospital sites in China. Eligible ICH patients presenting within 48 h after symptom onset are randomly allocated to receive either FYTF-919 (100 mL per day × 28 d, oral) or matching placebo. A sample size of 1,504 patients is estimated to provide 90% power (α 0.05) to detect a ≥20% improvement in average utility-weight scores on the modified Rankin scale (UW-mRS) assessed at 90 days, with 6% non-adherence and 10% lost to follow-up. The primary efficacy outcome is UW-mRS at 90 days. Secondary outcomes include binary measures of the mRS, neurological impairment on the National Institute of Health Stroke Scale, and health-related quality of life on the EuroQol EQ-5D-5L scale at different time points over 6 months of follow-up. The key safety measure is serious adverse events. CONCLUSION: CHAIN is on schedule to provide reliable evidence over the benefits of a popular herbal TCM for the treatment of acute ICH.

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BACKGROUND: Social participation as a protective factor against cognitive decline was one of the targets in the AgeWell.de study, a multi-domain interventional trial in a sample of older adults at increased risk for dementia. This study aimed to examine differential effects of the intervention and other influencing factors on social participation throughout the trial. METHODS: A longitudinal analysis of study data at the primary follow-up after 24 months (n = 819) was conducted. The Lubben Social Network Scale (LSNS-6) was used to assess quantitative aspects of social networks, and self-reported social activities were classified using a three-tiered categorical framework to capture qualitative aspects. RESULTS: A positive effect of the intervention was observed at the qualitative framework level, with an OR of 1.38 [95% CI: 1.05-1.82] for achieving or maintaining higher social participation at follow-up, while no effect could be detected on quantitative social network characteristics. Later phases of the Covid-19 pandemic showed a negative impact on the level of social participation at follow-up with an OR of 0.84 [95% CI: 0.75-0.95]. CONCLUSIONS: These findings suggest that by focusing on qualitative aspects of social participation as a component of dementia prevention, future interventions can promote enriched social interactions within established social networks. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) ID DRKS00013555.

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BACKGROUND: The progressive aging of the population has meant the increase in elderly patients requiring an urgent surgery. Older adults, especially those with frailty, have a higher risk for complications, functional and cognitive decline after urgent surgery. These patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. The consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, poor quality of life and increased use of resources related to health. We aim to determine whether postoperative physical rehabilitation can prevent functional and cognitive decline and modify the posterior trajectory. METHODS/DESIGN: This study is a randomized clinical trial, simple blinded, conducted in the Department of Surgery of a tertiary public hospital in Navarra (Hospital Universitario de Navarra), Spain. Patients > = 70 years old undergoing urgent abdominal surgery who meet inclusion criteria will be randomly assigned to the intervention or control group. The intervention will consist of a multicomponent physical training programme, which will include progressive and supervised endurance, resistance and balance training for 4 weeks, twice weekly sessions with a total of 8 sessions, and the group control will receive the usual care. The primary outcome measure is the change in functional (SPPB) and cognitive status (Mini-Mental State Examination) and the change of quality of life (EuroQol-5D-VAS) during the study period. The secondary outcomes are postoperative complications, length of stay, delirium, mortality, use of health resources, functional status (Barthel Index and handgrip strength tests), cost per quality-adjusted life year and mininutritional assessment. The data for both the intervention group and the control group will be obtained at four different times: the initial visit during hospital admission and at months 1, 3 and 6 months after hospital discharge. DISCUSSION: If our hypothesis is correct, this project could show that individualized and progressive exercise programme provides effective therapy for improving the functional capacity and achieve a better functional, cognitive and quality of life recovery. This measure, without entailing a significant expense for the administration, probably has an important repercussion both in the short- and long-term recovery, improving care and functional parameters and could determine a lower subsequent need for health resources. To verify this, we will carry out a cost-effectiveness study. The clinical impact of this trial can be significant if we help to modify the traditional management of the elderly patients from an illness model to a more person-centred and functionally oriented perspective. Moreover, the prescription of individualized exercise can be routinely included in the clinical practice of these patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05290532. Version 1. Registered on March 13, 2022.

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INTRODUCTION: Genetic testing is used across medical disciplines leading to unprecedented demand for genetic services. This has resulted in excessive waitlists and unsustainable pressure on the standard model of genetic healthcare. Alternative models are needed; e-health tools represent scalable and evidence-based solution. We aim to evaluate the effectiveness of the Genetics Navigator, an interactive patient-centred digital platform that supports the collection of medical and family history, provision of pregenetic and postgenetic counselling and return of genetic testing results across paediatric and adult settings. METHODS AND ANALYSIS: We will evaluate the effectiveness of the Genetics Navigator combined with usual care by a genetics clinician (physician or counsellor) to usual care alone in a randomised controlled trial. One hundred and thirty participants (adults patients or parents of paediatric patients) eligible for genetic testing through standard of care will be recruited across Ontario genetics clinics. Participants randomised into the intervention arm will use the Genetics Navigator for pretest and post-test genetic counselling and results disclosure in conjunction with their clinician. Participants randomised into the control arm will receive usual care, that is, clinician-delivered pretest and post-test genetic counselling, and results disclosure. The primary outcome is participant distress 2 weeks after test results disclosure. Secondary outcomes include knowledge, decisional conflict, anxiety, empowerment, quality of life, satisfaction, acceptability, digital health literacy and health resource use. Quantitative data will be analysed using statistical hypothesis tests and regression models. A subset of participants will be interviewed to explore user experience; data will be analysed using interpretive description. A cost-effectiveness analysis will examine the incremental cost of the Navigator compared with usual care per unit reduction in distress or unit improvement in quality of life from public payer and societal perspectives. ETHICS AND DISSEMINATION: This study was approved by Clinical Trials Ontario. Results will be shared through stakeholder workshops, national and international conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT06455384.

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PURPOSE: To compare the long-term outcomes of mucosal-sparing mechanical endoscopic dacryocystorhinostomy (MMED) for primary acquired nasolacrimal duct obstruction (PANDO) with or without silicone intubation. METHODS: An 11-year follow-up study of the Silicone intubation in Endoscopic Dacryocystorhinostomy (SEND) randomized controlled trial (RCT) was conducted at a university-affiliated dacryology clinic from December 2019 to March 2023. Questionnaires on symptoms, anterior segment examination, endoscopic examination with functional endoscopic dye test (FEDT) and FICI grading, and ostial size measurements using Image J software were performed by a masked ophthalmologist. The primary outcome was surgical success, defined by Munk's score ≤1 and a positive fluorescein endoscopic dye test. Secondary outcomes included risk factors for failure and outcomes of revision surgeries. RESULTS: Fifty-three of the original 118 patients were evaluated at 155 ± 21 (136-218) months postoperatively. Seventy-seven percent (46/60) ostia remained successful, including 70% (19/27) of unstented and 82% (27/33) of stented ostia (p = .3). Stented ostia had larger size (p = .003), but this did not confer higher success (p = .14). Successful ostia had higher FICI scores and better ostial dynamicity (p < .05). Ostium movement was the only parameter associated with surgical success on multivariate analysis (OR 13.1, p = .01). Four (1 stented) underwent revision MMED, intraoperative mitomycin-C, and 12-week intubation. All revision ostia were functional after 141 ± 43 months. CONCLUSIONS: Surgical success of MMED after 11-years was 77%, a notable reduction compared to 96% success at 1-year. Statistical advantage of silicone intubation for primary MMED was not demonstrated, though clinically, stented ostia had a higher success (82% vs 70%). The presence of a dynamic internal common opening was highly associated with long-term surgical success.

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BACKGROUND AND AIMS: Atrial fibrillation (AF) is a common arrhythmia, and many cases may be undiagnosed. It is unsettled whether screening for AF and subsequent treatment if AF is detected, can improve long-term outcome. The primary objective of the NORwegian atrial fibrillation self-SCREENing trial (NORSCREEN) is to assess whether self-screening for AF with continuous ECG for 3-7 days in individuals aged 65 years or older with at least one additional risk factor for stroke, and initiation of guideline-recommended therapy in patients with detected AF, will reduce the occurrence of stroke. METHODS: The study is a nationwide randomized, open, siteless, controlled trial. Individuals ≥65 years of age are randomly identified from the National Population Register of Norway and are invited to a digital inclusion/exclusion test. Individuals passing the inclusion/exclusion test are randomized to either the intervention group or the control group. A total of 35,000 participants will be enrolled. In the intervention group, self-screening is performed continuously over 3-7 days at home with a patch ECG device (ECG247) at inclusion and after 12-18 months. If AF is detected, guideline-recommended therapy will be initiated. Patients will be followed for five years through national health registries. The primary outcome is time to stroke. The first participant was enrolled in the NORSCREEN trial on September 1, 2023. CONCLUSIONS: The results from the NORSCREEN trial will provide new insight regarding the efficacy of digital siteless self-screening for AF with respect to stroke prevention in individuals at increased risk of stroke.

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BACKGROUND: Moderate to severe breast pain has major effects on the quality of life for patients. Patent Chinese medicines are widely used in the treatment of breast pain due to their stable dosage form and good efficacy. OBJECTIVE: To evaluate the beneficial effects and safety of Hongjin Xiaojie Capsule (HJXJC), a Chinese patent medicine, for the treatment of cyclical breast pain. DESIGN, SETTING, PARTICIPANTS AND INTERVENTION: This is a multicenter, single-blind randomized controlled trial conducted in 3 medical centers in China from 2019 to 2021. Patients with moderate to severe cyclic breast pain were randomly divided into the intervention group (who took HJXJC, four capsules per dose, three times a day for 12 weeks) and the control group (waiting for the treatment) in a 1:1 ratio. MAIN OUTCOME MEASURES: The primary outcome was pain duration, and the patients recorded measurements at baseline and at the end of weeks 4, 8, 12 and 16 on a patient log card. RESULTS: The full analysis set (FAS) population included 298 participants (intervention group, n = 150; control group, n = 148), while the per-protocol analysis set (PPS) included 274 participants. After 12 weeks, the duration of breast pain was significantly shorter in the intervention group (FAS: mean difference, -6.69; 95% CI, -7.58 to -5.80; P < 0.01, vs control. PPS: mean difference, -7.09; 95% CI, -8.01 to -6.16; P < 0.01, vs control). The Short-form McGill Pain Questionnaire (SF-MPQ) scores were significantly lower in the intervention group (FAS: mean difference, -12.55; 95% CI, -13.90 to -11.21; P < 0.01, vs control. PPS: mean difference, -13.07; 95% CI, -14.48 to -11.66; P < 0.01, vs control). The above indicators continued to be significantly different through week 16. Moreover, in the intervention group, breast lumps shrank after 12 weeks and the size of breast lumps was statistically smaller than that in the control group (P < 0.05), whereas the sizes of breast nodules and uterine fibroid showed no statistically significant difference compared with the control group (P > 0.05). At weeks 8 and 12, the dysmenorrhea scores in the intervention group were lower than those in the control group (P < 0.05). No obvious adverse reactions were observed in any group. CONCLUSION: HJXJC can significantly shorten the duration of breast pain, reduce breast pain, reduce the size of breast lumps, and relieve dysmenorrhea. However, it has no significant effect on the size of breast nodules or uterine fibroid. TRIAL REGISTRATION: This trial has been registered at the ISRCTN Registry. Number: ISRCTN44184398. PLEASE CITE THIS ARTICLE AS: Zhang Q, Fan YY, Wu XQ, Huo YD, Wang CH, Liang SB, Wang T, Zhong R, Wang X, Lai BY, Pei XH, Liu JP. Hongjin Xiaojie Capsule, a Chinese patent medicine, for treating moderate to severe cyclical breast pain: A single-blind randomized controlled trial. J Integr Med. 2024; Epub ahead of print.

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How to cite this article: Sundarsingh V, Kumar M. Emphasizing Patient-centered Outcomes and Improved Exclusion Criteria in Randomized Controlled Trials for Clinical Nutrition in Critically Ill Patients. Indian J Crit Care Med 2024;28(8):804-805.

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The European Larynx Organ Preservation Study (ELOS; NCT06137378) is a prospective, randomized, open-label, two-armed parallel group controlled, phase II multicenter larynx organ preservation (LOP) trial in locoregionally advanced (LA) stage III, IVA/B head and neck squamous cell carcinoma of the larynx or hypopharynx (LHSCC) amenable for total laryngectomy (TL) with PD-L1 expression within tumor tissue biopsy, calculated as CPS ≥ 1. Induction chemotherapy (IC) with docetaxel and cisplatin (TP) followed by radiation will be compared to TP plus PD-1 inhibition by pembrolizumab (MK-3475; 200 mg i.v. starting day 1 q3w for 17 cycles). After a short induction early response evaluation (ERE) 21 ± 3 days after the first cycle of IC (IC-1), responders achieving endoscopic estimated tumor surface shrinkage (ETSS) ≥30% will get an additional two cycles of IC followed by intensity-modulated radiotherapy 70-72 Gy (EQD2/α/ß = 10) aiming at LOP. Nonresponders (ETSS < 30% or progressing disease) will receive TL and bilateral neck dissection followed by postoperative radiation or chemoradiation as recommended by the clinic's multidisciplinary tumor board. Pembrolizumab treatment will be continued in the intervention arm regardless of ETSS status after IC-1 in both responders and laryngectomized nonresponders, independent of subsequent decisions on adjuvant therapy after TL. Clinical Trial Registration: clinicaltrials.gov, identifier NCT06137378.

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BACKGROUND: We estimated the short-term effects of an educational workshop and 10-week outdoor walk group (OWG) compared to the workshop and 10 weekly reminders (WR) on increasing outdoor walking (primary outcome) and walking capacity, health-promoting behavior, and successful aging defined by engagement in meaningful activities and well-being (secondary outcomes) in older adults with difficulty walking outdoors. METHODS: In a 4-site, parallel-group randomized controlled trial, two cohorts of community-living older adults (≥ 65 years) reporting difficulty walking outdoors participated. Following a 1-day workshop, participants were stratified and randomized to a 10-week OWG in parks or 10 telephone WR reinforcing workshop content. Masked evaluations occurred at 0, 3, and 5.5 months. We modeled minutes walked outdoors (derived from accelerometry and global positioning system data) using zero-inflated negative binomial regression with log link function, imputing for missing observations. We modeled non-imputed composite measures of walking capacity, health-promoting behavior, and successful aging using generalized linear models with general estimating equations based on a normal distribution and an unstructured correlation matrix. Analyses were adjusted for site, participation on own or with a partner, and cohort. RESULTS: We randomized 190 people to the OWG (n = 98) and WR interventions (n = 92). At 0, 3, and 5.5 months, median outdoor walking minutes was 22.56, 13.04, and 0 in the OWG, and 24.00, 26.07, and 0 in the WR group, respectively. There was no difference between groups in change from baseline in minutes walked outdoors based on incidence rate ratio (IRR) and 95% confidence interval (CI) at 3 months (IRR = 0.74, 95% CI 0.47, 1.14) and 5.5 months (IRR = 0.77, 95% CI 0.44, 1.34). Greater 0 to 3-month change in walking capacity was observed in the OWG compared to the WR group (ßz-scored difference = 0.14, 95% CI 0.02, 0.26) driven by significant improvement in walking self-efficacy; other comparisons were not significant. CONCLUSIONS: A group, park-based OWG was not superior to WR in increasing outdoor walking activity, health-promoting behavior or successful aging in older adults with difficulty walking outdoors; however, the OWG was superior to telephone WR in improving walking capacity through an increase in walking self-efficacy. Community implementation of the OWG is discussed. TRIAL REGISTRATION: ClinicalTrials.gov NCT03292510 Date of registration: September 25, 2017.

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OBJECTIVE: Resistance exercise is an effective strategy to improve muscle strength in older adults. A limited-load resistance would be flexible and suitable for community-based training. It was unclear whether high-frequency resistance exercise offer additional benefits to older adults. Here, we aimed to examine the effect of limited-load resistance exercise among different frequency on muscle parameters in older adults. METHODS: The current study was a single-blind, randomized controlled trial comparing the effectiveness of different-frequency resistance exercise in older adults. Change in skeletal muscle was estimated with a multi-frequency bioelectrical impedance analyzer. Demographics, physical examination, nutritional assessment, prealbumin and lymphocytes were also measured. Fisher's precision probability test and baseline-adjusted generalized linear models were applied accordingly to analyze the influence of dose-different exercise on prevalence of sarcopenia, muscle parameters and body composition. A two-sided p value of < 0.05 was defined statistical significance. RESULTS: The participants had a mean age of 71.96 years and close gender ratio. One hundred and twenty-seven participants (control 40; low-dose 46; high-dose 41) completed the 6-month exercise intervention. In contrast to control group, only high-dose exercise groups experienced improvements in muscle mass (0.66 kg, p < 0.001) and max grip strength (+ 2.17 kg, p < 0.001). There were significant dose-response effects of muscle mass (index), fat mass (index), max grip strength, 5-times sit to stand test, 6-minute walking test and visceral fat area (all ptrend <0.01). CONCLUSIONS: As the proved dose-dependent effect, current findings supported high-frequency limited-load resistance exercise applied and extended among older adults in community. TRIAL REGISTRATION: This study was registered at Chinese Clinical Trial Registry Network (ChiCTR2200062007, Registered on 19 July 2022).

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BACKGROUND: Higher cruciferous vegetable intake is associated with lower cardiovascular disease risk in observational studies. The pathways involved remain uncertain. We aimed to determine whether cruciferous vegetable intake (active) lowers 24-h brachial systolic blood pressure (SBP; primary outcome) compared to root and squash vegetables (control) in Australian adults with mildly elevated BP (SBP 120-160 mmHg inclusive). METHODS: In this randomized, controlled, crossover trial, participants completed two 2-week dietary interventions separated by a 2-week washout. Cruciferous vegetables were compared to root and squash vegetables (~ 300 g/day) consumed with lunch and dinner meals. Participants were blinded to which interventions were the active and control. Adherence was assessed using food diaries and biomarkers (S-methyl cysteine sulfoxide (SMCSO, active) and carotenoids (control)). Twenty-four-hour brachial ambulatory SBP and secondary outcomes were assessed pre- and post each intervention. Differences were tested using linear mixed effects regression. RESULTS: Eighteen participants were recruited (median (IQR) age: 68 (66-70); female: n = 16/18; mean ± SD clinic SBP: 135.9 ± 10.0 mmHg). For both interventions, 72% participants had 100% adherence (IQR: 96.4-100%). SMCSO and carotenoids were significantly different between interventions (mean difference active vs. control SMCSO: 22.93 mg/mL, 95%CI 15.62, 30.23, P < 0.0001; carotenoids: - 0.974 mg/mL, 95%CI - 1.525, - 0.423, P = 0.001). Twenty-four-hour brachial SBP was significantly reduced following the active vs. control (mean difference - 2.5 mmHg, 95%CI - 4.2, - 0.9, P = 0.002; active pre: 126.8 ± 12.6 mmHg, post: 124.4 ± 11.8 mmHg; control pre: 125.5 ± 12.1 mmHg, post: 124.8 ± 13.1 mmHg, n = 17), driven by daytime SBP (mean difference - 3.6 mmHg, 95%CI - 5.4, - 1.7, P < 0.001). Serum triglycerides were significantly lower following the active vs. control (mean difference - 0.2 mmol/L, 95%CI - 0.4, - 0.0, P = 0.047). CONCLUSIONS: Increased intake of cruciferous vegetables resulted in reduced SBP compared to root and squash vegetables. Future research is needed to determine whether targeted recommendations for increasing cruciferous vegetable intake benefits population health. TRIAL REGISTRATION: Clinical trial registry ACTRN12619001294145.  https://www.anzctr.org.au.

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