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Short-duration aerobic high-intensity intervals versus moderate exercise training intensity in patients with peripheral artery disease: study protocol for a randomised controlled trial (the Angiof-HIIT Study)

Por: Lanzi · S. · Pousaz · A. · Fresa · M. · Besson · C. · Desgraz · B. · Gremeaux-Bader · V. · Mazzolai · L.
Introduction

Supervised exercise training is among the first-line therapies for patients with peripheral artery disease (PAD). Current recommendations for exercise include guidance focusing on claudication pain, programme and session duration, and frequency. However, no guidance is offered regarding exercise training intensity. This study aims to compare the effects of 12-week-long supervised walking exercise training (high-intensity interval training (HIIT) vs moderate-intensity exercise (MOD)) in patients with chronic symptomatic PAD.

Methods and analysis

This study is a monocentric, interventional, non-blinded randomised controlled trial. 60 patients (30 in each group) will be randomly allocated (by using the random permuted blocks) to 12 weeks (three times a week) of HIIT or MOD. For HIIT, exercise sessions will consist of alternating brief high-intensity (≥85% of the peak heart rate (HRpeak)) periods (≤60 s) of work with periods of passive rest. Patients will be asked to complete 1 and then 2 sets of 5–7 (progressing to 10–15x60 s) walking intervals. For the MOD group, exercise training sessions will consist of an alternation of periods of work performed at moderate intensity (≤76% HRpeak) and periods of passive rest. Interventions will be matched by training load. The primary outcome will be the maximal walking distance. Secondary outcomes will include functional performance, functional capacity, heath-related quality of life, self-perceived walking abilities, physical activity and haemodynamic parameters.

Ethics and dissemination

The Angiof-HIIT Study was approved by the Human Research Ethics Committee of the Canton de Vaud (study number: 2022-01752). Written consent is mandatory prior to enrolment and randomisation. The results will be disseminated via national and international scientific meetings, scientific peer-reviewed journals and social media.

Trial registration number

NCT05612945.

Prevalence and short-term change in symptoms of anxiety and depression following bariatric surgery: a prospective cohort study

Objectives

Bariatric surgery is an effective treatment for severe obesity that leads to significant physical health improvements. Few studies have prospectively described the short-term impact of surgery on mental health using standardised case-finding measures for anxiety or depressive disorders. This study describes the prevalence and short-term course of these conditions following surgery.

Design

Prospective observational cohort study.

Setting

12 National Health Service centres in England.

Participants

Participants studied took part in the By-Band-Sleeve study, a multicentre randomised controlled trial evaluating the surgical management of severe obesity. We included participants who had undergone surgery (gastric bypass, gastric band or sleeve gastrectomy) within 6 months of randomisation.

Primary and secondary outcome measures

Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline and 12 months post-randomisation. Sociodemographic variables collected at prerandomisation included body mass index, age, sex, ethnicity, marital status, tobacco use, employment status and income band.

Results

In our sample of 758 participants, 94.5% (n 716) and 93.9% (n 712) had completed baseline anxiety (HADS-A) and depression (HADS-D) subscales. At pre-randomisation 46.1% (n 330/716, 95% CI 42.4% to 49.7%) met clinical case criteria for anxiety and 48.2% (n 343/712, 95% CI 44.5% to 51.8%) for depression. Among participants returning completed 12 months post-randomisation questionnaires (HADS-A n 503/716, HADS-D n 498/712), there was a significant reduction in the proportion of clinical cases with anxiety (–9.5%, 95% CI –14.3% to -4.8% p

Conclusions

Almost half of people undergoing bariatric surgery had underlying anxiety or depressive symptoms. In the short term, these symptoms appear to substantially improve. Future work must identify whether these effects are sustained beyond the first post-randomisation year.

Trial registration number

NCT02841527 and ISRCTN00786323.

Stakeholders perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a mixed methods study

Por: Deja · E. · Donohue · C. · Semple · M. G. · Woolfall · K. · for the BESS Investigators · Semple · McNamara · Allen · Fowler · Barker · Peak · Miert · Best · Donohue · Jones · Moitt · Price · Williamson · Clark · Madsen · Dawson · Summers · Deja · Woolfall · Osaghae · Turner · Panchal
Objectives

The Bronchiolitis Endotracheal Surfactant Study (BESS) is a randomised controlled trial to determine the efficacy of endo-tracheal surfactant therapy for critically ill infants with bronchiolitis. To explore acceptability of BESS, including approach to consent within a limited time frame, we explored parent and staff experiences of trial involvement in the first two bronchiolitis seasons to inform subsequent trial conduct.

Design

A mixed-method embedded study involving a site staff survey, questionnaires and interviews with parents approached about BESS.

Setting

Fourteen UK paediatric intensive care units.

Participants

Of the 179 parents of children approached to take part in BESS, 75 parents (of 69 children) took part in the embedded study. Of these, 55/69 (78%) completed a questionnaire, and 15/69 (21%) were interviewed. Thirty-eight staff completed a questionnaire.

Results

Parents and staff found the trial acceptable. All constructs of the Adapted Theoretical Framework of Acceptability were met. Parents viewed surfactant as being low risk and hoped their child’s participation would help others in the future. Although parents supported research without prior consent in studies of time critical interventions, they believed there was sufficient time to consider this trial. Parents recommended that prospective informed consent should continue to be sought for BESS. Many felt that the time between the consent process and intervention being administered took too long and should be ‘streamlined’ to avoid delays in administration of trial interventions. Staff described how the training and trial processes worked well, yet patients were missed due to lack of staff to deliver the intervention, particularly at weekends.

Conclusion

Parents and staff supported BESS trial and highlighted aspects of the protocol, which should be refined, including a streamlined informed consent process. Findings will be useful to inform proportionate approaches to consent in future paediatric trials where there is a short timeframe for consent discussions.

Trial registration number

ISRCTN11746266.

Lambs supplemented with Amazonian oilseed co-products: Meat quality and fatty acid profile

by Vinícius Costa Gomes de Castro, Juliana Cristina de Castro Budel, Thomaz Cyro Guimarães de Carvalho Rodrigues, Bruna Almeida Silva, Waléria Cristina Lopes Joset, Alyne Cristina Sodré de Lima, Shirley Motta Souza, Rui José Branquinho Bessa, Suzana Paula Almeida Alves, Jamile Andrea Rodrigues da Silva, Maria Regina Sarkis Peixoto Joele, André Guimarães Maciel e Silva, José de Brito Lourenço-Júnior

The Amazon has a wide variety of oilseeds that generate a huge amount of co-products with potential for use in animal nutrition. The objective was to use alternative resources (oilseed cakes) in the feeding of lambs to assign a sustainable destination to this biomass, and evaluate its influence on the quality and fatty acid (FA) profile of the meat. Twenty-four lambs, male, castrated, crossbred Dorper × Santa Inês, weighing 30 ± 1.3 kg of initial body weight, were distributed in a completely randomized design in 4 treatments (diets) with six replications (animals). The control diet (Control) contained corn and soybean meal as main ingredients, which were partially replaced in the other diets by cupuassu cake diet (Cup), palm kernel cake diet (Palm) and tucuma cake diet (Tuc). The inclusion of Amazon cakes influences the lipid (P = 0.02) and protein (P longissimus lumborum); reduces cooking losses (P 0.05). The inclusion of oilseed cakes influences the chemical composition, physical parameters, composition and fatty acid profile of the meat, but does not influence the indicators of atherogenicity, thrombogenicity and cholesterolemia.

Gender disparities, causes and predictors of immediate and short-term cardiovascular readmissions following COVID-19-related hospitalisations in the USA

Por: Vardar · U. · Shaka · H. · Kumi · D. · Gajjar · R. · Bess · O. · Kanemo · P. · Shaka · A. · Baskaran · N.
Objectives

In this study, we aimed to identify the causes, predictors and gender disparities of 30-day and 90-day cardiovascular readmissions after COVID-19-related hospitalisations using National Readmission Database (NRD) 2020.

Setting

We used the NRD from 2020 to identify hospitalised adults with a principal diagnosis of COVID-19 infection.

Participants

We included subjects who were readmitted within 30 days and 90 days after index admission. We excluded subjects with elective and traumatic admissions. We used a multivariate Cox regression model to identify independent predictors of readmission.

Primary and secondary outcomes measures

Our outcomes were inpatient mortality, 30-day and 90-day cardiovascular readmission rates following COVID-19 infection.

Results

During the study period, there were 1 024 492 index hospitalisations with a primary diagnosis of COVID-19 infection in the 2020 NRD database, 644 903 (62.9%) were included for 30-day readmission analysis, and 418 122 (40.8%) were included for 90-day readmission analysis. Of patients involved in the 30-day analysis, 7140 (1.1%) patients had a readmission within 30 days; of patients involved in the 90-day analysis, 8379 (2.0%) had a readmission within 90 days due to primarily cardiovascular causes. Cox regression analysis revealed that the female sex (aHR 0.89; 95% CI 0.82 to 0.95; p=0.001) was associated with a lower hazard of 30-day cardiovascular readmissions; however, congestive heart failure (aHR 2.45; 95% CI 2.2 to 2.72; p

Conclusion

Our study demonstrates that male gender, heart failure, arrhythmias and valvular disease carry higher hazards of 30-day and 90-day cardiovascular readmissions. Identifying risk factors and common causes of readmission may assist with lowering the burden of cardiovascular disease in patients with COVID-19 infection.

The Healthy Brain Initiative (HBI): A prospective cohort study protocol

by Lilah M. Besser, Stephanie Chrisphonte, Michael J. Kleiman, Deirdre O’Shea, Amie Rosenfeld, Magdalena Tolea, James E. Galvin

Background

The Health Brain Initiative (HBI), established by University of Miami’s Comprehensive Center for Brain Health (CCBH), follows racially/ethnically diverse older adults without dementia living in South Florida. With dementia prevention and brain health promotion as an overarching goal, HBI will advance scientific knowledge by developing novel assessments and non-invasive biomarkers of Alzheimer’s disease and related dementias (ADRD), examining additive effects of sociodemographic, lifestyle, neurological and biobehavioral measures, and employing innovative, methodologically advanced modeling methods to characterize ADRD risk and resilience factors and transition of brain aging.

Methods

HBI is a longitudinal, observational cohort study that will follow 500 deeply-phenotyped participants annually to collect, analyze, and store clinical, cognitive, behavioral, functional, genetic, and neuroimaging data and biospecimens. Participants are ≥50 years old; have no, subjective, or mild cognitive impairment; have a study partner; and are eligible to undergo magnetic resonance imaging (MRI). Recruitment is community-based including advertisements, word-of-mouth, community events, and physician referrals. At baseline, following informed consent, participants complete detailed web-based surveys (e.g., demographics, health history, risk and resilience factors), followed by two half-day visits which include neurological exams, cognitive and functional assessments, an overnight sleep study, and biospecimen collection. Structural and functional MRI is completed by all participants and a subset also consent to amyloid PET imaging. Annual follow-up visits repeat the same data and biospecimen collection as baseline, except that MRIs are conducted every other year after baseline.

Ethics and expected impact

HBI has been approved by the University of Miami Miller School of Medicine Institutional Review Board. Participants provide informed consent at baseline and are re-consented as needed with protocol changes. Data collected by HBI will lead to breakthroughs in developing new diagnostics and therapeutics, creating comprehensive diagnostic evaluations, and providing the evidence base for precision medicine approaches to dementia prevention with individualized treatment plans.

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