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AnteayerBMJ Open

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.

Metformin in the prevention of type 2 diabetes after gestational diabetes in postnatal women (OMAhA): a UK multicentre randomised, placebo-controlled, double-blind feasibility trial with nested qualitative study

Por: Bolou · A. · Drymoussi · Z. · Lanz · D. · Amaefule · C. E. · Gonzalez Carreras · F. J. · Pardo Llorente · M. d. C. · Dodds · J. · Pizzo · E. · Thomas · A. · Heighway · J. · Harden · A. · Sanghi · A. · Hitman · G. · Zamora · J. · Perez · T. · Huda · M. S. B. · Thangaratinam · S.
Objective

To determine the feasibility of a definitive trial of metformin to prevent type 2 diabetes in the postnatal period in women with gestational diabetes.

Design

A multicentre, placebo-controlled, double-blind randomised feasibility trial with qualitative evaluation.

Setting

Three inner-city UK National Health Service hospitals in London.

Participants

Pregnant women with gestational diabetes treated with medication.

Interventions

2 g of metformin (intervention) or placebo (control) from delivery until 1 year postnatally.

Primary outcome measures

Rates of recruitment, randomisation, follow-up, attrition and adherence to the intervention.

Secondary outcome measures

Preliminary estimates of glycaemic effects, qualitative exploration, acceptability of the intervention and costs.

Results

Out of 302 eligible women, 57.9% (175/302) were recruited. We randomised 82.3% (144/175) of those recruited, with 71 women in the metformin group and 73 women in the placebo group. Of the participants remaining in the study and providing any adherence information, 54.1% (59/109) took at least 75% of the target intervention dose; the overall mean adherence was 64% (SD 33.6). Study procedures were found to be acceptable to women and healthcare professionals. An increased perceived risk of developing type 2 diabetes, or a positive experience of taking metformin during pregnancy, encouraged participation and adherence to the intervention. Barriers to adherence included disruption to the medication schedule caused by the washout periods ahead of each study visit or having insufficient daily reminders.

Conclusions

It is feasible to run a full-scale definitive trial on the effectiveness of metformin to prevent type 2 diabetes in women with gestational diabetes, during the early postnatal period. Adherence and engagement with the study could be improved with more regular reminders and potentially the addition of ongoing educational or peer support to reinforce messages around type 2 diabetes prevention.

Trial registration number

ISRCTN20930880.

Scabies outbreak management in refugee/migrant camps in Europe 2014-2017: a retrospective qualitative interview study of healthcare staff experiences and perspectives

Por: Richardson · N. A. · Cassell · J. A. · Head · M. G. · Lanza · S. · Schaefer · C. · Walker · S. L. · Middleton · J.
Objectives

Provide insights into the experiences and perspectives of healthcare staff who treated scabies or managed outbreaks in formal and informal refugee/migrant camps in Europe 2014–2017.

Design

Retrospective qualitative study using semistructured telephone interviews and framework analysis. Recruitment was done primarily through online networks of healthcare staff involved in medical care in refugee/migrant settings.

Setting

Formal and informal refugee/migrant camps in Europe 2014–2017.

Participants

Twelve participants (four doctors, four nurses, three allied health workers, one medical student) who had worked in camps (six in informal camps, nine in formal ones) across 15 locations within seven European countries (Greece, Serbia, Macedonia, Turkey, France, the Netherlands, Belgium).

Results

Participants reported that in camps they had worked, scabies diagnosis was primarily clinical (without dermatoscopy), and treatment and outbreak management varied highly. Seven stated scabicides were provided, while five reported that only symptomatic management was offered. They described camps as difficult places to work, with poor living standards for residents. Key perceived barriers to scabies control were (1) lack of water, sanitation and hygiene, specifically: absent/limited showers (difficult to wash off topical scabicides), and inability to wash clothes and bedding (may have increased transmission/reinfestation); (2) social factors: language, stigma, treatment non-compliance and mobility (interfering with contact tracing and follow-up treatments); (3) healthcare factors: scabicide shortages and diversity, lack of examination privacy and staff inexperience; (4) organisational factors: overcrowding, ineffective interorganisational coordination, and lack of support and maltreatment by state authorities (eg, not providing basic facilities, obstruction of self-care by camp residents and non-governmental organisation (NGO) aid).

Conclusions

We recommend development of accessible scabies guidelines for camps, use of consensus diagnostic criteria and oral ivermectin mass treatments. In addition, as much of the work described was by small, volunteer-staffed NGOs, we in the wider healthcare community should reflect how to better support such initiatives and those they serve.

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