Experiences, acceptability and feasibility of an isometric exercise intervention for stage 1 hypertension: embedded qualitative study in a randomised controlled feasibility trial.

BACKGROUND: Healthy lifestyle changes for patients with stage 1 hypertension are recommended before antihypertensive medication. Exercise has antihypertensive benefits; however, low adoption and high attrition are common. Patients need easily adoptable, effective and manageable exercise interventions that can be sustained for life. We present participant and stakeholder perceptions of an isometric exercise intervention for stage 1 hypertension delivered in the National Health Service (NHS, UK). METHODS: An embedded qualitative study within a randomised-controlled feasibility study included intervention arm participants (n = 10), healthcare professionals from participating NHS sites (n = 3) and non-participating NHS sites (n = 5) taking part in semi-structured interviews to explore feasibility of delivering an isometric exercise intervention within the study design and an NHS context. Data was analysed using reflective thematic analysis. RESULTS: Three themes were identified: study deliverability; motivators and barriers; support for study participation. Findings indicated that the study was well designed. Health benefits, unwillingness to take medication, altruism and interest in the study helped motivation and adherence. Study support received was good, but healthcare professionals were insecure in intervention delivery with regular training/supervision needed. Perception of health improvement was mixed, but, in some, uptake of wider lifestyle changes resulted from participation. Stakeholders felt that current service challenges/demand would make implementation challenging. CONCLUSIONS: Despite participant positivity, delivery of an isometric intervention in an NHS setting was considered challenging given the current service demand, although possible with robust effectiveness evidence. Findings support further effectiveness data and implementation development of the isometric exercise intervention. TRIAL REGISTRATION: ISRCTN, ISRCTN13472393 . Registered 18 September 2020.

Delivering clinical studies of exercise in the COVID-19 pandemic: challenges and adaptations using a feasibility trial of isometric exercise to treat hypertension as an exemplar.

The COVID-19 pandemic has significantly impacted on the delivery of clinical trials in the UK, posing complicated organisational challenges and requiring adaptations, especially to exercise intervention studies based in the community. We aim to identify the challenges of public involvement, recruitment, consent, follow-up, intervention and the healthcare professional delivery aspects of a feasibility study of exercise in hypertensive primary care patients during the COVID-19 pandemic. While these challenges elicited many reactive changes which were specific to, and only relevant in the context of 'lockdown' requirements, some of the protocol developments that came about during this unprecedented period have great potential to inform more permanent practices for carrying out this type of research. To this end, we detail the necessary adaptations to many elements of the feasibility study and critically reflect on our approach to redesigning and amending this ongoing project in order to maintain its viability to date. Some of the more major protocol adaptations, such as moving the study to remote means wherever possible, had further unforeseen and undesirable outcomes (eg, additional appointments) with regards to extra resources required to deliver the study. However, other changes improved the efficiency of the study, such as the remote informed consent and the direct advertising with prescreening survey. The adaptations to the study have clear links to the UK Plan for the future of research delivery. It is intended that this specific documentation and critical evaluation will help those planning or delivering similar studies to do so in a more resource efficient and effective way. In conclusion, it is essential to reflect and respond with protocol changes in the current climate in order to deliver clinical research successfully, as in the case of this particular study.

Feasibility study to assess the delivery of a novel isometric exercise intervention for people with stage 1 hypertension in the NHS: protocol for the IsoFIT-BP study including amendments to mitigate the risk of COVID-19.

BACKGROUND: Hypertension  (HTN) affects approximately 25% of the UK population and is a leading cause of mortality. Associated annual health care costs run into billions. National treatment guidance includes initial lifestyle advice, followed by anti-hypertensive medication if blood pressure (BP) remains high. However, adoption and adherence to recommended exercise guidelines, dietary advice and anti-hypertensive medication is poor. Four short bouts of isometric exercise (IE) performed 3 days per week (d/wk) at home elicits clinically significant reductions in BP in those with normal to high-normal BP. This study will determine the feasibility of delivering personalised IE to patients with stage 1 hypertension for whom lifestyle changes would be recommended before medication within NHS primary care. METHODS: This is a randomised controlled feasibility study. Participants were 18+ years, with stage 1 hypertension, not on anti-hypertensive medication and without significant medical contraindications. Trial arms will be standard lifestyle advice (control) or isometric wall squat exercise and standard lifestyle advice. Primary outcomes include the feasibility of healthcare professionals to deliver isometric exercise prescriptions in a primary care NHS setting and estimation of the variance of change in systolic BP. Secondary outcomes include accuracy of protocol delivery, execution of and adherence to protocol, recruitment rate, attrition, perception of intervention viability, cost, participant experience and accuracy of home BP. The study will last 18 months. Sample size of 100 participants (50 per arm) allows for 20% attrition and 6.5% incomplete data, based upon 74 (37 each arm) participants (two-sided 95% confidence interval, width of 1.33 and standard deviation of 4) completing 4 weeks. Ethical approval IRAS ID is 274676. DISCUSSION: Before the efficacy of this novel intervention to treat stage 1 hypertension can be investigated in any large randomised controlled trial, it is necessary to ascertain if it can be delivered and carried out in a NHS primary care setting. Findings could support IE viability as a prophylactic/alternative treatment option. TRIAL REGISTRATION: ISRCTN13472393 , registered 18 August 2020.