Key result
A randomized controlled feasibility trial will evaluate the delivery of a personalized isometric wall squat exercise intervention and estimate the variance in systolic blood pressure change among 100 adults with stage 1 hypertension in NHS primary care.
Why the study?
Adherence to recommended lifestyle advice and medications is poor, and determining whether personalized isometric exercise can feasibly be delivered within NHS primary care was needed before larger trials.
Does isometric wall squat exercise added to standard lifestyle advice improve systolic blood pressure and prove feasible to deliver in adults with stage 1 hypertension?
RCT (n=100)
Open-label
Random permuted blocks within stratification (site and age)
Yes
Does isometric wall squat exercise added to standard lifestyle advice improve systolic blood pressure and prove feasible to deliver in adults with stage 1 hypertension?
This protocol outlines a feasibility study to determine if a personalized isometric exercise intervention can be effectively delivered in NHS primary care for patients with stage 1 hypertension.
Supports feasibility of home-based IE for stage 1 HTN; leaves open efficacy in definitive trials.
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.
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Wiles et al. (2021) conducted an RCT in Stage 1 hypertension (n=100). Isometric wall squat exercise vs. Standard care lifestyle advice was evaluated on Feasibility of healthcare professionals to deliver isometric exercise prescriptions in a primary care NHS setting and estimation of the variance of change in systolic blood pressure. A randomized controlled feasibility trial will evaluate the delivery of a personalized isometric wall squat exercise intervention and estimate the variance in systolic blood pressure change among 100 adults with stage 1 hypertension in NHS primary care.
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