Key result
A planned randomized controlled feasibility trial will evaluate the delivery and preliminary efficacy of a personalized isometric wall squat exercise intervention for patients with Stage 1 hypertension in NHS primary care.
Why the study?
Adherence to recommended lifestyle advice and medication is poor, and before testing efficacy in a large trial, the feasibility of delivering personalized isometric exercise in NHS primary care needed to be assessed.
Does an isometric wall squat exercise intervention improve blood pressure and demonstrate feasibility of delivery in adults with Stage 1 hypertension?
RCT (n=100)
Open-label
Random permuted blocks within stratification (of site and age)
Yes
Does an isometric wall squat exercise intervention improve blood pressure and demonstrate feasibility of delivery in adults with Stage 1 hypertension?
This protocol describes a feasibility study to assess whether an isometric wall squat exercise intervention can be successfully delivered in NHS primary care for patients with Stage 1 hypertension.
Offers feasible BP-lowering option with potentially high adherence; extends non-pharmacological options for stage 1 hypertension beyond current guidelines.
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 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 success of intervention delivery and change in 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: 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: International Standard Randomised Controlled Trial Number (ISRCTN) 13472393 registered 18 August 2020. http://www.isrctn.com/ISRCTN13472393
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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 intervention delivery and variance of blood pressure changes from baseline. A planned randomized controlled feasibility trial will evaluate the delivery and preliminary efficacy of a personalized isometric wall squat exercise intervention for patients with Stage 1 hypertension in NHS primary care.
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