Title: Feasibility study to assess the delivery of a novel isometric exercise intervention for people with Stage 1 hypertension in the NHS.
Funder: Department of Health and Social Care

Abstract: Research Question: To determine the feasibility of delivering a personalised isometric exercise intervention for people with un-medicated Stage 1 hypertension in a primary care NHS setting. Background: Standard treatment of hypertension includes lifestyle modification and/or medication. Many people fail to control their blood pressure (BP) to within recommended ranges because they do not adhere to recommended interventions, particularly that of at least 150-minutes a week of moderate intensity activity. As little as 8-minutes of isometric (static muscle activity) exercise 3x weekly has consistently reduced BP in those with sub-optimal BP under laboratory and home-based conditions. This success is probably linked to the very short duration and accessibility of isometric exercise (IE). No studies have assessed the feasibility of prescribing IE using the validated wall squat protocol as a lifestyle intervention for Stage 1 hypertension in an NHS setting. Primary objectives: Assess if healthcare professionals can deliver the intervention in this setting. Determine the change of BP from baseline. Secondary objectives: Evidence the fidelity of the intervention. Determine short and medium-term adherence. Understand participant experiences. Determine recruitment and attrition rates to inform future trials. Explore the willingness of healthcare professionals to consider IE as a treatment option. Establish the cost and cost-utility of the IE intervention versus standard care for Stage 1 hypertension. Explore possible mechanisms of action and biomarkers for IE in reducing BP (further funding dependent). Methods: Patients (18 years and over with systolic BP 140-159mmHg) who are not taking anti-hypertensive medication and do not contravene exclusion criteria will be identified at GP sites and invited to participate. Following informed consent and home BP confirmation, participants will attend a GP surgery to confirm eligibility, provide baseline measures for BP and heart rate, complete diet, exercise/lifestyle and quality of life questionnaires, and provide an optional blood and urine sample. 100 participants will be randomised (1:1) to either Arm 1 (control) or Arm 2 (IE training intervention). All participants will be given standard care lifestyle advice. In addition to standard care, Arm 2 will receive an incremental IE test and an isometric wall squat training prescription to be undertaken 3x weekly for a minimum of 4-weeks. Following 4-weeks the same data will be collected (Visit 2). Participants will continue their treatment arm for another 5 months, requiring two further visits at 3 (Visit 3) and 6 months (Visit 4). Timelines for delivery: Pre-grant activity Oct-Dec 19; IE training package development and delivery Jan-Mar 20; Recruitment and data collection Apr 20-Mar 21; Data-analysis Mar-Apr 21; PPI co-production of project Oct 19-June 21; Outputs and dissemination Apr-June 21; Follow-on study and biological sample funding applications Jan 20-Mar 21. Anticipated Impact and Dissemination: We will establish the feasibility of delivering the IE wall squat protocol in primary care as a treatment option for Stage 1 hypertension. Results will inform sample size estimation for a large scale randomised controlled trial to determine the effect of this intervention upon resting blood pressure. Dissemination will occur via stakeholder liaison, lay summaries, conferences, media and scientific articles.

Lay abstract: High blood pressure (BP) affects 8 million people in the UK and increases the risk of other serious conditions such as stroke, heart attack and kidney disease. Consequently, the NHS spends more than &pound;1 billion per year on BP medication and an extra &pound;2 billion a year treating associated conditions. Standard treatment of high BP normally includes recommending changes in lifestyle (e.g. smoking/drinking alcohol/diet/exercise) and/or medication. However, 50-70% of patients fail to control their BP within recommended ranges because many do not adhere to medication prescriptions or adopt the recommended lifestyle changes. This is often due to the fact that medications are associated with unpleasant side effects or recommended levels of aerobic exercise (at least 150 minutes a week of moderate intensity activity) and dietary changes are difficult and time consuming to achieve. Evidence suggests that a particular type of exercise - isometric exercise - can lower BP more efficiently and with significantly less time and effort than aerobic exercise. Isometric exercise involves holding a fixed body position for a very short period. Studies have shown that 8 minutes of personalised isometric exercise, performed three times a week for 4 weeks can reduce BP in people with normal and slightly above normal BP. Our studies have shown that home-based isometric exercise, involving squatting with your back against a wall for 8 minutes, 3 times a week, is effective in reducing BP in people with normal or slightly raised BP. This feasibility study aims to confirm if isometric exercise can be prescribed to patients in the NHS, is beneficial and acceptable to patients and easily adhered to. Volunteers invited by their GP with high BP (not taking medication), will be randomly allocated to receive standard lifestyle advice alone, or standard lifestyle advice plus an isometric exercise programme. Volunteers will have their BP and heart rate taken before allocation, after 4 weeks, and 3 and 6 months to evaluate whether this intervention can be successfully delivered and what effect it may have on BP in this group. We will also explore patient experiences, adherence and how easily the isometric exercise programme can be delivered by NHS health professionals alongside the cost and value for money of the intervention in the NHS. This study was designed in consultation with patients and public; and is supported by patients and public co-applicants who will be part of the study team. The findings will benefit the large number of patients looking to manage high BP through lifestyle changes alone; and will be disseminated to lay audiences via a report and summaries accessible through NIHR, websites and media and to professionals through peer reviewed journals and presentations.

Research activity codes: 6.7 PHYSICAL
Health categories: CARDIOVASCULAR