Isofitter Research Trial
Title: Randomised controlled effectiveness trial (RCT) of isometric exercise (IE) in adults with stage 1 and 2 hypertension.
Aim of the research: We are recruiting ~500 participants across NHS primary and community services alongside direct to participant recruitment to confirm if wall-squat isometric exercise (IE) training will reduce resting blood pressure (BP) in people with Stage 1 and 2 hypertension. IE involves holding a fixed position for a short period of
time. IE could benefit the many patients looking to manage high BP through lifestyle changes.
Background to the research: High BP affects more than one in four adults in England and only one in three patients are being treated effectively.
The cost of not being treated effectively is approximately £2.1 billion per year, mainly due to care related to strokes and heart attacks. Treatment of high BP includes changes to lifestyle such as more physical activity and/or taking medication. Unfortunately, >50% of hypertensives fail to reduce their BP to healthier levels as they do not fully adopt treatment. Evidence suggests that IE can lower BP a greater amount with less time and effort than the other types of exercise currently recommended. Studies have shown that eight-minutes of personalised IE, performed three times a week for four-weeks can reduce resting BP significantly in unmedicated people.
This study follows preliminary research by the same research team which considered if wall-squat IE (squatting with your back against the wall) could be delivered in the NHS. Results found that participants easily achieved and enjoyed the exercise at home. Healthcare professionals also thought it was an achievable intervention. This IE has since been developed for patients to exercise at home without any involvement from a healthcare professional (self-delivered). A larger study is now underway to confirm if this IE results in consistent reduction in people's BP.
Design and methods used: Recruits will be 18 years or older with a high BP diagnosis and without any complex health conditions. We will use a broad approach to ask people to take part, including those from underserved groups. This will include advertising on social media, through community settings, GP surgeries, hospitals and pharmacies. We will give all participants a BP monitor and healthy lifestyle advice and ask them to
record their BP at four-weeks, three-months and six-months. Half the participants will be
randomly enrolled onto an IE training programme for six-months. This involves completing three IE wall-squat sessions per week, taking less than fifteen minutes each time.
Patient and Public Involvement: We designed this study with patient/public contributors and have continued support from three public co-applicants who are part of the study team.
Dissemination: We will give a summary of results to participants and lay audiences via social media and websites, including our charity partner organisation Blood Pressure UK. We will inform professionals through journals and conferences. The research may inform policy makers to consider including IE in physical activity guidelines.
Inclusion criteria:
• aged 18+
• stage 1 or 2 hypertension (≥140/90 -179/119mmHg) that has been diagnosed by a health
care professional and confirmed by GP
• able to undertake an IE intervention
• able to self-monitor BP
• prescribed no more than 1 anti-hypertensive agent.
Exclusion criteria:
• Alteration to antihypertensive medications (either dose or number of medications) within 6 weeks prior to screening
• Receiving a β-blocker
• Averaged home SBP <120 mmHg following 3 days screening
• Ischaemic heart disease, stroke or transient ischaemic attack in the past 3-months
• moderate or severe valvular heart disease, atrial or ventricular arrhythmia, congenital or inherited heart condition
• Pregnancy or actively trying to conceive
• enrolled in CTIMP/device/other interventional study of BP.
• Any condition that would be made worse by doing the wall squat exercise.
Register to take part
To check your eligibility and register your interest click here