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

Abstract 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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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

10.21203/rs.3.rs-149399/v1 ◽

2021 ◽

Author(s):

Jonathan Wiles ◽

Melanie Rees-Roberts ◽

Jamie O’Driscoll ◽

Timothy Doulton ◽

Douglas McInnes ◽

...

Keyword(s):

Primary Care ◽

Randomised Controlled Trial ◽

Feasibility Study ◽

Controlled Trial ◽

Isometric Exercise ◽

Lifestyle Changes ◽

Lifestyle Advice ◽

Alternative Treatment Option ◽

Randomised Controlled ◽

Stage 1

Abstract 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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Safety in primary care (SAP-C): a randomised, controlled feasibility study in two different healthcare systems

BMC Family Practice ◽

10.1186/s12875-019-0909-8 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Caoimhe Madden ◽

Sinéad Lydon ◽

Margaret E. Cupples ◽

Nigel D. Hart ◽

Ciara Curran ◽

...

Keyword(s):

Primary Care ◽

Feasibility Study ◽

Healthcare Systems ◽

Randomised Controlled

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Acceptability of the “MOVEdiabetes” physical activity intervention in diabetes primary care settings in Oman: findings from participants and practitioners

BMC Public Health ◽

10.1186/s12889-020-09029-1 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Thamra S. Alghafri ◽

Saud M. Al Harthi ◽

Fatma Al-Ajmi ◽

Yahya Al-Farsi ◽

Angela M. Craigie ◽

...

Keyword(s):

Physical Activity ◽

Primary Care ◽

Diabetes Management ◽

Physical Activity Intervention ◽

Retention Rate ◽

Intervention Group ◽

Randomised Control Trial ◽

Dietary Advice ◽

Intervention Programme ◽

Randomised Controlled

Abstract Background Adequate physical activity (PA) is considered essential in diabetes management. However, evidence on the best method of promoting PA within diabetes care is inconclusive. The current work identifies perceptions on the acceptability of Intervention Group Participants (IGP) and Project Officers (POs) about the “MOVEdiabetes” intervention programme aimed at increasing PA in adults with type 2 diabetes in Oman (a retrospectively registered trial). Methods The “MOVEdiabetes” programme (PA consultations, pedometers and WhatsApp messages) was delivered by the POs (primary health care practitioners) in four primary care centres within a one-year cluster randomised control trial. Recruitment and retention were measured from trial attendance records. Programme satisfaction, appropriateness, and content suitability were assessed using exit surveys for both the IGP (interview based) and POs (self-administered). Open text questions on perceptions to the study programme were also included. Results Participants were randomised to an intervention group (IG, n = 122) or comparison group (CG, n = 110). The overall retention rate at three and 12 months was 92.7% [110(90.2%) IG vs 105(95.5%) CG] and 75% [82(67.2%) IG vs 92(83.6%) CG] respectively. Most (n = 14, 87.5%) POs and more than half (n = 49, 59.8%) IGP perceived the programme as very appropriate and many reported that they were “quite/ very satisfied” with the programme (n = 16, 100% PO’s and n = 71, 86.6% IGP). Two thirds (n = 55, 66.0%) of IGP were very/quite likely to recommend the programme to others. PA consultations, use of pedometers and Whatsapp messages were well perceived by all. Participants recommended the inclusion of dietary advice and PA promotion for the general public. Exploring PA facilities within the community was suggested by POs. Conclusions The “MOVEdiabetes” programme achieved a high retention rate and was perceived as satisfactory and appropriate. Results from this study suggest that it is worthwhile exploring the use of the “MOVEdiabetes” programme in clinical practice and further community links. Trial registration International Standard Randomised Controlled Trials No: ISRCTN14425284. Registered retrospectively on 12th April 2016.

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