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| Name | Class |
|---|---|
| HealthWorks Newcastle Upon Tyne | UNKNOWN |
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High blood pressure (hypertension) is a leading risk factor for cardiovascular diseases and may contribute to poor health and premature death. The purpose of this research is to learn if a home-based isometric exercise programme combined with lifestyle change advice is a practical and acceptable method for people diagnosed with hypertension to manage their condition. Isometric exercise involves a muscle contraction without movement of the limbs and previous research has shown this may be effective for reducing blood pressure. Therefore, this study will explore the experiences, thoughts, attitudes, and barriers to participation. It will also examine the effect the isometric exercise has on blood pressure.
Participants will undertake an isometric exercise programme using a wall squat position, 3 times per week, for 12 weeks. The exercise sessions will be completed at home with remote online supervision by an exercise professional. Lifestyle change advice will given in line with current guidelines to promote healthy behaviours to reduce high blood pressure. After 12 weeks, participants will be encouraged to continue with the wall squat exercise for a further 12-weeks unsupervised. Throughout the study, participants' blood pressure and daily activity will be recorded using a smartwatch device.
Upon completion of the intervention period, participants will be interviewed to gather their views and opinions on the isometric exercise programme. Changes in blood pressure will be evaluated at 12 and 24 weeks.
By exploring whether an isometric exercise programme is a feasible and acceptable method for hypertensive people to manage their condition and how this influences blood pressure, this research may aid in the development of a strategy to manage hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Based Isometric Exercise and Lifestyle Change Group | Experimental | Participants randomised to this group will undertake a remotely supervised 12-week home-based isometric exercise training intervention 3 times per week. The bilateral leg isometric exercise consists of 5-stage wall squat position determined by individual calculations at baseline. Rate of perceived exertion (RPE) will be monitored throughout the intervention and used to guide the squat stage position. Lifestyle change advice will be given in accordance with NICE guidelines for hypertension. Participants will receive a smartwatch (Huawei D2) to monitor their daily physical activity (step count) and record their home blood pressure. |
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| Lifestyle Change Control Group | Active Comparator | Participants randomised to this group will not receive any intervention other than lifestyle change advice in accordance with NICE guidelines for hypertension. Participants will receive a smartwatch (Huawei D2) to monitor their daily physical activity (step count) and record their home blood pressure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isometric Exercise and Lifestyle Change Advice | Behavioral | The intervention consists of two distinct phases: • Intensive Phase (12 weeks) - a structured, high-support period involving three weekly supervised isometric exercise sessions and lifestyle change advice. The supervised exercise programme will consist of 4 × 2-minute bouts of wall squat exercise, with 2-minute rest periods between bouts. Participant squat height position will be based on individual calculations determined at baseline. Target rate of perceived exertion (RPE) for each bout will be:
Lifestyle change advice will be given in booklet form in accordance with current NICE guidelines for hypertension. • Maintenance Phase (12-24 weeks) - focus on sustaining exercise and lifestyle behaviour changes |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Intervention | Feasibility will be determined by the rate of screening, eligibility, recruitment, and retention at 12 and 24 weeks. | Baseline to 24 weeks |
| Feasibility of Intervention | Feasibility will be determined by adherence to the intervention (number of sessions attended and completed) | Baseline to 24 weeks |
| Acceptability of Intervention | Participant acceptability will be determined through a qualitative process evaluation involving semi-structured interviews. The interviews will identify action mechanisms, examine experiences, barriers, facilitators, and behaviour change strategies, with a diverse sample to reflect varied demographics. Participants will be asked about their experience of participating in the study, thoughts, and attitudes towards the intervention. | Post 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Office and Ambulatory Blood Pressure | Blood pressure will be measured in mmHg via office and ambulatory methods. Office BP will be taken in a seated position in accordance with resting BP protocols. Ambulatory BP monitoring will be performed with a non-invasive oscillometric device placed on the nondominant arm and programmed to perform measurements every 15 minutes for 24 hours. The secondary outcome is the change in mmHg for systolic and diastolic blood pressure from baseline, 12 weeks, and 24 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helen Llewellyn, MSc | Contact | +447949026070 | helen.llewellyn@northumbria.ac.uk | |
| Gabriel Cucato, PhD | Contact | gabriel.cucato@northumbria.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Gabriel Cucato, PhD | Northumbria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northumbria University | Recruiting | Newcastle upon Tyne | NE1 8ST | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | World Health Organisation (2023). Global report on hypertension: the race against a silent killer. Report No.: ISBN 978-92-4-008106-2. Available from: https://www.who.int/publications/i/item/9789240081062. | ||
| 29133354 | Background | Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):1269-1324. doi: 10.1161/HYP.0000000000000066. Epub 2017 Nov 13. No abstract available. | |
| 32371787 |
| Label | URL |
|---|---|
| National Institute for Health and Care Excellence \[NICE\] (2019). Hypertension in adults: diagnosis and management | View source |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Individuals who meet the study criteria and agree to participate will be randomly assigned to one of two parallel groups: (1) home-based isometric exercise and lifestyle advice intervention, or (2) lifestyle advice control group. Randomisation will be performed with minimisation for sex and the mean of 24-hour ambulatory systolic BP (≤140 mm Hg vs >140 mm Hg).
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| Lifestyle Change Advice | Behavioral | Lifestyle change advice given as per current standard care for hypertension |
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| Baseline to 24 weeks. |
| Background |
| Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, Ramirez A, Schlaich M, Stergiou GS, Tomaszewski M, Wainford RD, Williams B, Schutte AE. 2020 International Society of Hypertension global hypertension practice guidelines. J Hypertens. 2020 Jun;38(6):982-1004. doi: 10.1097/HJH.0000000000002453. No abstract available. |
| 35089384 | Background | Swift HT, O'Driscoll JM, Coleman DD, Caux A, Wiles JD. Acute cardiac autonomic and haemodynamic responses to leg and arm isometric exercise. Eur J Appl Physiol. 2022 Apr;122(4):975-985. doi: 10.1007/s00421-022-04894-7. Epub 2022 Jan 28. |
| Background | Maisyaroh A., Putri D A., Abdillah A., & Widianto E P. (2021). The effect of isometric exercise on reducing blood pressure in people with hypertension: A literature review. Nurse and Health: Journal Keperawatan. 10(2): 162 - 174. |
| 37345492 | Background | Mancia G, Kreutz R, Brunstrom M, Burnier M, Grassi G, Januszewicz A, Muiesan ML, Tsioufis K, Agabiti-Rosei E, Algharably EAE, Azizi M, Benetos A, Borghi C, Hitij JB, Cifkova R, Coca A, Cornelissen V, Cruickshank JK, Cunha PG, Danser AHJ, Pinho RM, Delles C, Dominiczak AF, Dorobantu M, Doumas M, Fernandez-Alfonso MS, Halimi JM, Jarai Z, Jelakovic B, Jordan J, Kuznetsova T, Laurent S, Lovic D, Lurbe E, Mahfoud F, Manolis A, Miglinas M, Narkiewicz K, Niiranen T, Palatini P, Parati G, Pathak A, Persu A, Polonia J, Redon J, Sarafidis P, Schmieder R, Spronck B, Stabouli S, Stergiou G, Taddei S, Thomopoulos C, Tomaszewski M, Van de Borne P, Wanner C, Weber T, Williams B, Zhang ZY, Kjeldsen SE. 2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA). J Hypertens. 2023 Dec 1;41(12):1874-2071. doi: 10.1097/HJH.0000000000003480. Epub 2023 Sep 26. |
| 16702172 | Background | Luengo-Fernandez R, Leal J, Gray A, Petersen S, Rayner M. Cost of cardiovascular diseases in the United Kingdom. Heart. 2006 Oct;92(10):1384-9. doi: 10.1136/hrt.2005.072173. Epub 2006 May 15. |
| 32231128 | Background | Kounoupis A, Papadopoulos S, Galanis N, Dipla K, Zafeiridis A. Are Blood Pressure and Cardiovascular Stress Greater in Isometric or in Dynamic Resistance Exercise? Sports (Basel). 2020 Mar 28;8(4):41. doi: 10.3390/sports8040041. |
| 32001477 | Background | Jones NR, McCormack T, Constanti M, McManus RJ. Diagnosis and management of hypertension in adults: NICE guideline update 2019. Br J Gen Pract. 2020 Jan 30;70(691):90-91. doi: 10.3399/bjgp20X708053. Print 2020 Feb. No abstract available. |
| 35020458 | Background | O'Driscoll JM, Giorgione V, Edwards JJ, Wiles JD, Sharma R, Thilaganathan B. Myocardial Mechanics in Hypertensive Disorders of Pregnancy: a Systematic Review and Meta-Analysis. Hypertension. 2022 Feb;79(2):391-398. doi: 10.1161/HYPERTENSIONAHA.121.18123. Epub 2021 Nov 17. |
| 36180857 | Background | Bytyci Katanolli A, Probst-Hensch N, Ann Obas K, Gerold J, Zahorka M, Jerliu N, Ramadani Q, Fota N, Merten S. Perceived barriers to physical activity behaviour among patients with diabetes and hypertension in Kosovo: a qualitative study. BMC Prim Care. 2022 Sep 30;23(1):257. doi: 10.1186/s12875-022-01866-w. |
| Background | British Heart Foundation (2015). Cardiovascular Disease Statistics 2015: British Heart Foundation Centre on Population Approaches. Available from: https://www.bhf.org.uk/informationsupport/publications/statistics/cvd-stats-2015. |
| Institute for Health Metrics and Evaluation (IHME). Global Burden of Disease 2021: Findings from the GBD 2021 Study | View source |
| Public Health England (2018). Tackling high blood pressure: an update | View source |