Feasibility and Acceptability of Isometric Exercise and Lifestyle Change for the Management of Hypertension

NCT07213479 | Recruiting

• 1 other identifier: 10198
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension (HTN)

Keywords

Hypertension; Isometric Exercise; Wall Squat; Cardiovascular Disease; Lifestyle Change; Blood Pressure

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Office and Ambulatory Blood Pressure

  Baseline to 24 weeks.

Study Arms (2)

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.

Behavioral: Isometric Exercise and Lifestyle Change Advice

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.

Behavioral: Lifestyle Change Advice

Interventions

Lifestyle Change Advice BEHAVIORAL

Lifestyle change advice given as per current standard care for hypertension

Also known as: Behavioural Change

Lifestyle Change Control Group

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: * Bout 1: RPE 4 (target range: 3.5-4.5) * Bout 2: RPE 5.5 (target range: 5-6) * Bout 3: RPE 7 (target range: 6.5-7.5) * Bout 4: RPE 8.5 (target range: 8-9) If the RPE falls outside the target zone for a given bout, participants will adjust their squat height accordingly. 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

Also known as: Static Strength Training, Behaviour Change

Home Based Isometric Exercise and Lifestyle Change Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Arterial Hypertension (AH) in accordance with NICE guidelines.
• Under pharmacological treatment for AH with antihypertensive drug, type and dose maintained for the previous four months.
• Blood Pressure with values \<180 and \<110 mmHg for office systolic and diastolic BP, respectively.
• Not currently engaged in any structured or supervised exercise training programme, including resistance, aerobic, or isometric exercise, defined as planned exercise performed ≥2 times per week at moderate or greater intensity, for at least three months prior to enrolment.
• Written informed consent provided.

You may not qualify if:

• Body mass index \>35 kg/m2.
• Presence of cardiovascular disease beyond hypertension.
• Known orthopaedic, musculoskeletal, or neurological conditions that restrain isometric exercise execution.
• Presence of secondary hypertension
• Inability to follow verbal instructions or complete study protocol

Sponsors & Collaborators

• Northumbria University: lead
• HealthWorks Newcastle Upon Tyne: collaborator

Study Sites (1)

Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

RECRUITING

Related Publications (12)

• 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.

  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.

  PMID: 29133354 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.

  PMID: 32371787 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.

  PMID: 35089384 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.

  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.

  PMID: 37345492 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.

  PMID: 16702172 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.

  PMID: 32231128 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.

  PMID: 32001477 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.

  PMID: 35020458 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.

  PMID: 36180857 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.

  BACKGROUND

Related Links

• National Institute for Health and Care Excellence \[NICE\] (2019). Hypertension in adults: diagnosis and management
• Institute for Health Metrics and Evaluation (IHME). Global Burden of Disease 2021: Findings from the GBD 2021 Study
• Public Health England (2018). Tackling high blood pressure: an update

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gabriel Cucato, PhD

  Northumbria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Llewellyn, MSc

CONTACT

+447949026070; helen.llewellyn@northumbria.ac.uk

Gabriel Cucato, PhD

CONTACT

gabriel.cucato@northumbria.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: October 9, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)