Hypertension (HTN)NCT07213479
Feasibility and Acceptability of Isometric Exercise and Lifestyle Change for the Management of Hypertension
A study testing Isometric Exercise and Lifestyle Change Advice and Lifestyle Change Advice in people with Hypertension (HTN), run by Northumbria University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension (HTN)
- What is being tested?
- Isometric Exercise and Lifestyle Change Advice and Lifestyle Change Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Feb 2026to Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. Participants may engage in habitual physical activity; however, those meeting current physical activity recommendations (≥150 min·week-¹ of moderate-intensity or ≥75 min·week-¹ of vigorous-intensity activity, or an equivalent combination) will be excluded. Physical activity levels will be ascertained using the International Physical Activity Questionnaire (IPAQ).
- Written informed consent provided.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gabriel Cucato, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Northumbria University
Newcastle upon Tyne, NE1 8ST
Helen Llewellyn, MSc
About this study
Official title: Feasibility and Acceptability of Remote Home-Based Isometric Exercise and Lifestyle Change for the Management of Hypertension
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.
Read more
Upon completion of the study, participants will be interviewed to gather their views and opinions on the programme. Changes in blood pressure will be evaluated at 12 and 24 weeks.
By exploring whether lifestyle advice and 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)
- Being tested
- Isometric Exercise and Lifestyle Change Advice, Lifestyle Change Advice
- Keywords
- Hypertension, Isometric Exercise, Wall Squat, Cardiovascular Disease, Lifestyle Change, Blood Pressure
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric Exercise and Lifestyle Change AdviceBehavioural
Also called Static Strength Training, Behaviour Change
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
Lifestyle Change AdviceBehavioural
Also called Behavioural Change
Lifestyle change advice given as per current standard care for hypertension
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Lifestyle Change Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention
Feasibility will be determined by the rate of screening, eligibility, recruitment, and retention at 12 and 24 weeks.
Measured: Baseline to 24 weeks
Feasibility of Intervention
Feasibility will be determined by adherence to the intervention (number of sessions attended and completed)
Measured: Baseline to 24 weeks
Acceptability of Intervention
Participant acceptability will be determined through a qualitative process evaluation involving semi-structured interviews. The interviews will explore experience with study participation (informed consent process, time commitment), the acceptability of measures (readability, burden), and experiences, thoughts, and attitudes toward current usual care.
Measured: Post 24 weeks
Secondary outcomes (1)
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.
Measured: Baseline to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start2 Feb 2026
- Primary completionAug 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 office systolic BP (≤140 mm Hg vs \>140 mm Hg).
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- HealthWorks Newcastle Upon Tyne
- Responsible party
- Sponsor
- Investigators
- Gabriel Cucato, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213479
- Sponsor's protocol ID
- 10198
- Status last verified
- Jan 2026
- First submitted
- 4 Sep 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 29133354Unger 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.
PubMed 32371787Swift 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.
PubMed 35089384Maisyaroh 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.
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.
PubMed 37345492Luengo-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.
PubMed 16702172Kounoupis 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.
PubMed 32231128Jones 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.
PubMed 32001477O'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.
PubMed 35020458Bytyci 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.
PubMed 36180857British 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.
Llewellyn H, Audsley S, Court P, Rodrigues A, Neto EW, Cucato GG. Evaluating the feasibility and acceptability of home-based isometric exercise and behaviour change for the management of hypertension: The HOME-FIT study protocol. PLoS One. 2026 Jul 10;21(7):e0353111. doi: 10.1371/journal.pone.0353111. eCollection 2026.
PubMed 42430325