HypertensionPhase 3NCT07251920
Isometric Resistance Training and Dose-dependent Effects in Pre- and Hypertensive Adults
A Phase 3 study testing Isometric resistance training in people with Hypertension and Blood Pressure, High, run by The University of Northampton at 1 site in United Kingdom.
Trial summary
High blood pressure is prevalent in a third of the global population and is a key risk factor for cardiovascular disease, the leading cause of death. one lifestyle change that is recommended to reduce blood pressure is to exercise, typically by performing aerobic exercise, but this is often not well adhered to, given… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypertension, Blood Pressure, High
- What is being tested?
- Isometric resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Feb 2024to 21 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- not taking anti-hypertensive medication
- borderlerine hypertensive or hypertensive (systolic blood pressure >139 mmHG, diastolic blood pressure > 89 mmHg
Who cannot join
- conditoned to resistance training
- currently taking anti-hypertensive medication
- regularly smoke or vape
- are pregnant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Northampton, Waterside Campus
Northampton, Northamptonshire, NN1 5PH
About this study
Official title: Examination of the Dose-dependent Effects of Isometric Resistance Training on Decreases in Blood Pressure in Pre- and Hypertensive Adults
High blood pressure is prevalent in a third of the global population and is a key risk factor for cardiovascular disease, the leading cause of death. one lifestyle change that is recommended to reduce blood pressure is to exercise, typically by performing aerobic exercise, but this is often not well adhered to, given the physical and time demands associated with it. Isometric resistance training has been evidenced as an efficacious method to reduce blood pressure, even when performing four two-minute contractions per day, three days per week at 30% of maximum effort. At present, the dose-response effects have not been examined, which are required to identify the minimal effective dose, which could further reduce the temporal demands of this modality to potentially enhance adhernece even more in time-anxious individuals. Therefore, this study aimed to compare the efficacy of once- twice-, and thrice-weekly isometric resistance training programmes to lower blood pressure,
Read the detailed description
The World Health Organisation have reported hypertension, a major risk factor for cardiovascular disease (CVD), strokes and coronary heart disease (CHD), to be near epidemic levels globally with over 30% of the world's population, at this time, suffering from hypertension. Over the past twenty years isometric resistance training (IRT) has been established as one of the best forms of nonpharmacological interventions for the prevention and treatment of hypertension and endorsed by the American College of Cardiology / American Heart Association in their most recent guidelines. Thrice weekly IRT programmes undertaken (4 x 2-minute isometric contractions) at 20-30% of an individual's maximum voluntary contraction (MVC) for a period of 4-10 weeks have demonstrated reductions in clinic resting and ambulatory systolic blood pressure (-4 to -10 mmHg), in both normotensive and hypertensive men and women with no reported difference in the magnitude of these reductions between women and men.
Whilst isometric training has been shown to produce clinically meaningful reductions in blood pressure, utilising the commonly used protocol (4 x 2-min contractions) three-times a week, one of the main barriers to therapeutic exercise interventions is time to undertake the intervention and despite the observed benefits, adherence and compliance tends to be low. Indeed, regular exercise adherence declines over time, with only 50% of individuals continuing with regular exercise within the first twelve months following the completion of a therapeutic treatment, with a lack of perceived time cited as one of the main barriers. With this in mind, it is important to determine the effects of training dose on the changes in blood pressure seen following IRT. To date there is very little research into the effects of IRT dose on resting blood pressure with only one study purposely investigated the area. Whilst to the authors knowledge no studies have investigated the effects of altered training dose on ambulatory or diurnal blood pressure variations. Although three times a week has become the most commonly applied protocol there is no evidence to confirm that it is the most efficacious. As training dose is an important determinant of adaptations to exercise training, and with a lack of time cited as a perceived barrier to undertaking exercise, there is a need to determine the most efficacious training protocol to elicit clinical reductions in blood pressure, including shorter time saving (once or twice weekly) protocols.
Therefore, the study aims are to determine if a reduction in the weekly dose of isometric training, such as a reduction in the number of total contractions and therefore a reduced time commitment (once or twice weekly) would produce a similar hypotensive response to those reported.
- Conditions
- Hypertension, Blood Pressure, High
- Being tested
- Isometric resistance training
- Keywords
- Hypertension, Blood pressure, Isometric contraction, Isometric resistance training, Isometric exercise
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric resistance trainingOther
isometric resistance training was performed on the chest, arms, and leg muscle groups using a band. Each contraction, was pulled at a perceived 30% (using a CR10 perceieved exertion rating scale) of maximum effort for 2 minutes; one repetition was performed using each muscle group. Weekly frequnecy changed between groups, ranging from once to thrice per week.
| Study group | Role | What they receive |
|---|---|---|
| Once-weekly training | Experimental | Performed isometric resistance training once per week (four 2-minute contractions). Receives: Other: Isometric resistance training |
| Twice-weekly training | Experimental | Performed isometric resistance training twice per week (eight 2-minute contractions). Receives: Other: Isometric resistance training |
| Thrice-weekly training | Active comparator | Performed isometric resistance training thrice per week (12 2-minute contractions). Receives: Other: Isometric resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory blood pressure
Blood pressure assessed during a 24-hour window
Measured: Through study completion (12 weeks)
Secondary outcomes (1)
Resting blood pressure
Blood pressure taken following a 10-minute rest period
Measured: Through study completion (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start19 Feb 2024
- Primary completion20 May 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Northampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251920
- Sponsor's protocol ID
- FREC2324002
- Status last verified
- Jan 2024
- First submitted
- 18 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be uplaoded to a reposiotory hosted by The University of Northampton and will be publicly available online. The DOI and URL to the data set will be included in future publications.
Publications
Smart NA, Way D, Carlson D, Millar P, McGowan C, Swaine I, Baross A, Howden R, Ritti-Dias R, Wiles J, Cornelissen V, Gordon B, Taylor R, Bleile B. Effects of isometric resistance training on resting blood pressure: individual participant data meta-analysis. J Hypertens. 2019 Oct;37(10):1927-1938. doi: 10.1097/HJH.0000000000002105.
PubMed 30889048Lopes S, Felix G, Mesquita-Bastos J, Figueiredo D, Oliveira J, Ribeiro F. Determinants of exercise adherence and maintenance among patients with hypertension: a narrative review. Rev Cardiovasc Med. 2021 Dec 22;22(4):1271-1278. doi: 10.31083/j.rcm2204134.
PubMed 34957769Zhou B, Perel P, Mensah GA, Ezzati M. Global epidemiology, health burden and effective interventions for elevated blood pressure and hypertension. Nat Rev Cardiol. 2021 Nov;18(11):785-802. doi: 10.1038/s41569-021-00559-8. Epub 2021 May 28.
PubMed 34050340Garcia-Hermoso A, Lopez-Gil JF, Ramirez-Velez R, Alonso-Martinez AM, Izquierdo M, Ezzatvar Y. Adherence to aerobic and muscle-strengthening activities guidelines: a systematic review and meta-analysis of 3.3 million participants across 32 countries. Br J Sports Med. 2023 Feb;57(4):225-229. doi: 10.1136/bjsports-2022-106189. Epub 2022 Nov 23.
PubMed 36418149
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Dose-dependent Effects of Isometric Resistance Training on Decreases in Blood Pressure in Pre- and Hypertensive Adults
- ClinicalTrials.gov ID
- NCT07251920
- Acronym / sponsor ID
- FREC2324002
- Conditions
- Hypertension, Blood Pressure, High
- Keywords
- Hypertension, Blood pressure, Isometric contraction, Isometric resistance training, Isometric exercise
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of NorthamptonUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High blood pressure is prevalent in a third of the global population and is a key risk factor for cardiovascular disease, the leading cause of death. one lifestyle change that is recommended to reduce blood pressure is to exercise, typically by performing aerobic exercise, but this is often not well adhered to, given the physical and time demands associated with it. Isometric resistance training has been evidenced as an efficacious method to reduce blood pressure, even when performing four two-minute contractions per day, three days per week at 30% of maximum effort. At present, the dose-response effects have not been examined, which are required to identify the minimal effective dose, which could further reduce the temporal demands of this modality to potentially enhance adhernece even more in time-anxious individuals. Therefore, this study aimed to compare the efficacy of once- twice-, and thrice-weekly isometric resistance training programmes to lower blood pressure,
Detailed description
The World Health Organisation have reported hypertension, a major risk factor for cardiovascular disease (CVD), strokes and coronary heart disease (CHD), to be near epidemic levels globally with over 30% of the world's population, at this time, suffering from hypertension. Over the past twenty years isometric resistance training (IRT) has been established as one of the best forms of nonpharmacological interventions for the prevention and treatment of hypertension and endorsed by the American College of Cardiology / American Heart Association in their most recent guidelines. Thrice weekly IRT programmes undertaken (4 x 2-minute isometric contractions) at 20-30% of an individual's maximum voluntary contraction (MVC) for a period of 4-10 weeks have demonstrated reductions in clinic resting and ambulatory systolic blood pressure (-4 to -10 mmHg), in both normotensive and hypertensive men and women with no reported difference in the magnitude of these reductions between women and men.
Whilst isometric training has been shown to produce clinically meaningful reductions in blood pressure, utilising the commonly used protocol (4 x 2-min contractions) three-times a week, one of the main barriers to therapeutic exercise interventions is time to undertake the intervention and despite the observed benefits, adherence and compliance tends to be low. Indeed, regular exercise adherence declines over time, with only 50% of individuals continuing with regular exercise within the first twelve months following the completion of a therapeutic treatment, with a lack of perceived time cited as one of the main barriers. With this in mind, it is important to determine the effects of training dose on the changes in blood pressure seen following IRT. To date there is very little research into the effects of IRT dose on resting blood pressure with only one study purposely investigated the area. Whilst to the authors knowledge no studies have investigated the effects of altered training dose on ambulatory or diurnal blood pressure variations. Although three times a week has become the most commonly applied protocol there is no evidence to confirm that it is the most efficacious. As training dose is an important determinant of adaptations to exercise training, and with a lack of time cited as a perceived barrier to undertaking exercise, there is a need to determine the most efficacious training protocol to elicit clinical reductions in blood pressure, including shorter time saving (once or twice weekly) protocols.
Therefore, the study aims are to determine if a reduction in the weekly dose of isometric training, such as a reduction in the number of total contractions and therefore a reduced time commitment (once or twice weekly) would produce a similar hypotensive response to those reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel
| Arm | Type | Receives |
|---|---|---|
| Once-weekly training | Experimental | Other: Isometric resistance trainingPerformed isometric resistance training once per week (four 2-minute contractions). |
| Twice-weekly training | Experimental | Other: Isometric resistance trainingPerformed isometric resistance training twice per week (eight 2-minute contractions). |
| Thrice-weekly training | Active comparator | Other: Isometric resistance trainingPerformed isometric resistance training thrice per week (12 2-minute contractions). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- not taking anti-hypertensive medication
- borderlerine hypertensive or hypertensive (systolic blood pressure >139 mmHG, diastolic blood pressure > 89 mmHg
Key exclusion criteria (4 listed)
- conditoned to resistance training
- currently taking anti-hypertensive medication
- regularly smoke or vape
- are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric resistance trainingisometric resistance training was performed on the chest, arms, and leg muscle groups using a band. Each contraction, was pulled at a perceived 30% (using a CR10 perceieved exertion rating scale) of maximum effort for 2 minutes; one repetition was performed using each muscle group. Weekly frequnecy changed between groups, ranging from once to thrice per week. | Other | Once-weekly training, Thrice-weekly training, Twice-weekly training |
Primary outcome
Ambulatory blood pressure
Time frame: Through study completion (12 weeks)
Blood pressure assessed during a 24-hour window
1 secondary outcome
Resting blood pressure
Time frame: Through study completion (12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Background: PubMed 30889048Smart NA, Way D, Carlson D, Millar P, McGowan C, Swaine I, Baross A, Howden R, Ritti-Dias R, Wiles J, Cornelissen V, Gordon B, Taylor R, Bleile B. Effects of isometric resistance training on resting blood pressure: individual participant data meta-analysis. J Hypertens. 2019 Oct;37(10):1927-1938. doi: 10.1097/HJH.0000000000002105.
- Background: PubMed 34957769Lopes S, Felix G, Mesquita-Bastos J, Figueiredo D, Oliveira J, Ribeiro F. Determinants of exercise adherence and maintenance among patients with hypertension: a narrative review. Rev Cardiovasc Med. 2021 Dec 22;22(4):1271-1278. doi: 10.31083/j.rcm2204134.
- Background: PubMed 34050340Zhou B, Perel P, Mensah GA, Ezzati M. Global epidemiology, health burden and effective interventions for elevated blood pressure and hypertension. Nat Rev Cardiol. 2021 Nov;18(11):785-802. doi: 10.1038/s41569-021-00559-8. Epub 2021 May 28.
- Background: PubMed 36418149Garcia-Hermoso A, Lopez-Gil JF, Ramirez-Velez R, Alonso-Martinez AM, Izquierdo M, Ezzatvar Y. Adherence to aerobic and muscle-strengthening activities guidelines: a systematic review and meta-analysis of 3.3 million participants across 32 countries. Br J Sports Med. 2023 Feb;57(4):225-229. doi: 10.1136/bjsports-2022-106189. Epub 2022 Nov 23.
- Individual participant dataSharing planned: Yes. Individual participant data will be uplaoded to a reposiotory hosted by The University of Northampton and will be publicly available online. The DOI and URL to the data set will be included in future publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Isometric resistance training in people with Hypertension and Blood Pressure, High, run by The University of Northampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulatory blood pressure (time frame: Through study completion (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07251920, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.