HypertensionNCT06335433
Isometric Handgrip Training Frequency and Blood Pressure in People With Hypertension
A study testing Exercise Training (Isometric Handgrip Exercise) in people with Hypertension, run by Swansea University at 1 site in United Kingdom.
Trial summary
Hypertension is the most important cause of cardiovascular disease (CVD), stroke, and premature death (WHO, 2021). It is estimated by The World Health Organisation in 2021 that 1.4 billion individuals across the globe have high blood pressure, with only 14% of people actively managing these elevated levels. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Exercise Training (Isometric Handgrip Exercise)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Mar 2024to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years.
- Scoring low or moderate on the international physical activity questionnaire (IPAQ).
- Previous diagnosis of high blood pressure and/or a resting systolic blood pressure ≥130 but <180 mmHg (self-reported and confirmed during screening/baseline assessment).
- Currently taking no anti-hypertensive medicine or taking anti-hypertensive medicine with no treatment change within the last 4 months prior to enrollment.
- Stable dietary and physical activity patterns (including dietary supplementation) over the last 4 months
Who cannot join
- Aged <18 or >65 years
- Resting blood pressure ≥180/110 mmHg or resting heart rate >100 bpm during baseline as-sessment
- Manifest cardiovascular disease including cerebrovascular disease, heart failure, chronic kidney disease, peripheral vascular disease, or advanced retinopathy (fundus hypertonicus grades III-IV) based on a self-report health history questionnaire.
- Type 1 diabetes
- History of other chronic disease including malignancy, neurological conditions (e.g. multiple sclerosis) or respiratory conditions (e.g. COPD).
- Contraindications to exercise based on answers to the physical activity readiness questionnaire.
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- Physical limitations preventing handgrip exercise (e.g. arthritis or other musculoskeletal disorder)
- Scoring "high" on the international physical activity questionnaire
- Taking more than 2 anti-hypertensive drugs or a change in treatment strategy in the previous 4 months.
- Currently taking nitrate medication (as it is commonly prescribed for angina) or on hormone replacement therapy
- Significant self-reported change in lifestyle patterns in the prior 4 months (e.g. currently on a planned diet for weight loss).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Swansea University
Swansea, Wales, SA18EN
Richard Metcalfe, PhD, 01792205678 ext. 4779, r.s.metcalfe@swansea.ac.uk
About this study
Official title: The Dose Response Effect of Isometric Handgrip Training Frequency on Blood Pressure and Vascular Health in People With Hypertension: A Randomised Controlled Trial
Hypertension is the most important cause of cardiovascular disease (CVD), stroke, and premature death (WHO, 2021). It is estimated by The World Health Organisation in 2021 that 1.4 billion individuals across the globe have high blood pressure, with only 14% of people actively managing these elevated levels. Simple and effective lifestyle strategies are required to help people improve their blood pressure and/or attenuate increases in blood pressure with ageing. Physical activity is one possible strategy: in previous research, several different types of physical activity have been shown to have beneficial effects on blood pressure (Blackwell et al., 2017). However, many individuals do not adhere to currently recommended levels of physical activity (150 mins of moderate intensity physical activity per week), due to a combination of the required time commitment, lack of motivation, and the associated levels of effort, exertion, and physical discomfort (Korkiakangas et al 2009). Thus, there is a need to identify alternative exercise interventions which will overcome these barriers but remain effective at improving blood pressure (Herrod, Lund, \& Phillips, 2021, Toohey et al, 2018).
Low intensity isometric hand grip exercise training (IET) has been shown to result in large decreases in resting blood pressure in younger and older age groups, in both men and women, and in individuals with normal as well as elevated baseline blood pressure (Badrov et al, 2013; Bentley et al., 2018; Millar et al., 2014). In this research, IET has almost universally involved performing 4 x 2 IET holds at 30% of maximal voluntary contraction, 3 times a week, over a 4-8-week intervention (Millar et al, 2014). There are very few studies that have investigated the effect of changing different protocol parameters on changes in blood pressure and vascular health, and the minimal effective dose of IET is unknown. Defining the minimal effective dose of different types of exercise may help overcome key barriers to exercise by lowering the required time commitment, reducing perceived effort/exertion, and promoting more positive affective responses. One important modifiable parameter is training frequency and it is unknown whether reducing the frequency of IET will reduce the efficacy for improving blood pressure.
Therefore, the primary objective of this study is to determine if reducing the frequency of isometric handgrip training from four times a week to two times a week will affect the improvements in resting blood pressure and vascular health in people with hypertension. A secondary objective is to investigate the acute affective and perceptual responses to sessions of IET and the effect of training on these acute affective/perceptual responses.
- Conditions
- Hypertension
- Being tested
- Exercise Training (Isometric Handgrip Exercise)
- Keywords
- High Blood Pressure, Isometric Handgrip Exercise, Vascular Health, Training Frequency, Dose Response, Perceptual Responses
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Training (Isometric Handgrip Exercise)Other
Participants allocated to the exercise groups will complete 6 weeks of isometric handgrip exercise training (IHGT) using an electronic hand dynamometer (Camry EH101, Zhongshan Camry Electronic Co. Ltd, Guangdong) for either 2 or 4 sessions per week. Each exercise session will consist of 4 x 2-minute isometric contractions at 30% MVC with 1 minute rest periods between contractions. The first bout will be performed on the dominant arm and then the arm will be alternated for each subsequent two-minute bout. Participants will be instructed to try keep the contraction tension as close as possible to the set tension of 30% MVC using visual feedback from the dynamometer's electronic display.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention Control | No intervention | Participants will be asked to maintain their normal lifestyle patterns (i.e. diet and physical activity) and will undergo no other intervention. |
| Two Sessions/Week | Experimental | Participants will complete 6-weeks of supervised isometric handgrip exercise training with a frequency of two sessions/week Receives: Other: Exercise Training (Isometric Handgrip Exercise) |
| Four Sessions/Week | Experimental | Participants will complete 6-weeks of supervised isometric handgrip exercise training with a frequency of four sessions/week Receives: Other: Exercise Training (Isometric Handgrip Exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Office measured supine and seated systolic, diastolic and mean arterial pressure
Office measured supine and seated systolic, diastolic and mean arterial pressure will be measured at baseline and 3 days following the final exercise session
Measured: 6 weeks
Secondary outcomes (7)
Office measured central systolic, diastolic and mean arterial pressure
Office measured central systolic, diastolic and mean arterial pressure will be measured at baseline and 3 days following the final exercise session
Measured: 6 weeks
24-h mean ambulatory systolic, diastolic, and mean arterial pressure
24-h mean ambulatory systolic, diastolic, and mean arterial pressure will be measured at baseline and 3 days following the final exercise session
Measured: 6 weeks
Daytime ambulatory systolic, diastolic, and mean arterial pressure
Daytime ambulatory systolic, diastolic, and mean arterial pressure will be measured at baseline and then 3 days following the final exercise session
Measured: 6 weeks
Sleeping ambulatory systolic, diastolic and mean arterial pressure
Sleeping ambulatory systolic, diastolic and mean arterial pressure will be measured at baseline and then 3 days after the final exercise session
Measured: 6 weeks
Carotid-Femoral Pulse Wave Velocity
Carotid-Femoral Pulse Wave Velocity will be measured at baseline and then 3 days after the final exercise session
Measured: 6 weeks
Affective Valence (Feeling Scale)
Affective valence will be measured at regular intervals during the isometric handgrip exercise sessions. Ratings will be collected during the first session and then during the final session of each training week.
Measured: 6 weeks
Ratings of perceived exertion
Ratings of perceived exertion will be measured at regular intervals during the isometric handgrip exercise sessions. Ratings will be collected during the first session and then during the final session of each training week.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start20 Mar 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Metcalfe, PhD, Principal investigator, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335433
- Sponsor's protocol ID
- RM_30_06_22b
- Status last verified
- Jul 2026
- First submitted
- 21 Mar 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dose Response Effect of Isometric Handgrip Training Frequency on Blood Pressure and Vascular Health in People With Hypertension: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06335433
- Acronym / sponsor ID
- RM_30_06_22b
- Conditions
- Hypertension
- Keywords
- High Blood Pressure, Isometric Handgrip Exercise, Vascular Health, Training Frequency, Dose Response, Perceptual Responses
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 28 Mar 2024 (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.
Hypertension is the most important cause of cardiovascular disease (CVD), stroke, and premature death (WHO, 2021). It is estimated by The World Health Organisation in 2021 that 1.4 billion individuals across the globe have high blood pressure, with only 14% of people actively managing these elevated levels. Simple and effective lifestyle strategies are required to help people improve their blood pressure and/or attenuate increases in blood pressure with ageing. Physical activity is one possible strategy: in previous research, several different types of physical activity have been shown to have beneficial effects on blood pressure (Blackwell et al., 2017). However, many individuals do not adhere to currently recommended levels of physical activity (150 mins of moderate intensity physical activity per week), due to a combination of the required time commitment, lack of motivation, and the associated levels of effort, exertion, and physical discomfort (Korkiakangas et al 2009). Thus, there is a need to identify alternative exercise interventions which will overcome these barriers but remain effective at improving blood pressure (Herrod, Lund, \& Phillips, 2021, Toohey et al, 2018).
Low intensity isometric hand grip exercise training (IET) has been shown to result in large decreases in resting blood pressure in younger and older age groups, in both men and women, and in individuals with normal as well as elevated baseline blood pressure (Badrov et al, 2013; Bentley et al., 2018; Millar et al., 2014). In this research, IET has almost universally involved performing 4 x 2 IET holds at 30% of maximal voluntary contraction, 3 times a week, over a 4-8-week intervention (Millar et al, 2014). There are very few studies that have investigated the effect of changing different protocol parameters on changes in blood pressure and vascular health, and the minimal effective dose of IET is unknown. Defining the minimal effective dose of different types of exercise may help overcome key barriers to exercise by lowering the required time commitment, reducing perceived effort/exertion, and promoting more positive affective responses. One important modifiable parameter is training frequency and it is unknown whether reducing the frequency of IET will reduce the efficacy for improving blood pressure.
Therefore, the primary objective of this study is to determine if reducing the frequency of isometric handgrip training from four times a week to two times a week will affect the improvements in resting blood pressure and vascular health in people with hypertension. A secondary objective is to investigate the acute affective and perceptual responses to sessions of IET and the effect of training on these acute affective/perceptual responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| No Intervention Control | No intervention | –Participants will be asked to maintain their normal lifestyle patterns (i.e. diet and physical activity) and will undergo no other intervention. |
| Two Sessions/Week | Experimental | Other: Exercise Training (Isometric Handgrip Exercise)Participants will complete 6-weeks of supervised isometric handgrip exercise training with a frequency of two sessions/week |
| Four Sessions/Week | Experimental | Other: Exercise Training (Isometric Handgrip Exercise)Participants will complete 6-weeks of supervised isometric handgrip exercise training with a frequency of four sessions/week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 18 and 65 years.
- Scoring low or moderate on the international physical activity questionnaire (IPAQ).
- Previous diagnosis of high blood pressure and/or a resting systolic blood pressure ≥130 but <180 mmHg (self-reported and confirmed during screening/baseline assessment).
- Currently taking no anti-hypertensive medicine or taking anti-hypertensive medicine with no treatment change within the last 4 months prior to enrollment.
- Stable dietary and physical activity patterns (including dietary supplementation) over the last 4 months
Key exclusion criteria (11 listed)
- Aged <18 or >65 years
- Resting blood pressure ≥180/110 mmHg or resting heart rate >100 bpm during baseline as-sessment
- Manifest cardiovascular disease including cerebrovascular disease, heart failure, chronic kidney disease, peripheral vascular disease, or advanced retinopathy (fundus hypertonicus grades III-IV) based on a self-report health history questionnaire.
- Type 1 diabetes
- History of other chronic disease including malignancy, neurological conditions (e.g. multiple sclerosis) or respiratory conditions (e.g. COPD).
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 |
|---|---|---|
| Exercise Training (Isometric Handgrip Exercise)Participants allocated to the exercise groups will complete 6 weeks of isometric handgrip exercise training (IHGT) using an electronic hand dynamometer (Camry EH101, Zhongshan Camry Electronic Co. Ltd, Guangdong) for either 2 or 4 sessions per week. Each exercise session will consist of 4 x 2-minute isometric contractions at 30% MVC with 1 minute rest periods between contractions. The first bout will be performed on the dominant arm and then the arm will be alternated for each subsequent two-minute bout. Participants will be instructed to try keep the contraction tension as close as possible to the set tension of 30% MVC using visual feedback from the dynamometer's electronic display. | Other | Four Sessions/Week, Two Sessions/Week |
Primary outcome
Office measured supine and seated systolic, diastolic and mean arterial pressure
Time frame: 6 weeks
Office measured supine and seated systolic, diastolic and mean arterial pressure will be measured at baseline and 3 days following the final exercise session
7 secondary outcomes
Office measured central systolic, diastolic and mean arterial pressure
Time frame: 6 weeks
24-h mean ambulatory systolic, diastolic, and mean arterial pressure
Time frame: 6 weeks
Daytime ambulatory systolic, diastolic, and mean arterial pressure
Time frame: 6 weeks
Sleeping ambulatory systolic, diastolic and mean arterial pressure
Time frame: 6 weeks
Carotid-Femoral Pulse Wave Velocity
Time frame: 6 weeks
Affective Valence (Feeling Scale)
Time frame: 6 weeks
Ratings of perceived exertion
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Richard Metcalfe, PhD principal investigator
Swansea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training (Isometric Handgrip Exercise) in people with Hypertension, run by Swansea University 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard Metcalfe, PhD (01792205678 ext. 4779, r.s.metcalfe@swansea.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Office measured supine and seated systolic, diastolic and mean arterial pressure (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2026.