Blood PressureNCT06329804
The Dose Response Effect of Isometric Handgrip Training Frequency on Blood Pressure in Normotensive Individuals
A study testing Isometric Handgrip Exercise Training (IHGT) in people with Blood Pressure, run by Swansea University at 2 sites in 2 countries.
Trial summary
It is estimated by WHO (2021) that 1.4 billion individuals across the globe have high blood pressure with only 14% of people 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Isometric Handgrip Exercise Training (IHGT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Nov 2021to 31 May 2024
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 40 years
- Scoring 'low' on the international physical activity questionnaire (IPAQ)
- Apparently healthy with no indications of chronic disease according to a self-report health history questionnaire and the physical activity readiness questionnaire.
- Resting blood pressure <140/90 mmHg during baseline assessment.
Who cannot join
- Aged <18 or >40 years
- Previously diagnosed with hypertension and/or currently taking anti-hypertensive medication.
- Any contraindication to exercise based on responses to the self-report health-history questionnaire or the physical activity readiness questionnaire.
- Scoring moderate or high on the international physical activity questionnaire (IPAQ).
- Resting blood pressure >140/90 mmHg during baseline assessment.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: The Dose Response Effect of Isometric Handgrip Training Frequency on Blood Pressure: a Randomised Controlled Trial in Normotensive Individuals
It is estimated by WHO (2021) that 1.4 billion individuals across the globe have high blood pressure with only 14% of people 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. Exercise is one possible strategy: in previous research, several different types of exercise have been shown to have effects on blood pressure (Blackwell et al., 2017). However, many individuals do not adhere to currently recommended levels of exercise (150 mins of moderate intensity exercise per week), due to a combination of the required time commitment, lack of motivation, and the associated levels of effort / exertion and discomfort (Korkiakangas et al 2009). Thus, there is a need to investigate alternative exercise interventions which will overcome these barriers but remain effective at improving blood pressure (Herrod, Lund, \& Phillips, 2021).
Low intensity isometric hand grip training (IHGT) has been shown to result in large decreases in rest-ing 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, IHGT has typically involved performing 4 x 2 IHGT holds at 30% of maximal voluntary contraction, 3 times a week, over a 4-8-week intervention (Millar et al, 2014). Interestingly, there are very few studies that have investigated the effect of changing different protocol parameters on the adaptations in blood pressure, and the minimal effective dose of IHGT is unknown. One important modifiable parameter is training frequency and it is unknown whether reducing the frequency of IHGT will reduce the efficacy for improving blood pressure. Therefore, the aim of this randomised controlled trial is to compare the effect of IHGT with a frequency of 2 or 4 sessions/week on resting blood pressure.
Read the detailed description
Data collection for this study will take place at two University sites: Swansea University in The UK and National Taiwan Normal University in Taiwan. Separate ethical approval will be sought at each site.
Participants
The primary outcome in this study will be the change in clinic measured systolic blood pressure. In a meta-analysis of 147 RCTs, a 10 mmHg decrease in SBP reduced CHD events by 22% (Law 2009). We powered this study to be able to detect a smallest worthwhile effect of 3.0 mmHg (equivalent to a CHD risk reduction of ~7%). Based on the standard deviation of repeated measures of systolic blood pressure of ~2.9 mmHg in our laboratory, a sample size of 45 participants (15 per group) will achieve 80% power to detect this difference with an alpha of 0.05. Therefore, in order to ensure equal recruitment across both study sites, we will recruit up 30 participants (10 per group) at each site. Participants will be low active men and women who do not currently meet the recommended physical activity guidelines (age range: 18-40 years).
The study protocol will be fully explained to all subjects in written and verbal form before they are asked to provide written consent. Participants will be randomised to one of three experimental groups, performing either 2 or 4 isometric handgrip training sessions per week for 4 weeks, or a no-intervention control.
Baseline Testing
Participants will be asked to attend the sport and exercise science laboratory at Swansea University Bay Campus for a baseline assessment of blood pressure. Participants will be asked to refrain from any strenuous exercise for 2 days prior and from consuming any alcohol for 1 day prior to testing. Caffeine intake will be permitted in the day prior to testing but we will ask participants to complete a 1-day food diary (including caffeine containing products) prior to the baseline testing and we will ask participants to replicate this diet prior to the post-training assessment. Participants will attend the lab in the morning between 8 and 10am after fasting (water only) from 10pm the previous even-ing. To ensure they are hydrated they will be asked to consume 1 pint of water immediately upon waking.
Participants' blood pressure will be measured following a 10-minute rest period in a supine position in a dark room. Blood pressure will then be measured in the (unclothed) left arm using an automat-ed monitor (Omron MIT elite plus) whilst participants remain in the supine position. Blood pressure will be measured three times with 1 minute rest intervals in between. If there is a less than 5 mmHg difference between the final two readings, then the mean of these two readings will be taken forward for analysis (Pickering et al, 2005). If there is a difference >5 mmHg between the two readings, then 2 additional readings will be taken and the mean of the 4 readings will be taken for-ward for analysis (Pickering et al, 2005). Arm circumference will be measured prior to the blood pressure measurement to determine the correct cuff size.
Following blood pressure assessment, participants will be randomised to their experimental group using the envelope method. Participants who are randomised to the IHGT group will be asked to perform a 1 repetition maximum for an isometric handgrip contraction, to determine IHGT intensity. The best of 3 measurements of the dominant arm will be used to determine training intensity.
IHGT intervention
Participants allocated to the IHGT groups will complete a 4-week home-based IHGT intervention involving either 2 or 4 sessions per week. Each session will consist of 4 x 2-minute contractions at 30% maximal voluntary contraction, with 2-minutes of rest in between, performed with the dominant hand. Training will be performed using an electronic hand dynamometer (Camry EH101, Zhongshan Camry Electronic Co. Ltd, Guangdong).
Training sessions will be scheduled on weekdays and all sessions will be supervised by 1 member of the research team via Zoom to ensure compliance and training fidelity. During every session, the researcher will record the contraction tension every 15 seconds during each 2-minute contraction. In addition, during the first session of each training week, a rating of perceived exertion (Borg scale) and affective valence (feeling scale) will be measured every 30 seconds, during each 2-minute contraction.
Post-Training Testing
Resting blood pressure and grip strength will be measured three days following the final training session using identical procedures to the pre-training assessment (described above).
- Conditions
- Blood Pressure
- Being tested
- Isometric Handgrip Exercise Training (IHGT)
- Keywords
- Blood Pressure, Isometric Handgrip Exercise, Dose Response, Training Frequency, Perceptual Responses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric Handgrip Exercise Training (IHGT)Other
Each IHGT session will consist of 4 x 2-minute contractions at 30% maximal voluntary contraction, with 2-minutes of rest in between, performed with the dominant hand. Training will be performed using an electronic hand dynamometer (Camry EH101, Zhongshan Camry Electronic Co. Ltd, Guangdong).
| Study group | Role | What they receive |
|---|---|---|
| No Intervention Control | No intervention | Participants allocated to this group will maintain their usual lifestyle for 4-weeks |
| Two Sessions/Week | Experimental | Participants allocated to this group will complete 4-weeks of isometric handgrip exercise training with a frequency of two sessions/week Receives: Other: Isometric Handgrip Exercise Training (IHGT) |
| Four Sessions/Week | Active comparator | Participants allocated to this group will complete 4-weeks of isometric handgrip exercise training with a frequency of four sessions/week Receives: Other: Isometric Handgrip Exercise Training (IHGT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Systolic Blood Pressure
Resting systolic blood pressure will be measured before training commences and then 3 days after the final exercise session.
Measured: 4 weeks
Secondary outcomes (2)
Resting Diastolic Blood Pressure
Resting diastolic blood pressure will be measured before training commences and then 3 days after the final exercise session.
Measured: 4 weeks
Resting Mean Arterial Blood Pressure
Resting mean arterial blood pressure will be measured before training commences and then 3 days after the final exercise session.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Nov 2021
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan Normal University
- Responsible party
- Sponsor
- Investigators
- Richard Metcalfe, PhD, Principal investigator, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329804
- Sponsor's protocol ID
- RM_01-11-21b
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 3 Dec 2024
- 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 3 Dec 2024. 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: a Randomised Controlled Trial in Normotensive Individuals
- ClinicalTrials.gov ID
- NCT06329804
- Acronym / sponsor ID
- RM_01-11-21b
- Conditions
- Blood Pressure
- Keywords
- Blood Pressure, Isometric Handgrip Exercise, Dose Response, Training Frequency, Perceptual Responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Collaborators
- National Taiwan Normal University
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 26 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.
It is estimated by WHO (2021) that 1.4 billion individuals across the globe have high blood pressure with only 14% of people 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. Exercise is one possible strategy: in previous research, several different types of exercise have been shown to have effects on blood pressure (Blackwell et al., 2017). However, many individuals do not adhere to currently recommended levels of exercise (150 mins of moderate intensity exercise per week), due to a combination of the required time commitment, lack of motivation, and the associated levels of effort / exertion and discomfort (Korkiakangas et al 2009). Thus, there is a need to investigate alternative exercise interventions which will overcome these barriers but remain effective at improving blood pressure (Herrod, Lund, \& Phillips, 2021).
Low intensity isometric hand grip training (IHGT) has been shown to result in large decreases in rest-ing 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, IHGT has typically involved performing 4 x 2 IHGT holds at 30% of maximal voluntary contraction, 3 times a week, over a 4-8-week intervention (Millar et al, 2014). Interestingly, there are very few studies that have investigated the effect of changing different protocol parameters on the adaptations in blood pressure, and the minimal effective dose of IHGT is unknown. One important modifiable parameter is training frequency and it is unknown whether reducing the frequency of IHGT will reduce the efficacy for improving blood pressure. Therefore, the aim of this randomised controlled trial is to compare the effect of IHGT with a frequency of 2 or 4 sessions/week on resting blood pressure.
Detailed description
Data collection for this study will take place at two University sites: Swansea University in The UK and National Taiwan Normal University in Taiwan. Separate ethical approval will be sought at each site.
Participants
The primary outcome in this study will be the change in clinic measured systolic blood pressure. In a meta-analysis of 147 RCTs, a 10 mmHg decrease in SBP reduced CHD events by 22% (Law 2009). We powered this study to be able to detect a smallest worthwhile effect of 3.0 mmHg (equivalent to a CHD risk reduction of ~7%). Based on the standard deviation of repeated measures of systolic blood pressure of ~2.9 mmHg in our laboratory, a sample size of 45 participants (15 per group) will achieve 80% power to detect this difference with an alpha of 0.05. Therefore, in order to ensure equal recruitment across both study sites, we will recruit up 30 participants (10 per group) at each site. Participants will be low active men and women who do not currently meet the recommended physical activity guidelines (age range: 18-40 years).
The study protocol will be fully explained to all subjects in written and verbal form before they are asked to provide written consent. Participants will be randomised to one of three experimental groups, performing either 2 or 4 isometric handgrip training sessions per week for 4 weeks, or a no-intervention control.
Baseline Testing
Participants will be asked to attend the sport and exercise science laboratory at Swansea University Bay Campus for a baseline assessment of blood pressure. Participants will be asked to refrain from any strenuous exercise for 2 days prior and from consuming any alcohol for 1 day prior to testing. Caffeine intake will be permitted in the day prior to testing but we will ask participants to complete a 1-day food diary (including caffeine containing products) prior to the baseline testing and we will ask participants to replicate this diet prior to the post-training assessment. Participants will attend the lab in the morning between 8 and 10am after fasting (water only) from 10pm the previous even-ing. To ensure they are hydrated they will be asked to consume 1 pint of water immediately upon waking.
Participants' blood pressure will be measured following a 10-minute rest period in a supine position in a dark room. Blood pressure will then be measured in the (unclothed) left arm using an automat-ed monitor (Omron MIT elite plus) whilst participants remain in the supine position. Blood pressure will be measured three times with 1 minute rest intervals in between. If there is a less than 5 mmHg difference between the final two readings, then the mean of these two readings will be taken forward for analysis (Pickering et al, 2005). If there is a difference >5 mmHg between the two readings, then 2 additional readings will be taken and the mean of the 4 readings will be taken for-ward for analysis (Pickering et al, 2005). Arm circumference will be measured prior to the blood pressure measurement to determine the correct cuff size.
Following blood pressure assessment, participants will be randomised to their experimental group using the envelope method. Participants who are randomised to the IHGT group will be asked to perform a 1 repetition maximum for an isometric handgrip contraction, to determine IHGT intensity. The best of 3 measurements of the dominant arm will be used to determine training intensity.
IHGT intervention
Participants allocated to the IHGT groups will complete a 4-week home-based IHGT intervention involving either 2 or 4 sessions per week. Each session will consist of 4 x 2-minute contractions at 30% maximal voluntary contraction, with 2-minutes of rest in between, performed with the dominant hand. Training will be performed using an electronic hand dynamometer (Camry EH101, Zhongshan Camry Electronic Co. Ltd, Guangdong).
Training sessions will be scheduled on weekdays and all sessions will be supervised by 1 member of the research team via Zoom to ensure compliance and training fidelity. During every session, the researcher will record the contraction tension every 15 seconds during each 2-minute contraction. In addition, during the first session of each training week, a rating of perceived exertion (Borg scale) and affective valence (feeling scale) will be measured every 30 seconds, during each 2-minute contraction.
Post-Training Testing
Resting blood pressure and grip strength will be measured three days following the final training session using identical procedures to the pre-training assessment (described above).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Intervention Control | No intervention | –Participants allocated to this group will maintain their usual lifestyle for 4-weeks |
| Two Sessions/Week | Experimental | Other: Isometric Handgrip Exercise Training (IHGT)Participants allocated to this group will complete 4-weeks of isometric handgrip exercise training with a frequency of two sessions/week |
| Four Sessions/Week | Active comparator | Other: Isometric Handgrip Exercise Training (IHGT)Participants allocated to this group will complete 4-weeks of isometric handgrip exercise training with a frequency of four sessions/week |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged between 18 and 40 years
- Scoring 'low' on the international physical activity questionnaire (IPAQ)
- Apparently healthy with no indications of chronic disease according to a self-report health history questionnaire and the physical activity readiness questionnaire.
- Resting blood pressure <140/90 mmHg during baseline assessment.
Key exclusion criteria (5 listed)
- Aged <18 or >40 years
- Previously diagnosed with hypertension and/or currently taking anti-hypertensive medication.
- Any contraindication to exercise based on responses to the self-report health-history questionnaire or the physical activity readiness questionnaire.
- Scoring moderate or high on the international physical activity questionnaire (IPAQ).
- Resting blood pressure >140/90 mmHg during baseline assessment.
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 Handgrip Exercise Training (IHGT)Each IHGT session will consist of 4 x 2-minute contractions at 30% maximal voluntary contraction, with 2-minutes of rest in between, performed with the dominant hand. Training will be performed using an electronic hand dynamometer (Camry EH101, Zhongshan Camry Electronic Co. Ltd, Guangdong). | Other | Four Sessions/Week, Two Sessions/Week |
Primary outcome
Resting Systolic Blood Pressure
Time frame: 4 weeks
Resting systolic blood pressure will be measured before training commences and then 3 days after the final exercise session.
2 secondary outcomes
Resting Diastolic Blood Pressure
Time frame: 4 weeks
Resting Mean Arterial Blood Pressure
Time frame: 4 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 3 Dec 2024.
- 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. This study is not recruiting at the moment.
Richard Metcalfe, PhD principal investigator
Swansea University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric Handgrip Exercise Training (IHGT) in people with Blood Pressure, run by Swansea University at 2 sites in 2 countries.
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 4 inclusion and 5 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 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan, 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?
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?
Resting Systolic Blood Pressure (time frame: 4 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 3 Dec 2024.