HypertensionNCT02458443
Isometric Handgrip Exercise for Blood Pressure Management
A study testing Isometric resistance training in people with Hypertension, run by University of New England, Australia at 1 site in Australia.
Trial summary
Recent meta-analyses suggest isometric resistance training (IRT) may be superior to aerobic exercise for lowering blood pressure. The investigators intend to conduct the largest, longest, prospective, double-blind randomized controlled trial using isometric resistance training to reduce blood pressure to reduce… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Isometric resistance training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2016to Dec 2016
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Blood pressure above 120/80 currently not taking anti-hypertensive medications whose doctor has suggested would benefit from exercise; and
- people currently taking beta blockers for blood pressure management.
Who cannot join
- Younger than 30yrs and older than 70 yrs;
- unable to voluntary participate;
- unable to participate under doctor's recommendation;
- smokers;
- arthritis or carpal tunnel which may be aggravated with handgrip exercise;
- known cardiovascular disease (angina) and the following co-morbid conditions:
Show all 13Show fewer
- obesity,
- insulin resistance,
- depression,
- mobility impairment,
- sleep apnoea,
- fatty liver disease or
- renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Response to Isometric Resistance Training in People With Hypertension for Blood Pressure Management
Recent meta-analyses suggest isometric resistance training (IRT) may be superior to aerobic exercise for lowering blood pressure. The investigators intend to conduct the largest, longest, prospective, double-blind randomized controlled trial using isometric resistance training to reduce blood pressure to reduce hypertension.
Read the detailed description
We are looking to assess the effect of isometric exercise on ambulatory blood pressure in participants aged 40-70 years who are either pre- or mild hypertensive; either un-medicated or taking medication to control their blood pressure. Our secondary aims are to examine whether the size of blood pressure change is different in those people taking or not taking anti-hypertensive medication, to determine the anti-hypertensive mechanism to IRT, and to establish rate of de-training effects after participants have ceased IRT.
- Conditions
- Hypertension
- Being tested
- Isometric resistance training
- 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 handgrip exercise using a hand dynamometer
| Study group | Role | What they receive |
|---|---|---|
| IHG 5% Un-medicated | Sham comparator | Participants with high blood pressure (greater than 120/80) who are not medicated for blood pressure control will conduct isometric handgrip (IHG) exercise at 5% of their maximum voluntary contraction (MVC). Isometric resistance training will be conducted three times a week for 12 weeks, with participants conducting 4 x 2min IHG exercises at each session. Receives: Other: Isometric resistance training |
| IHG 5% BB | Sham comparator | Participants with high blood pressure (greater than 120/80) who are currently taking beta blockers for blood pressure control will conduct isometric handgrip exercise at 5% of their maximum voluntary contraction (MVC). Isometric resistance training will be conducted three times a week for 12 weeks, with participants conducting 4 x 2min IHG exercises at each session. Receives: Other: Isometric resistance training |
| IHG 30% Un-medicated | Experimental | Participants with high blood pressure (greater than 120/80) who are not medicated for blood pressure control will conduct isometric handgrip exercise at 30% of their maximum voluntary contraction (MVC). Isometric resistance training will be conducted three times a week for 12 weeks, with participants conducting 4 x 2min IHG exercises at each session. Receives: Other: Isometric resistance training |
| IHG 30% BB | Experimental | Participants with high blood pressure (greater than 120/80) who are currently taking beta blockers for blood pressure control will conduct isometric handgrip exercise at 30% of their maximum voluntary contraction (MVC). Isometric resistance training will be conducted three times a week for 12 weeks, with participants conducting 4 x 2min IHG exercises at each session. Receives: Other: Isometric resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic and diastolic blood pressure
Measured: Change measures: baseline and 12 weeks
Secondary outcomes (2)
Compare and contrast change in systolic and diastolic blood pressure of medicated and un-medicated participants
Measured: Baseline and 12 weeks
Detraining effects, changes in systolic and diastolic blood pressure after cessation of Isometric Resistance Training
End of exercise protocol and 12 weeks after completion
Measured: 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New England, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deb Carlson, University of New England, Australia
- Investigators
- Neil Smart, PhD, Principal investigator, University of New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458443
- Sponsor's protocol ID
- UNewEngland
- Status last verified
- Dec 2020
- First submitted
- 21 May 2015
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Carlson DJ, Dieberg G, Hess NC, Millar PJ, Smart NA. Isometric exercise training for blood pressure management: a systematic review and meta-analysis. Mayo Clin Proc. 2014 Mar;89(3):327-34. doi: 10.1016/j.mayocp.2013.10.030.
PubMed 24582191
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Response to Isometric Resistance Training in People With Hypertension for Blood Pressure Management
- ClinicalTrials.gov ID
- NCT02458443
- Acronym / sponsor ID
- UNewEngland
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of New England, AustraliaUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 1 Jun 2015 (estimated)
- 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.
Recent meta-analyses suggest isometric resistance training (IRT) may be superior to aerobic exercise for lowering blood pressure. The investigators intend to conduct the largest, longest, prospective, double-blind randomized controlled trial using isometric resistance training to reduce blood pressure to reduce hypertension.
Detailed description
We are looking to assess the effect of isometric exercise on ambulatory blood pressure in participants aged 40-70 years who are either pre- or mild hypertensive; either un-medicated or taking medication to control their blood pressure. Our secondary aims are to examine whether the size of blood pressure change is different in those people taking or not taking anti-hypertensive medication, to determine the anti-hypertensive mechanism to IRT, and to establish rate of de-training effects after participants have ceased IRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IHG 5% Un-medicated | Sham comparator | Other: Isometric resistance trainingParticipants with high blood pressure (greater than 120/80) who are not medicated for blood pressure control will conduct isometric handgrip (IHG) exercise at 5% of their maximum voluntary contraction (MVC). Isometric resistance training will be conducted three times a week for 12 weeks, with participants conducting 4 x 2min IHG exercises at each session. |
| IHG 5% BB | Sham comparator | Other: Isometric resistance trainingParticipants with high blood pressure (greater than 120/80) who are currently taking beta blockers for blood pressure control will conduct isometric handgrip exercise at 5% of their maximum voluntary contraction (MVC). Isometric resistance training will be conducted three times a week for 12 weeks, with participants conducting 4 x 2min IHG exercises at each session. |
| IHG 30% Un-medicated | Experimental | Other: Isometric resistance trainingParticipants with high blood pressure (greater than 120/80) who are not medicated for blood pressure control will conduct isometric handgrip exercise at 30% of their maximum voluntary contraction (MVC). Isometric resistance training will be conducted three times a week for 12 weeks, with participants conducting 4 x 2min IHG exercises at each session. |
| IHG 30% BB | Experimental | Other: Isometric resistance trainingParticipants with high blood pressure (greater than 120/80) who are currently taking beta blockers for blood pressure control will conduct isometric handgrip exercise at 30% of their maximum voluntary contraction (MVC). Isometric resistance training will be conducted three times a week for 12 weeks, with participants conducting 4 x 2min IHG exercises at each session. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Blood pressure above 120/80 currently not taking anti-hypertensive medications whose doctor has suggested would benefit from exercise; and
- people currently taking beta blockers for blood pressure management.
Key exclusion criteria (13 listed)
- Younger than 30yrs and older than 70 yrs;
- unable to voluntary participate;
- unable to participate under doctor's recommendation;
- smokers;
- arthritis or carpal tunnel which may be aggravated with handgrip exercise;
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 handgrip exercise using a hand dynamometer | Other | IHG 30% BB, IHG 30% Un-medicated, IHG 5% BB, IHG 5% Un-medicated |
Primary outcome
Change in systolic and diastolic blood pressure
Time frame: Change measures: baseline and 12 weeks
2 secondary outcomes
Compare and contrast change in systolic and diastolic blood pressure of medicated and un-medicated participants
Time frame: Baseline and 12 weeks
Detraining effects, changes in systolic and diastolic blood pressure after cessation of Isometric Resistance Training
Time frame: 12 weeks and 24 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 17 Dec 2020.
- Background: PubMed 24582191Carlson DJ, Dieberg G, Hess NC, Millar PJ, Smart NA. Isometric exercise training for blood pressure management: a systematic review and meta-analysis. Mayo Clin Proc. 2014 Mar;89(3):327-34. doi: 10.1016/j.mayocp.2013.10.030.
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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.
Neil Smart, PhD principal investigator
University of New England
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric resistance training in people with Hypertension, run by University of New England, Australia at 1 site in Australia.
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 13 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 17 Dec 2020. 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 Australia. 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. Some participants in this study may receive a placebo. 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?
Change in systolic and diastolic blood pressure (time frame: Change measures: baseline and 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 NCT02458443, which also lists 1 linked publication.
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 17 Dec 2020; AzTrials last refreshed its copy on 30 Oct 2026.