HypertensionNCT02458456
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
The aim of this project is to conduct a randomised controlled trial to assess the effect of performing isometric exercise using a handgrip dynamometer on blood pressure. 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
- 120 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2014to 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
- Those within the required age limits, both normotensive, pre-hypertensive, and those medicated for blood pressure management.
Who cannot join
- Younger than 30 years and older than 70 years; those deemed not to have the capacity to voluntarily participate, unable to participate under their doctor's recommendation, or with arthritis or carpal tunnel syndrome who may aggravate their condition with handgrip exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Isometric Handgrip Exercise for Blood Pressure Management. A Randomized, Controlled Trial
The aim of this project is to conduct a randomised controlled trial to assess the effect of performing isometric exercise using a handgrip dynamometer on blood pressure.
Read the detailed description
Recent meta-analyses suggest isometric resistance training (IRT) may be superior to aerobic exercise for lowering blood pressure. A randomised controlled study will be conducted with participants who are either pre-hypertensive, blood pressure between 120/80 and 140/90, or on medication to control their blood pressure. Previous studies have utilised a sedentary control so we intend to use a sham group to determine if it can be used as a working control for future studies.
- 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 exercise using a hand dynamometer.
| Study group | Role | What they receive |
|---|---|---|
| IHG 5% Hypertensive | Sham comparator | Participants who are either un-medicated pre-hypertensive or medicated for blood pressure management conducting isometric resistance training using a hand dynamometer at 5% of their maximum voluntary contraction. Participants with perform 4 x 2 minutes isometric handgrip exercises 3 times per week under supervision for 8 weeks. Receives: Other: Isometric resistance training |
| IHG 30% Hypertensive | Experimental | Participants who are either un-medicated pre-hypertensive or medicated for blood pressure management conducting isometric resistance training using a hand dynamometer at 30% of their maximum voluntary contraction. Participants with perform 4 x 2 minutes isometric handgrip exercises 3 times per week under supervision for 8 weeks. Receives: Other: Isometric resistance training |
| IHG 30% Normotensive | Experimental | Participants who are normotensive conducting isometric resistance training using a hand dynamometer at 30% of their maximum voluntary contraction. Participants with perform 4 x 2 minutes isometric handgrip exercises 3 times per week under supervision for 8 weeks. Receives: Other: Isometric resistance training |
| IHG 5% Normotensive | Sham comparator | Participants who are normotensive conducting isometric resistance training using a hand dynamometer at 5% of their maximum voluntary contraction. Participants with perform 4 x 2 minutes isometric handgrip exercises 3 times per week under supervision for 8 weeks. Receives: Other: Isometric resistance training |
| IHG 10% Hypertensive | Experimental | Participants who are either un-medicated pre-hypertensive or medicated for blood pressure management conducting isometric resistance training using a hand dynamometer at 10% of their maximum voluntary contraction. Participants with perform 4 x 2 minutes isometric handgrip exercises 3 times per week under supervision for 8 weeks. Receives: Other: Isometric resistance training |
| IHG 10% Normotensive | Experimental | Participants who are normotensive conducting isometric resistance training using a hand dynamometer at 10% of their maximum voluntary contraction. Participants with perform 4 x 2 minutes isometric handgrip exercises 3 times per week under supervision for 8 weeks. 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: Baseline and 8 weeks
Secondary outcomes (2)
Compare and contrast changes in blood pressure between the 5% maximum voluntary contraction (MVC) and 30% MVC hypertensive groups
Measured: Baseline and 8 weeks
Compare and contrast blood pressure changes between the 30% maximum voluntary contraction (MVC) hypertensive and 30% MVC normotensive groups
Measured: Baseline and 8 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 startAug 2014
- Primary completionNov 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 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
- Investigators
- Neil Smart, PhD, Principal investigator, University of New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458456
- Sponsor's protocol ID
- UNewEngland1
- 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
- Isometric Handgrip Exercise for Blood Pressure Management. A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02458456
- Acronym / sponsor ID
- UNewEngland1
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of New England, AustraliaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Nov 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.
The aim of this project is to conduct a randomised controlled trial to assess the effect of performing isometric exercise using a handgrip dynamometer on blood pressure.
Detailed description
Recent meta-analyses suggest isometric resistance training (IRT) may be superior to aerobic exercise for lowering blood pressure. A randomised controlled study will be conducted with participants who are either pre-hypertensive, blood pressure between 120/80 and 140/90, or on medication to control their blood pressure. Previous studies have utilised a sedentary control so we intend to use a sham group to determine if it can be used as a working control for future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| IHG 5% Hypertensive | Sham comparator | Other: Isometric resistance trainingParticipants who are either un-medicated pre-hypertensive or medicated for blood pressure management conducting isometric resistance training using a hand dynamometer at 5% of their maximum voluntary contraction. Participants with perform 4 x 2 minutes isometric handgrip exercises 3 times per week under supervision for 8 weeks. |
| IHG 30% Hypertensive | Experimental | Other: Isometric resistance trainingParticipants who are either un-medicated pre-hypertensive or medicated for blood pressure management conducting isometric resistance training using a hand dynamometer at 30% of their maximum voluntary contraction. Participants with perform 4 x 2 minutes isometric handgrip exercises 3 times per week under supervision for 8 weeks. |
| IHG 30% Normotensive | Experimental | Other: Isometric resistance trainingParticipants who are normotensive conducting isometric resistance training using a hand dynamometer at 30% of their maximum voluntary contraction. Participants with perform 4 x 2 minutes isometric handgrip exercises 3 times per week under supervision for 8 weeks. |
| IHG 5% Normotensive | Sham comparator | Other: Isometric resistance trainingParticipants who are normotensive conducting isometric resistance training using a hand dynamometer at 5% of their maximum voluntary contraction. Participants with perform 4 x 2 minutes isometric handgrip exercises 3 times per week under supervision for 8 weeks. |
| IHG 10% Hypertensive | Experimental | Other: Isometric resistance trainingParticipants who are either un-medicated pre-hypertensive or medicated for blood pressure management conducting isometric resistance training using a hand dynamometer at 10% of their maximum voluntary contraction. Participants with perform 4 x 2 minutes isometric handgrip exercises 3 times per week under supervision for 8 weeks. |
| IHG 10% Normotensive | Experimental | Other: Isometric resistance trainingParticipants who are normotensive conducting isometric resistance training using a hand dynamometer at 10% of their maximum voluntary contraction. Participants with perform 4 x 2 minutes isometric handgrip exercises 3 times per week under supervision for 8 weeks. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Those within the required age limits, both normotensive, pre-hypertensive, and those medicated for blood pressure management.
Key exclusion criteria (1 listed)
- Younger than 30 years and older than 70 years; those deemed not to have the capacity to voluntarily participate, unable to participate under their doctor's recommendation, or with arthritis or carpal tunnel syndrome who may aggravate their condition 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 exercise using a hand dynamometer. | Other | IHG 10% Hypertensive, IHG 10% Normotensive, IHG 30% Hypertensive, IHG 30% Normotensive, IHG 5% Hypertensive, IHG 5% Normotensive |
Primary outcome
Change in systolic and diastolic blood pressure
Time frame: Baseline and 8 weeks
2 secondary outcomes
Compare and contrast changes in blood pressure between the 5% maximum voluntary contraction (MVC) and 30% MVC hypertensive groups
Time frame: Baseline and 8 weeks
Compare and contrast blood pressure changes between the 30% maximum voluntary contraction (MVC) hypertensive and 30% MVC normotensive groups
Time frame: Baseline and 8 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 1 inclusion and 1 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: Baseline and 8 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 NCT02458456, 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.