- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02458456
Isometric Handgrip Exercise for Blood Pressure Management
December 14, 2020 updated by: Deb Carlson, University of New England, Australia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Armidale, New South Wales, Australia, 2351
- University of New England
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Those within the required age limits, both normotensive, pre-hypertensive, and those medicated for blood pressure management.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: IHG 5% Hypertensive
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.
|
Isometric exercise using a hand dynamometer.
|
|
Experimental: IHG 30% Hypertensive
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.
|
Isometric exercise using a hand dynamometer.
|
|
Experimental: IHG 30% Normotensive
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.
|
Isometric exercise using a hand dynamometer.
|
|
Sham Comparator: IHG 5% Normotensive
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.
|
Isometric exercise using a hand dynamometer.
|
|
Experimental: IHG 10% Hypertensive
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.
|
Isometric exercise using a hand dynamometer.
|
|
Experimental: IHG 10% Normotensive
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.
|
Isometric exercise using a hand dynamometer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in systolic and diastolic blood pressure
Time Frame: Baseline and 8 weeks
|
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
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
|
Baseline and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Neil Smart, PhD, University of New England
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
May 21, 2015
First Submitted That Met QC Criteria
May 27, 2015
First Posted (Estimate)
June 1, 2015
Study Record Updates
Last Update Posted (Actual)
December 17, 2020
Last Update Submitted That Met QC Criteria
December 14, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNewEngland1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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