- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02458443
Isometric Handgrip Exercise for Blood Pressure Management
December 14, 2020 updated by: Deb Carlson, University of New England, Australia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
80
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
- UNE Exercise Physiology Lab
-
-
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:
- 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.
Exclusion Criteria:
- 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:
- obesity,
- insulin resistance,
- depression,
- mobility impairment,
- sleep apnoea,
- fatty liver disease or
- renal disease
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: IHG 5% Un-medicated
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.
|
Isometric handgrip exercise using a hand dynamometer
|
|
Sham Comparator: IHG 5% BB
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.
|
Isometric handgrip exercise using a hand dynamometer
|
|
Experimental: IHG 30% Un-medicated
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.
|
Isometric handgrip exercise using a hand dynamometer
|
|
Experimental: IHG 30% BB
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.
|
Isometric handgrip 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: Change measures: baseline and 12 weeks
|
Change measures: baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compare and contrast change in systolic and diastolic blood pressure of medicated and un-medicated participants
Time Frame: Baseline and 12 weeks
|
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
|
End of exercise protocol and 12 weeks after completion
|
12 weeks and 24 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 (Actual)
February 1, 2016
Primary Completion (Actual)
December 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
- UNewEngland
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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