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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02458443
Registration number
NCT02458443
Ethics application status
Date submitted
21/05/2015
Date registered
1/06/2015
Date last updated
17/12/2020
Titles & IDs
Public title
Isometric Handgrip Exercise for Blood Pressure Management
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Scientific title
Cardiovascular Response to Isometric Resistance Training in People With Hypertension for Blood Pressure Management
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Secondary ID [1]
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UNewEngland
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypertension
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Condition category
Condition code
Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Isometric resistance training
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.
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.
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.
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.
Other interventions: Isometric resistance training
Isometric handgrip exercise using a hand dynamometer
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in systolic and diastolic blood pressure
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Assessment method [1]
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Timepoint [1]
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Change measures: baseline and 12 weeks
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Secondary outcome [1]
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Compare and contrast change in systolic and diastolic blood pressure of medicated and un-medicated participants
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Assessment method [1]
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Timepoint [1]
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Baseline and 12 weeks
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Secondary outcome [2]
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Detraining effects, changes in systolic and diastolic blood pressure after cessation of Isometric Resistance Training
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Assessment method [2]
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End of exercise protocol and 12 weeks after completion
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Timepoint [2]
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12 weeks and 24 weeks
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Eligibility
Key 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.
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Minimum age
30
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Factorial
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2016
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Sample size
Target
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Accrual to date
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Final
80
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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UNE Exercise Physiology Lab - Armidale
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Recruitment postcode(s) [1]
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2351 - Armidale
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of New England, Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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 hypertension.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02458443
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
Name
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Neil Smart, PhD
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Address
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University of New England
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02458443
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