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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02458443




Registration number
NCT02458443
Ethics application status
Date submitted
21/05/2015
Date registered
1/06/2015
Date last updated
2/08/2016

Titles & IDs
Public title
Isometric Handgrip Exercise for Blood Pressure Management
Scientific title
Cardiovascular Response to Isometric Resistance Training in People With Hypertension for Blood Pressure Management
Secondary ID [1] 0 0
UNewEngland
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in systolic and diastolic blood pressure
Timepoint [1] 0 0
Change measures: baseline and 12 weeks
Secondary outcome [1] 0 0
Compare and contrast change in systolic and diastolic blood pressure of medicated and un-medicated participants
Timepoint [1] 0 0
Baseline and 12 weeks
Secondary outcome [2] 0 0
Detraining effects, changes in systolic and diastolic blood pressure after cessation of Isometric Resistance Training - End of exercise protocol and 12 weeks after completion
Timepoint [2] 0 0
12 weeks and 24 weeks

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.
Minimum age
30 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
UNE Exercise Physiology Lab - Armidale
Recruitment postcode(s) [1] 0 0
2351 - Armidale

Funding & Sponsors
Primary sponsor type
Other
Name
University of New England
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02458443
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. Review.
Public notes

Contacts
Principal investigator
Name 0 0
Neil Smart, PhD
Address 0 0
University of New England
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Neil Smart, PhD
Address 0 0
Country 0 0
Phone 0 0
02 6773 4076
Fax 0 0
Email 0 0
nsmart2@une.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02458443