Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02458456




Registration number
NCT02458456
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
Scientific title
Isometric Handgrip Exercise for Blood Pressure Management. A Randomized, Controlled Trial
Secondary ID [1] 0 0
UNewEngland1
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% 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.

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.

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.

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.

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.

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.


Other interventions: Isometric resistance training
Isometric 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
Baseline and 8 weeks
Secondary outcome [1] 0 0
Compare and contrast changes in blood pressure between the 5% maximum voluntary contraction (MVC) and 30% MVC hypertensive groups
Timepoint [1] 0 0
Baseline and 8 weeks
Secondary outcome [2] 0 0
Compare and contrast blood pressure changes between the 30% maximum voluntary contraction (MVC) hypertensive and 30% MVC normotensive groups
Timepoint [2] 0 0
Baseline and 8 weeks

Eligibility
Key inclusion criteria
- Those within the required age limits, both normotensive, pre-hypertensive, and those
medicated for blood pressure management.
Minimum age
30 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 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


Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of New England - Armidale
Recruitment postcode(s) [1] 0 0
2351 - Armidale

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

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02458456
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.
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries