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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
80
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, Australia
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/study/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.
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



Summary Results

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