NCT02458456

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

2.3 years

First QC Date

May 21, 2015

Last Update Submit

December 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in systolic and diastolic blood pressure

    Baseline and 8 weeks

Secondary Outcomes (2)

  • Compare and contrast changes in blood pressure between the 5% maximum voluntary contraction (MVC) and 30% MVC hypertensive groups

    Baseline and 8 weeks

  • Compare and contrast blood pressure changes between the 30% maximum voluntary contraction (MVC) hypertensive and 30% MVC normotensive groups

    Baseline and 8 weeks

Study Arms (6)

IHG 5% Hypertensive

SHAM COMPARATOR

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.

Other: Isometric resistance training

IHG 30% Hypertensive

EXPERIMENTAL

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.

Other: Isometric resistance training

IHG 30% Normotensive

EXPERIMENTAL

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.

Other: Isometric resistance training

IHG 5% Normotensive

SHAM COMPARATOR

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.

Other: Isometric resistance training

IHG 10% Hypertensive

EXPERIMENTAL

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.

Other: Isometric resistance training

IHG 10% Normotensive

EXPERIMENTAL

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: Isometric resistance training

Interventions

Isometric exercise using a hand dynamometer.

IHG 10% HypertensiveIHG 10% NormotensiveIHG 30% HypertensiveIHG 30% NormotensiveIHG 5% HypertensiveIHG 5% Normotensive

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those within the required age limits, both normotensive, pre-hypertensive, and those medicated for blood pressure management.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New England

Armidale, New South Wales, 2351, Australia

Location

Related Publications (1)

  • 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.

    PMID: 24582191BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Neil Smart, PhD

    University of New England

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

May 21, 2015

First Posted

June 1, 2015

Study Start

August 1, 2014

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations