NCT02458443

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 Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Feb 2016

Shorter than P25 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

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Study Timeline

Key milestones and dates

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
8 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day 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

10 months

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

    Change measures: baseline and 12 weeks

Secondary Outcomes (2)

  • Compare and contrast change in systolic and diastolic blood pressure of medicated and un-medicated participants

    Baseline and 12 weeks

  • Detraining effects, changes in systolic and diastolic blood pressure after cessation of Isometric Resistance Training

    12 weeks and 24 weeks

Study Arms (4)

IHG 5% Un-medicated

SHAM COMPARATOR

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.

Other: Isometric resistance training

IHG 5% BB

SHAM COMPARATOR

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.

Other: Isometric resistance training

IHG 30% Un-medicated

EXPERIMENTAL

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.

Other: Isometric resistance training

IHG 30% BB

EXPERIMENTAL

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: Isometric resistance training

Interventions

Isometric handgrip exercise using a hand dynamometer

IHG 30% BBIHG 30% Un-medicatedIHG 5% BBIHG 5% Un-medicated

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNE Exercise Physiology Lab

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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
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

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations