Isometric Exercise for People With Raised Blood Pressure

NCT ID: NCT04936022

Last Updated: 2023-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-11-30

Brief Summary

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High blood pressure affects many people in the United Kingdom. People with raised blood pressure (140-159/90-99 mmHg) are recommended to make changes in their lifestyle (e.g. smoking/alcohol/diet/exercise) and/or medication in order to reduce their blood pressure. Current knowledge suggests that a particular type of exercise - isometric exercise - can lower blood pressure. Isometric exercise involves holding a fixed body position for a short period of time. As most of the information about the benefits of this type of exercise comes from laboratory-based studies, researchers want to find out if it is possible for GP practices to offer NHS patients with clinically high blood pressure an isometric exercise plan to do at home and how it might affect their blood pressure over 6 months. They will also find out the experiences of those doing this type of exercise and whether it can be done consistently at home over time.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multi-centre randomized controlled feasibility study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

To receive standard care lifestyle advice only

Group Type OTHER

Standard care lifestyle advice

Intervention Type BEHAVIORAL

Healthy lifestyle advice for hypertension, given by a healthcare professional.

Isometric Exercise

To receive standard care lifestyle advice plus 3 sessions of isometric exercise per week

Group Type EXPERIMENTAL

Isometric Exercise

Intervention Type OTHER

Prescribed 6 months of isometric exercise training (three sessions per week, comprised of 4 x 2-minute bouts with 2-minute recovery periods in-between).

Standard care lifestyle advice

Intervention Type BEHAVIORAL

Healthy lifestyle advice for hypertension, given by a healthcare professional.

Interventions

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Isometric Exercise

Prescribed 6 months of isometric exercise training (three sessions per week, comprised of 4 x 2-minute bouts with 2-minute recovery periods in-between).

Intervention Type OTHER

Standard care lifestyle advice

Healthy lifestyle advice for hypertension, given by a healthcare professional.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Aged 18 or over
* Clinic systolic BP 140-159 mmHg
* Able to provide informed consent

Exclusion Criteria

* Currently taking anti-hypertensive medication
* White coat hypertension, as evidenced by averaged home systolic BP \<135 mmHg
* Inability to undertake study intervention (isometric exercise)
* Previous history of any of the following:

* Diabetes mellitus (Type 1 or type 2)
* Ischaemic heart disease (myocardial infarction and/or coronary angina and/or coronary revascularization procedure)
* Moderate or severe stenotic or regurgitant heart valve disease
* Atrial or ventricular arrhythmia
* Stroke or transient ischaemic attack
* Aortic aneurysm and/or peripheral arterial disease
* Uncorrected congenital or inherited heart condition
* Estimated glomerular filtration rate \<45 ml/min (calculated using CKD-EPI or MDRD formulae, and taking most recent documented results)
* Documented left ventricular ejection fraction \<45% and/or left ventricular hypertrophy (by either echocardiography or standard ECG criteria e.g. Sokolow-Lyon)
* Documented urine albumin:creatinine ratio \>3.5 mg/mmol
* Inability to provide informed consent
* If female, pregnancy or currently breast feeding
* Enrolled in another Clinical Trial of an Interventional Medicinal Product or Medical Device or other interventional study
* Medical condition that, in the opinion of the investigator, would make the participant unsuitable for the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kent

OTHER

Sponsor Role collaborator

Canterbury Christ Church University

OTHER

Sponsor Role collaborator

East Kent Hospitals University NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher K Farmer

Role: STUDY_DIRECTOR

University of Kent

Locations

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Canterbury Medical Practice

Canterbury, Kent, United Kingdom

Site Status

Kent and Canterbury Hospital

Canterbury, Kent, United Kingdom

Site Status

Newton Place Surgery

Faversham, Kent, United Kingdom

Site Status

St Helier Hospital

Carshalton, Surrey, United Kingdom

Site Status

Maywood Healthcare Centre

Bognor Regis, West Sussex, United Kingdom

Site Status

Brighton Health and Wellbeing Centre

Hove, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Wiles JD, Santer E, Rees-Roberts M, Borthwick R, Doulton T, Swift PA, Pellatt-Higgins T, Saxby K, Mills A, Gousia K, MacInnes D, O'Driscoll J, West A, Darby J, Short V, Farmer CK. Feasibility randomised controlled trial to assess the delivery of a novel isometric exercise intervention for people diagnosed with uncomplicated stage 1 hypertension in the National Health Service: key quantitative findings. BMJ Open. 2025 Jun 4;15(6):e091219. doi: 10.1136/bmjopen-2024-091219.

Reference Type DERIVED
PMID: 40467325 (View on PubMed)

Other Identifiers

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13472393

Identifier Type: REGISTRY

Identifier Source: secondary_id

NIHR200485

Identifier Type: -

Identifier Source: org_study_id

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