Isometric Exercise for People With Raised Blood Pressure (IsoFIT-BP)

East Kent Hospitals University NHS Foundation Trust

Status: Completed

Conditions: Hypertension

Treatments: Other: Isometric Exercise; Behavioral: Standard care lifestyle advice

Study type: Interventional

Funder types: Other

Identifiers

NCT04936022

13472393 (Registry Identifier)

NIHR200485

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Control

Other group

Description:

To receive standard care lifestyle advice only

Treatment:

Behavioral: Standard care lifestyle advice

Isometric Exercise

Experimental group

Description:

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

Treatment:

Behavioral: Standard care lifestyle advice

Other: Isometric Exercise