Feasibility and Acceptability of Isometric Exercise and Lifestyle Change for the Management of Hypertension

Northumbria University

Status: Enrolling

Conditions: Hypertension (HTN)

Treatments: Behavioral: Lifestyle Change Advice; Behavioral: Isometric Exercise and Lifestyle Change Advice

Study type: Interventional

Funder types: Other

Identifiers

NCT07213479

10198 (Registry Identifier)

Details and patient eligibility

About

High blood pressure (hypertension) is a leading risk factor for cardiovascular diseases and may contribute to poor health and premature death. The purpose of this research is to learn if a home-based isometric exercise programme combined with lifestyle change advice is a practical and acceptable method for people diagnosed with hypertension to manage their condition. Isometric exercise involves a muscle contraction without movement of the limbs and previous research has shown this may be effective for reducing blood pressure. Therefore, this study will explore the experiences, thoughts, attitudes, and barriers to participation. It will also examine the effect the isometric exercise has on blood pressure.

Participants will undertake an isometric exercise programme using a wall squat position, 3 times per week, for 12 weeks. The exercise sessions will be completed at home with remote online supervision by an exercise professional. Lifestyle change advice will given in line with current guidelines to promote healthy behaviours to reduce high blood pressure. After 12 weeks, participants will be encouraged to continue with the wall squat exercise for a further 12-weeks unsupervised. Throughout the study, participants' blood pressure and daily activity will be recorded using a smartwatch device.

Upon completion of the intervention period, participants will be interviewed to gather their views and opinions on the isometric exercise programme. Changes in blood pressure will be evaluated at 12 and 24 weeks.

By exploring whether an isometric exercise programme is a feasible and acceptable method for hypertensive people to manage their condition and how this influences blood pressure, this research may aid in the development of a strategy to manage hypertension.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Arterial Hypertension (AH) in accordance with NICE guidelines.
• Under pharmacological treatment for AH with antihypertensive drug, type and dose maintained for the previous four months.
• Blood Pressure with values <180 and <110 mmHg for office systolic and diastolic BP, respectively.
• Not currently engaged in any structured or supervised exercise training programme, including resistance, aerobic, or isometric exercise, defined as planned exercise performed ≥2 times per week at moderate or greater intensity, for at least three months prior to enrolment.
• Written informed consent provided.

Exclusion criteria

• Body mass index >35 kg/m2.
• Presence of cardiovascular disease beyond hypertension.
• Known orthopaedic, musculoskeletal, or neurological conditions that restrain isometric exercise execution.
• Presence of secondary hypertension
• Inability to follow verbal instructions or complete study protocol

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Home Based Isometric Exercise and Lifestyle Change Group

Experimental group

Description:

Participants randomised to this group will undertake a remotely supervised 12-week home-based isometric exercise training intervention 3 times per week. The bilateral leg isometric exercise consists of 5-stage wall squat position determined by individual calculations at baseline. Rate of perceived exertion (RPE) will be monitored throughout the intervention and used to guide the squat stage position. Lifestyle change advice will be given in accordance with NICE guidelines for hypertension. Participants will receive a smartwatch (Huawei D2) to monitor their daily physical activity (step count) and record their home blood pressure.

Treatment:

Behavioral: Isometric Exercise and Lifestyle Change Advice

Lifestyle Change Control Group

Active Comparator group

Description:

Participants randomised to this group will not receive any intervention other than lifestyle change advice in accordance with NICE guidelines for hypertension. Participants will receive a smartwatch (Huawei D2) to monitor their daily physical activity (step count) and record their home blood pressure.

Treatment:

Behavioral: Lifestyle Change Advice