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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthumbria University

About this trial

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 study, participants will be interviewed to gather their views and opinions on the programme. Changes in blood pressure will be evaluated at 12 and 24 weeks.

By exploring whether lifestyle advice and 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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. Participants may engage in habitual physical activity; however, those meeting current physical activity recommendations (≥150 min·week-¹ of moderate-intensity or ≥75 min·week-¹ of vigorous-intensity activity, or an equivalent combination) will be excluded. Physical activity levels will be ascertained using the International Physical Activity Questionnaire (IPAQ).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Isometric Exercise and Lifestyle Change Advice

    Behavioral

    The intervention consists of two distinct phases: • Intensive Phase (12 weeks) - a structured, high-support period involving three weekly supervised isometric exercise sessions and lifestyle change advice. The supervised exercise programme will consist of 4 × 2-minute bouts of wall squat exercise, with 2-minute rest periods between bouts. Participant squat height position will be based on individual calculations determined at baseline. Target rate of perceived exertion (RPE) for each bout will be: * Bout 1: RPE 4 (target range: 3.5-4.5) * Bout 2: RPE 5.5 (target range: 5-6) * Bout 3: RPE 7 (target range: 6.5-7.5) * Bout 4: RPE 8.5 (target range: 8-9) If the RPE falls outside the target zone for a given bout, participants will adjust their squat height accordingly. Lifestyle change advice will be given in booklet form in accordance with current NICE guidelines for hypertension. • Maintenance Phase (12-24 weeks) - focus on sustaining exercise and lifestyle behaviour changes

  • Lifestyle Change Advice

    Behavioral

    Lifestyle change advice given as per current standard care for hypertension

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Home Based Isometric Exercise and Lifestyle Change GroupExperimental treatment 1 intervention
Group B: Lifestyle Change Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of Intervention

Feasibility will be determined by the rate of screening, eligibility, recruitment, and retention at 12 and 24 weeks.

Time frame
Baseline to 24 weeks
2

Feasibility of Intervention

Feasibility will be determined by adherence to the intervention (number of sessions attended and completed)

Time frame
Baseline to 24 weeks
3

Acceptability of Intervention

Participant acceptability will be determined through a qualitative process evaluation involving semi-structured interviews. The interviews will explore experience with study participation (informed consent process, time commitment), the acceptability of measures (readability, burden), and experiences, thoughts, and attitudes toward current usual care.

Time frame
Post 24 weeks

Secondary outcomes

1

Office and Ambulatory Blood Pressure

Blood pressure will be measured in mmHg via office and ambulatory methods. Office BP will be taken in a seated position in accordance with resting BP protocols. Ambulatory BP monitoring will be performed with a non-invasive oscillometric device placed on the nondominant arm and programmed to perform measurements every 15 minutes for 24 hours. The secondary outcome is the change in mmHg for systolic and diastolic blood pressure from baseline, 12 weeks, and 24 weeks.

Time frame
Baseline to 24 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northumbria University

Lead sponsor

HealthWorks Newcastle Upon Tyne

Collaborator