Isometric Exercise for People With Raised Blood Pressure

East Kent Hospitals University NHS Foundation Trust84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Canterbury Medical Practice

Canterbury, Kent, United Kingdom

Kent and Canterbury Hospital

Canterbury, Kent, United Kingdom

Newton Place Surgery

Faversham, Kent, United Kingdom

St Helier Hospital

Carshalton, Surrey, United Kingdom

Maywood Healthcare Centre

Bognor Regis, West Sussex, United Kingdom

Brighton Health and Wellbeing Centre

Hove, United Kingdom

Outcomes

Primary Outcomes

Experience of intervention delivery

Qualitative focus groups with health care professionals identifying the type and number of each barrier and facilitator, of the practical delivery of isometric exercise intervention.

Time frame: Project month 11

Change in systolic blood pressure (mmHg) from baseline to Week 4.

Time frame: Participant week 4

Change in systolic blood pressure (mmHg) from baseline to Month 3.

Time frame: Participant 3 months

Change in systolic blood pressure (mmHg) from baseline to Month 6.

Time frame: Participant 6 months

Secondary Outcomes

Early fidelity of the isometric exercise prescription.

Assessed by checking whether individual participant's heart rate (bpm) measures fall within 95% of their peak heart rate confidence intervals following the first three training sessions.

Time frame: Participant week 1

Short-term fidelity of the isometric exercise prescription.

Assessed by checking whether individual participant's heart rate (bpm) measures fall within 95% of their peak heart rate confidence intervals following the first four weeks (12) of training sessions.

Time frame: Participant week 4

Short-term adherence to the Isometric exercise (IE) training.

Measured using the proportion of participants (number) completing a minimum of 8 of 12 IE sessions up to the 4-week point.

Time frame: Participant week 4

Mid-term adherence to the Isometric exercise training.

Measured using the proportion of participants (number) completing a minimum of two thirds of all IE sessions up to 3 months.

Time frame: Participant 3 Months

Long-term adherence to the Isometric exercise training.

Measured using the proportion of participants (number) completing a minimum of two thirds of all IE sessions up to 6 months.

Time frame: Participant 6 Months

Recruitment rates from data collected at sites.

This will be measured by calculating the average number of participants recruited per week.

Time frame: Project month 10

Short-term attrition rates from data collected at sites.

This will be measured by calculating the number of withdrawals from the study up to 4 weeks.

Time frame: Participant week 4

Mid-term attrition rates from data collected at sites.

This will be measured by calculating the number of withdrawals from the study up to 3 months.

Time frame: Participant 3 months

Long-term attrition rates from data collected at sites.

This will be measured by calculating the number of withdrawals from the study up to 6 months.

Time frame: Participant 6 months

Change in diastolic blood pressure (mmHg) from baseline to Week 4.

Time frame: Week 4

Change in diastolic blood pressure (mmHg) from baseline to Month 3.

Time frame: Month 3

Change in diastolic blood pressure (mmHg) from baseline to Month 6.

Time frame: Month 6

Experience of isometric exercise intervention.

Qualitative focus groups with study participants identifying the number of positive and negative experiences of the isometric exercise intervention and taking part in the study.

Time frame: Month 11

Participant experiences of undertaking isometric exercise.

Collected using participant study-specific survey with closed and open questions.

Time frame: Participant week 4.

Subjective opinion of healthcare professionals on their willingness to consider the intervention as a treatment option for patients with Stage 1 hypertension.

Collected using semi-structured interviews conducted by telephone with healthcare professionals from GP practices not taking part as study recruitment sites.

Time frame: Project month 11.

Short-term Quality-adjusted life years (QALYs) calculated from patients' responses to the EQ-5D-5L questionnaire.

The health profile established from EQ-5D-5L will be converted into a utility index (0 and 1) using the validated mapping function to derive utility values for EQ-5D-5L from the existing EQ-5D-3L. These utilities will be multiplied by the time spent in each state to generate QALYs.

Time frame: Participant 4 weeks

Mid-term Quality-adjusted life years calculated from patients' responses to the EQ-5D-5L questionnaire.

Time frame: Participant 3 months

Long-term Quality-adjusted life years calculated from patients' responses to the EQ-5D-5L questionnaire.

Time frame: Participant 6 months

Healthcare resource utilisation (a).

Measuring healthcare access by using the number of GP visits at 4 weeks.

Time frame: Participant 4 weeks.

Healthcare resource utilisation (a).

Measuring healthcare access by using the number of GP visits at 3 months.

Time frame: Participant 3 months

Healthcare resource utilisation (a).

Measuring healthcare access by using the number of GP visits at 6 months.

Time frame: Participant 6 months

Healthcare resource utilisation (b).

Measuring healthcare access by using the number of nurse visits at 4 weeks.

Time frame: Participant 4 weeks.

Healthcare resource utilisation (b).

Measuring healthcare access by using the number of nurse visits at 3 months.

Time frame: Participant 3 months.

Healthcare resource utilisation (b).

Measuring healthcare access by using the number of nurse visits at 6 months.

Time frame: Participant 6 months.

Healthcare resource utilisation (c).

Measuring healthcare access by using the number of other health professionals visits at 4 weeks.

Time frame: Participant 4 weeks.

Healthcare resource utilisation (c).

Measuring healthcare access by using the number of other health professionals visits at 3 months.

Time frame: Participant 3 months.

Healthcare resource utilisation (c).

Measuring healthcare access by using the number of other health professionals visits at 6 months.

Time frame: Participant 6 months.

Healthcare resource utilisation (d).

Measuring healthcare access by using the number of number of A\&E attendances at 4 weeks.

Time frame: Participant 4 weeks.

Healthcare resource utilisation (d).

Measuring healthcare access by using the number of number of A\&E attendances at 3 months.

Time frame: Participant 3 months.

Healthcare resource utilisation (d).

Measuring healthcare access by using the number of number of A\&E attendances at 6 months.

Time frame: Participant 6 months.

Healthcare resource utilisation (e).

Measuring healthcare access by using the number of number of inpatient hospital admissions at 4 weeks.

Time frame: Participant 4 weeks.

Healthcare resource utilisation (e).

Measuring healthcare access by using the number of number of inpatient hospital admissions at 3 months.

Time frame: Participant 3 months.

Healthcare resource utilisation (e).

Measuring healthcare access by using the number of inpatient hospital admissions at 6 months.

Time frame: Participant 6 months.

Healthcare resource utilisation (f).

Measuring healthcare access by using the number of inpatient diagnostic tests at 4 weeks.

Time frame: Participant 4 weeks.

Healthcare resource utilisation (f).

Measuring healthcare access by using the number of inpatient diagnostic tests at 3 months.

Time frame: Participant 3 months.

Healthcare resource utilisation (f).

Measuring healthcare access by using the number of inpatient diagnostic tests at 6 months.

Time frame: Participant 6 months.

Intervention costs.

This will be measured by calculating the time cost of the training team and healthcare professionals, the cost of supplies and the equipment necessary to implement the intervention.

Time frame: Participant 4 weeks.

Intervention costs.

This will be measured by. calculating the time cost of the training team and healthcare professionals, the cost of supplies and the equipment necessary to implement the intervention.

Time frame: Participant 3 months.

Intervention costs

This will be measured by calculating the time cost of the training team and healthcare professionals, the cost of supplies and the equipment necessary to implement the intervention.

Time frame: Participant 6 months.

Medication at short-term time point (a)

Measured using the frequency per week in days, start and end date per medication at 4 weeks.

Time frame: Participant 4 weeks.

Medication at mid-term time point (a)

Measuring the frequency per week in days, start and end date per medication at 3 months.

Time frame: Participant 3 months.

Medication at long-term time point (a)

Measuring the frequency per week in days, start and end date per medication at 6 months.

Time frame: Participant 6 months.

Medication at short-term time point (b)

Measured using the dosage per day (mg), start and end date per medication at 4 weeks.

Time frame: Participant 4 weeks.

Medication at mid-term time point (b)

Measuring the dosage per day (mg), start and end date per medication at 3 months.

Time frame: Participant 3 months.

Medication at long-term time point (b)

Measuring the dosage per day (mg), start and end date per medication at 6 months.

Time frame: Participant 6 months.