Isometric Exercise for People With Raised Blood Pressure
- Conditions
- Hypertension
- Interventions
- Other: Isometric ExerciseBehavioral: Standard care lifestyle advice
- Registration Number
- NCT04936022
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- Aged 18 or over
- Clinic systolic BP 140-159 mmHg
- Able to provide informed consent
-
Currently taking anti-hypertensive medication
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White coat hypertension, as evidenced by averaged home systolic BP <135 mmHg
-
Inability to undertake study intervention (isometric exercise)
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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)
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Documented left ventricular ejection fraction <45% and/or left ventricular hypertrophy (by either echocardiography or standard ECG criteria e.g. Sokolow-Lyon)
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Documented urine albumin:creatinine ratio >3.5 mg/mmol
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Isometric Exercise Isometric Exercise To receive standard care lifestyle advice plus 3 sessions of isometric exercise per week Control Standard care lifestyle advice To receive standard care lifestyle advice only Isometric Exercise Standard care lifestyle advice To receive standard care lifestyle advice plus 3 sessions of isometric exercise per week
- Primary Outcome Measures
Name Time Method Change in systolic blood pressure (mmHg) from baseline to Week 4. Participant week 4 Change in systolic blood pressure (mmHg) from baseline to Month 3. Participant 3 months Change in systolic blood pressure (mmHg) from baseline to Month 6. Participant 6 months Experience of intervention delivery Project month 11 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.
- Secondary Outcome Measures
Name Time Method Mid-term attrition rates from data collected at sites. Participant 3 months This will be measured by calculating the number of withdrawals from the study up to 3 months.
Medication at short-term time point (a) Participant 4 weeks. Measured using the frequency per week in days, start and end date per medication at 4 weeks.
Short-term fidelity of the isometric exercise prescription. Participant week 4 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.
Short-term adherence to the Isometric exercise (IE) training. Participant week 4 Measured using the proportion of participants (number) completing a minimum of 8 of 12 IE sessions up to the 4-week point.
Long-term attrition rates from data collected at sites. Participant 6 months This will be measured by calculating the number of withdrawals from the study up to 6 months.
Healthcare resource utilisation (a). Participant 6 months Measuring healthcare access by using the number of GP visits at 6 months.
Intervention costs Participant 6 months. 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.
Medication at long-term time point (a) Participant 6 months. Measuring the frequency per week in days, start and end date per medication at 6 months.
Medication at mid-term time point (a) Participant 3 months. Measuring the frequency per week in days, start and end date per medication at 3 months.
Medication at mid-term time point (b) Participant 3 months. Measuring the dosage per day (mg), start and end date per medication at 3 months.
Healthcare resource utilisation (f). Participant 6 months. Measuring healthcare access by using the number of inpatient diagnostic tests at 6 months.
Medication at long-term time point (b) Participant 6 months. Measuring the dosage per day (mg), start and end date per medication at 6 months.
Healthcare resource utilisation (e). Participant 6 months. Measuring healthcare access by using the number of inpatient hospital admissions at 6 months.
Early fidelity of the isometric exercise prescription. Participant week 1 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.
Mid-term adherence to the Isometric exercise training. Participant 3 Months Measured using the proportion of participants (number) completing a minimum of two thirds of all IE sessions up to 3 months.
Long-term adherence to the Isometric exercise training. Participant 6 Months Measured using the proportion of participants (number) completing a minimum of two thirds of all IE sessions up to 6 months.
Recruitment rates from data collected at sites. Project month 10 This will be measured by calculating the average number of participants recruited per week.
Change in diastolic blood pressure (mmHg) from baseline to Week 4. Week 4 Change in diastolic blood pressure (mmHg) from baseline to Month 3. Month 3 Experience of isometric exercise intervention. Month 11 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.
Participant experiences of undertaking isometric exercise. Participant week 4. Collected using participant study-specific survey with closed and open questions.
Healthcare resource utilisation (c). Participant 6 months. Measuring healthcare access by using the number of other health professionals visits at 6 months.
Short-term attrition rates from data collected at sites. Participant week 4 This will be measured by calculating the number of withdrawals from the study up to 4 weeks.
Change in diastolic blood pressure (mmHg) from baseline to Month 6. Month 6 Subjective opinion of healthcare professionals on their willingness to consider the intervention as a treatment option for patients with Stage 1 hypertension. Project month 11. Collected using semi-structured interviews conducted by telephone with healthcare professionals from GP practices not taking part as study recruitment sites.
Short-term Quality-adjusted life years (QALYs) calculated from patients' responses to the EQ-5D-5L questionnaire. Participant 4 weeks 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.
Mid-term Quality-adjusted life years calculated from patients' responses to the EQ-5D-5L questionnaire. Participant 3 months 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.
Long-term Quality-adjusted life years calculated from patients' responses to the EQ-5D-5L questionnaire. Participant 6 months 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.
Healthcare resource utilisation (b). Participant 6 months. Measuring healthcare access by using the number of nurse visits at 6 months.
Healthcare resource utilisation (d). Participant 6 months. Measuring healthcare access by using the number of number of A\&E attendances at 6 months.
Medication at short-term time point (b) Participant 4 weeks. Measured using the dosage per day (mg), start and end date per medication at 4 weeks.
Intervention costs. Participant 3 months. 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.
Trial Locations
- Locations (6)
Brighton Health and Wellbeing Centre
🇬🇧Hove, United Kingdom
St Helier Hospital
🇬🇧Carshalton, Surrey, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, Kent, United Kingdom
Canterbury Medical Practice
🇬🇧Canterbury, Kent, United Kingdom
Newton Place Surgery
🇬🇧Faversham, Kent, United Kingdom
Maywood Healthcare Centre
🇬🇧Bognor Regis, West Sussex, United Kingdom