Stage 1 hypertensive patients (defined as a clinic BP of 140-159/90-99 mmHg) who are not taking anti-hypertension medication Circulatory System Hypertensive diseases
Conditions
Interventions
Participants will be randomized into two groups, the intervention arm and the control arm, in a 1:1 ratio using sealed envelope software. Both groups will receive standard care/lifestyle advice and ha
Sponsors
East Kent Hospitals University NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 or over 2. Clinic systolic BP 140-159 mmHg 3. Able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Currently taking anti-hypertensive medication 2. White coat hypertension, as evidenced by averaged home systolic BP 3.5 mg/mmol 8. Inability to provide informed consent 9. If female, pregnancy or currently breastfeeding 10. Enrolled in another Clinical Trial of an Interventional Medicinal Product or Medical Device or another interventional study 11. Medical condition that, in the opinion of the investigator, would make the participant unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 07/01/2022: 1. Feasibility of isometric exercise prescription assessed using qualitative data from healthcare professional focus groups at month 11/12 of the study 2. Variance of blood pressure changes from baseline using participant blood pressure data at week 4, months 3 and 6 3. Sample size for a definitive randomised controlled trial, calculated using evidence of effect on participant systolic blood pressure change at week 1, months 3 and 6 Previous primary outcome measure: 1. Feasibility of isometric exercise prescription assessed using qualitative data from healthcare professional focus groups at month 11/12 of the study 2. Feasibility of isometric exercise intervention and study assessed using qualitative data from participants at month 7 and 11 of the study 3. Variance of blood pressure changes from baseline using participant blood pressure data at week 4, months 3 and 6 4. Sample size for a definitive randomised controlled trial, calculated using evidence of effect on participant systolic blood pressure change at week 1, months 3 and 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 07/01/2022: 1. Fidelity of the isometric exercise prescription measured using prescription competency assessment data at month 3 2. Fidelity of the isometric exercise prescription measured using observation data from the first Incremental Isometric Exercise Test (IIET) delivered from month 3 to month 5 3. Fidelity of the isometric exercise prescription defined by participant heart rate data within HR reference intervals at Day 7-10 4. Short and medium-term adherence rates recorded as those adhering to isometric exercise intervention at week 4, month 3 and month 6 5. Recruitment and attrition rates from data collected at sites at month 10 and month 15 6. GPs and healthcare professionals’ attitudes to isometric exercise as a treatment option for patients, measured using remote focus groups and telephone interviews at month 11/12 7. Cost and cost-utility of the isometric exercise intervention using healthcare resource use data and quality-adjusted life years (QALYs) at month 15 (or last patient follow up) 8. Participant experiences of undertaking isometric exercise using participant isometric exercise experience surveys at week 4 9. Feasibility of isometric exercise intervention and study assessed using qualitative data from participants at month 7 and 11 of the study 10. Effect of COVID-19 on recruitment rates and participation using participant focus groups or telephone calls at month 7 and 11 of the study 11. Feasibility of using observed home blood pressure readings for remote blood pressure monitoring, using participant blood pressure data and observations from the measures at day 1, week 4, month 3 and month 6 Previous secondary outcome measures: 1. Fidelity of the isometric exercise prescription measured using prescription competency assessment data at month 3 2. Fidelity of the isometric exercise prescription measured using observation data from the first Incremental Isometric Exercise Test (IIET) delivered from month | — |
Countries
England, United Kingdom
Contacts
Public ContactEllie Santer
Outcome results
None listed