Stage 1 and 2 hypertension Circulatory System
Conditions
Interventions
This study is a multi-centre randomised controlled trial (RCT) of an isometric exercise intervention for participants with Stage 1 and Stage 2 hypertension. The design follows an effectiveness-impleme
Sponsors
East Kent Hospitals University NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Participants with Stage 1 or 2 Hypertension who have uncomplicated hypertension and may be on a single anti-hypertensive agent who are: 1. Aged 18+ years old 2. Stage 1 or 2 hypertension (=140/90 -179/119 mmHg) that has been diagnosed by a health care professional and confirmed by a GP 3. Able to undertake an IE intervention 4. Able to self-monitor BP 5. Prescribed no more than 1 anti-hypertensive agent
Exclusion criteria
Exclusion criteria: 1. Alteration to antihypertensive medications (either dose or number of medications) within 6 weeks prior to screening 2. Receiving a ß-blocker 3. Averaged home SBP <120 mmHg following 3 days screening 4. Ischaemic heart disease, stroke or transient ischaemic attack in the past 3 months 5. Moderate or severe valvular heart disease, atrial or ventricular arrhythmia, congenital or inherited heart condition 6. Pregnancy or actively trying to conceive 7. Enrolled in CTIMP/device/another interventional study of BP. 8. Any condition that would be made worse by doing the wall squat exercise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average home systolic blood pressure (SBP) measured using a home BP monitor, change from baseline to 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants with home average BP of =135/85 mmHg measured using a home BP monitor at 4 weeks, 3 months, 6 months and 12 months. 2. Average Home Systolic blood pressure measured using a home BP monitor, change from baseline to 4 weeks. 3. Average Home Systolic blood pressure measured using a home BP monitor, change from baseline to 6 months. 4. Average Home Systolic blood pressure measured using a home BP monitor, change from baseline to 12 months in the IE group. 5. Average Home Diastolic blood pressure measured using a home BP monitor, change from baseline to 4 weeks. 6. Average Home Diastolic blood pressure measured using a home BP monitor, change from baseline to 3 months. 7. Average Home Diastolic blood pressure measured using a home BP monitor, change from baseline to 6 months. 8. Average Home Diastolic blood pressure measured using a home BP monitor, change from baseline to 12 months in the IE group. 9. Fidelity of intervention using the number of perceived exertion scores within the range 7-9 during the last exercise bouts collected using participant-reported data in the first week of intervention in the first 50 IE participants. 10. Participant experience (acceptability, adoption and feasibility) of intervention measured using an IE experience questionnaire, considering barriers and facilitators using focus groups at 4 weeks. 11. Change from baseline in the use and cost of NHS services by participants in both groups, measured using the Health Resources Utilisation Questionnaire at 3 months and 6 months. 12. Change from baseline in Quality of Life in both groups measured using the EQ-5D-5L questionnaire at 3 months and 6 months. 13. Total of equipment, supplies and staff costs measured using internal cost records and staff time and hourly rate records as total cost of the intervention, using costing analysis throughout the study. 14. Total of equipment, supplies and staff costs divided by the number of participants measured using in | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactEllie Santer
Outcome results
None listed