Feasibility Study to Assess the Delivery of a Novel Isometric Exercise Intervention for People With Stage 1 Hypertension in the NHS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 11
- 主要终点
- Experience of intervention delivery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or over
- •Clinic systolic BP 140-159 mmHg
- •Able to provide informed consent
排除标准
- •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
结局指标
主要结局
Experience of intervention delivery
时间窗: 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.
Change in systolic blood pressure (mmHg) from baseline to Month 6.
时间窗: Participant 6 months
Change in systolic blood pressure (mmHg) from baseline to Week 4.
时间窗: Participant week 4
Change in systolic blood pressure (mmHg) from baseline to Month 3.
时间窗: Participant 3 months
次要结局
- Healthcare resource utilisation (f).(Participant 6 months.)
- Medication at long-term time point (b)(Participant 6 months.)
- Mid-term attrition rates from data collected at sites.(Participant 3 months)
- Medication at short-term time point (a)(Participant 4 weeks.)
- Healthcare resource utilisation (e).(Participant 6 months.)
- Short-term fidelity of the isometric exercise prescription.(Participant week 4)
- Short-term adherence to the Isometric exercise (IE) training.(Participant week 4)
- Long-term attrition rates from data collected at sites.(Participant 6 months)
- Healthcare resource utilisation (a).(Participant 6 months)
- Intervention costs(Participant 6 months.)
- Medication at long-term time point (a)(Participant 6 months.)
- Early fidelity of the isometric exercise prescription.(Participant week 1)
- Mid-term adherence to the Isometric exercise training.(Participant 3 Months)
- Long-term adherence to the Isometric exercise training.(Participant 6 Months)
- Recruitment rates from data collected at sites.(Project month 10)
- 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)
- Participant experiences of undertaking isometric exercise.(Participant week 4.)
- Healthcare resource utilisation (c).(Participant 6 months.)
- Short-term attrition rates from data collected at sites.(Participant week 4)
- 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.)
- Short-term Quality-adjusted life years (QALYs) calculated from patients' responses to the EQ-5D-5L questionnaire.(Participant 4 weeks)
- Mid-term Quality-adjusted life years calculated from patients' responses to the EQ-5D-5L questionnaire.(Participant 3 months)
- Long-term Quality-adjusted life years calculated from patients' responses to the EQ-5D-5L questionnaire.(Participant 6 months)
- Healthcare resource utilisation (b).(Participant 6 months.)
- Healthcare resource utilisation (d).(Participant 6 months.)
- Medication at short-term time point (b)(Participant 4 weeks.)
- Intervention costs.(Participant 3 months.)
- Medication at mid-term time point (a)(Participant 3 months.)
- Medication at mid-term time point (b)(Participant 3 months.)