Feasibility and Acceptability of Remote Home-Based Isometric Exercise and Lifestyle Change for the Management of Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Acceptability of Intervention
研究概览
简要总结
High blood pressure (hypertension) is a leading risk factor for cardiovascular diseases and may contribute to poor health and premature death. The purpose of this research is to learn if a home-based isometric exercise programme combined with lifestyle change advice is a practical and acceptable method for people diagnosed with hypertension to manage their condition. Isometric exercise involves a muscle contraction without movement of the limbs and previous research has shown this may be effective for reducing blood pressure. Therefore, this study will explore the experiences, thoughts, attitudes, and barriers to participation. It will also examine the effect the isometric exercise has on blood pressure.
Participants will undertake an isometric exercise programme using a wall squat position, 3 times per week, for 12 weeks. The exercise sessions will be completed at home with remote online supervision by an exercise professional. Lifestyle change advice will given in line with current guidelines to promote healthy behaviours to reduce high blood pressure. After 12 weeks, participants will be encouraged to continue with the wall squat exercise for a further 12-weeks unsupervised. Throughout the study, participants' blood pressure and daily activity will be recorded using a smartwatch device.
Upon completion of the study, participants will be interviewed to gather their views and opinions on the programme. Changes in blood pressure will be evaluated at 12 and 24 weeks.
By exploring whether lifestyle advice and an isometric exercise programme is a feasible and acceptable method for hypertensive people to manage their condition and how this influences blood pressure, this research may aid in the development of a strategy to manage hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Diagnosis of Arterial Hypertension (AH) in accordance with NICE guidelines.
- •Under pharmacological treatment for AH with antihypertensive drug, type and dose maintained for the previous four months.
- •Blood Pressure with values <180 and <110 mmHg for office systolic and diastolic BP, respectively.
- •Not currently engaged in any structured or supervised exercise training programme, including resistance, aerobic, or isometric exercise, defined as planned exercise performed ≥2 times per week at moderate or greater intensity, for at least three months prior to enrolment. Participants may engage in habitual physical activity; however, those meeting current physical activity recommendations (≥150 min·week-¹ of moderate-intensity or ≥75 min·week-¹ of vigorous-intensity activity, or an equivalent combination) will be excluded. Physical activity levels will be ascertained using the International Physical Activity Questionnaire (IPAQ).
- •Written informed consent provided.
排除标准
- •Body mass index >35 kg/m
- •Presence of cardiovascular disease beyond hypertension.
- •Known orthopaedic, musculoskeletal, or neurological conditions that restrain isometric exercise execution.
- •Presence of secondary hypertension
- •Inability to follow verbal instructions or complete study protocol
研究组 & 干预措施
Home Based Isometric Exercise and Lifestyle Change Group
Participants randomised to this group will undertake a remotely supervised 12-week home-based isometric exercise training intervention 3 times per week. The bilateral leg isometric exercise consists of 5-stage wall squat position determined by individual calculations at baseline. Rate of perceived exertion (RPE) will be monitored throughout the intervention and used to guide the squat stage position. Lifestyle change advice will be given in accordance with NICE guidelines for hypertension. Participants will receive a smartwatch (Huawei D2) to monitor their daily physical activity (step count) and record their home blood pressure.
干预措施: Isometric Exercise and Lifestyle Change Advice (Behavioral)
Lifestyle Change Control Group
Participants randomised to this group will not receive any intervention other than lifestyle change advice in accordance with NICE guidelines for hypertension. Participants will receive a smartwatch (Huawei D2) to monitor their daily physical activity (step count) and record their home blood pressure.
干预措施: Lifestyle Change Advice (Behavioral)
结局指标
主要结局
Acceptability of Intervention
时间窗: Post 24 weeks
Participant acceptability will be determined through a qualitative process evaluation involving semi-structured interviews. The interviews will explore experience with study participation (informed consent process, time commitment), the acceptability of measures (readability, burden), and experiences, thoughts, and attitudes toward current usual care.
Feasibility of Intervention
时间窗: Baseline to 24 weeks
Feasibility will be determined by the rate of screening, eligibility, recruitment, and retention at 12 and 24 weeks.
次要结局
- Office and Ambulatory Blood Pressure(Baseline to 24 weeks.)