Acute Blood Pressure Responses to Isometric Wall Squat Exercise in Adults With Hypertension and CPAP-Treated Obstructive Sleep Apnea: A Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 12-hour systolic blood pressure
研究概览
简要总结
This study will look at whether a simple exercise called the isometric wall squat can help lower blood pressure in adults who have both hypertension and obstructive sleep apnoea treated with CPAP. Obstructive sleep apnoea is a condition in which breathing repeatedly stops or becomes shallow during sleep, and it is closely linked to high blood pressure. Although CPAP helps treat sleep apnoea, it usually lowers blood pressure only a little, so additional non-drug strategies may be useful.
The study will compare two situations in the same participants: one session of wall squat exercise and one non-exercise control session. Each participant will take part in both sessions, but the order will be random. This design helps the researchers compare blood pressure changes more fairly within the same person.
Participants will first attend a familiarization session, where the study procedures will be explained and the exercise intensity will be checked. After that, they will complete the two study sessions at home, during their usual CPAP treatment visits. The sessions will be separated by at least 48 hours and completed within one week. Both sessions will be scheduled at the same time of day to reduce the effect of normal daily changes in blood pressure.
The main result the researchers will measure is the average systolic blood pressure during the 12 hours after each session, using ambulatory blood pressure monitoring. This means blood pressure will be measured over time while the participant goes about normal daily activities. The researchers want to find out whether a single session of wall squat exercise produces a greater blood pressure reduction than simply resting without exercise.
This study may help improve understanding of whether isometric exercise can be a practical, low-cost, home-based option to support blood pressure control in people with hypertension and CPAP-treated obstructive sleep apnoea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old.
- •Diagnosis of hypertension and OSA confirmed by polysomnography or respiratory sleep study.
- •Apnea-Hypopnea Index (AHI) of at least 15 events per hour.
- •Treatment with CPAP for at least 3 months.
排除标准
- •Mean CPAP adherence <4 hours/night over the last month, documented by device download.
- •Heart failure.
- •Peripheral artery disease.
- •Atrial fibrillation.
- •Chronic obstructive pulmonary disease.
- •Chronic kidney disease.
- •History of acute coronary syndrome, stroke, or transient ischemic attack in the previous 12 months.
- •Relevant changes in antihypertensive or other cardiovascular pharmacotherapy in the previous 3 months.
- •Relevant changes in CPAP prescription in the previous 3 months.
- •Any contraindication to exercise according to contemporary ESC/ACSM recommendations (e.g. unstable angina).
- •Pregnancy or breastfeeding.
- •Neurological and/or orthopaedic conditions that could interfere with exercise (e.g. severe knee osteoarthritis, recent lower-limb surgery).
- •Inability to read, understand, or provide informed consent.
研究组 & 干预措施
Control
non-exercise control session plus standard drug therapy
Isometric Wall Squat
Isometric Wall Squat exercise session plus standard drug therapy
干预措施: Isometric Wall Squat (Other)
结局指标
主要结局
12-hour systolic blood pressure
时间窗: During the 12 hours following the exercise or control session
Systolic blood pressure measured by ambulatory blood pressure monitoring every 30 minutes for 12 hours after the exercise or control session
次要结局
- 12-hour diastolic blood pressure(During the 12 hours following the exercise or control session)
- Short-term blood pressure variability(During the 12 hours following the exercise or control session)
- Pulse pressure(During the 12 hours following the exercise or control session)
研究者
Fernando Ribeiro
Coordinator Professor with Habilitation
Aveiro University