HYPERtension Reduction Through WALKing Stairs Versus Brisk Walking in Individuals With Increased Cardiometabolic Risk - The HYPERWALK Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 4
- 主要终点
- Systolic Blood Pressure (SBP) at 6 months
研究概览
简要总结
This clinical trial investigates whether incorporating stair walking into daily routines improves physical health in adults at risk of lifestyle-related conditions such as hypertension, type 2 diabetes, and cardiovascular disease. Participants will be randomized into three groups: (1) stair walking combined with brisk walking, (2) brisk walking alone, and (3) a control group receiving standard lifestyle advice without specific exercise instructions, stratified by age (<65 y/o, v >=65) and site.
The primary objective is to assess whether the combination of stair and brisk walking leads to greater reductions in systolic blood pressure compared to brisk walking alone or standard care. Secondary outcomes include changes in cardiometabolic risk factors.
Participants in the stair walking group will be instructed to climb ≥250 steps per day (~5.5 minutes/day or ~37.5 minutes/week), or complete an equivalent elevation via inclined slopes, along with ≥75 minutes of brisk walking per week. Those in the brisk walking group will walk ≥150 minutes per week. The control group will receive general lifestyle advice but no tailored physical activity goals or feedback.
Participants in both active groups will aim to double their baseline activity levels. Physical activity will be continuously monitored using wearable devices. The active groups will receive personalized feedback and motivational support throughout the 6-month intervention period.
If effective, this study may offer a simple, scalable, and low-cost intervention model for use in clinical and public health settings, emphasizing personalized goals, remote monitoring, and behavioral support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Due to the nature of the intervention, participant blinding is not feasible. To ensure validity, group allocation will be disclosed only after baseline data collection and by personnel not involved in outcome assessments. To preserve assessor blinding at follow-up, participants will be instructed not to reveal their group assignment. Additionally, study staff will document whether blinding was maintained after each follow-up assessment.
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 35 years or older with increased cardiometabolic risk, defined by all of the following:
- •Clinically confirmed hypertension, with or without antihypertensive treatment, as documented in the Electronic Health Record (EHR).
- •Overweight or obesity, defined as BMI between 27 and
- •Physically inactive lifestyle, defined as either:
- •Light intensity or inactive category on the Stanford Brief Activity Survey (SBAS), or
- •Light intensity or inactive category in the physical activity section of the Swedish National Board of Health and Welfare Lifestyle Questionnaire.
排除标准
- •Medical contraindications to physical activity (based on FYSS 2021, p. 182):
- •Severe, symptomatic aortic stenosis
- •Acute pulmonary embolism, myocarditis, pericarditis, or systemic infection (e.g., fever, muscle pain, lymphadenopathy)
- •Suspected or known aortic dissection
- •Severe hypertension (Grade 3: SBP >180 mmHg or DBP >110 mmHg), regardless of symptoms
- •Unstable coronary artery disease (including unstable angina, suboptimally treated stable angina, or recent myocardial infarction <8 weeks)
- •Symptomatic, uncontrolled arrhythmia
- •Symptomatic, uncontrolled heart failure
- •Other exclusion criteria:
- •Implanted pacemaker or ICD
- •Pregnancy
- •Smartphone incompatibility with Fitrockr© app (iOS <16 or Android OS <10)
- •Inability to understand Swedish or English
- •Any condition that may interfere with protocol compliance (e.g., severe mental illness or cognitive impairment)
- •Inability to walk stairs
研究组 & 干预措施
Standard care
Participants will receive general lifestyle advice aligned with current physical activity guidelines but will not be provided with specific exercise instructions, personalized activity targets, or feedback. They will wear the same activity monitor as the intervention groups, but without access to feedback or goal-setting features.
干预措施: Standard care (Behavioral)
Stair and brisk walking combined
Participants will double their baseline physical activity levels by combining stair walking and brisk walking. The stair walking goal is ≥250 steps per day (equivalent to ~37.5-45 meters elevation or 15 floor levels), totaling ~37.5 minutes per week. In addition, they will complete ≥75 minutes of brisk walking per week.
干预措施: Stair and brisk walking combined (Behavioral)
Brisk walking
Participants will double their baseline physical activity levels by engaging in brisk walking only, with a minimum target of >150 minutes per week.
干预措施: Brisk walking (Behavioral)
结局指标
主要结局
Systolic Blood Pressure (SBP) at 6 months
时间窗: 6 months
Office systolic blood pressure (SBP) at 6-month follow-up, adjusted for baseline values. SBP is a validated and widely accepted surrogate marker for cardiovascular morbidity and mortality, as well as overall health risk.
次要结局
- Diastolic Blood Pressure (DBP)(6 months)
- HOMA-index(6 months)
- HbA1c(6 months)
- LDL cholesterol(6 months)
- Triglycerides(6 months)
研究者
Pontus Andell
Associate Professor, Consultant in Cardiology
Karolinska Institutet