HYPERtension Reduction Through WALKing Stairs Versus Brisk Walking

Официальное название

HYPERtension Reduction Through WALKing Stairs Versus Brisk Walking in Individuals With Increased Cardiometabolic Risk - The HYPERWALK Randomized Controlled Trial

Обзор

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.

Вмешательства

• Поведенческое Stair and brisk walking combined
  See arms.
• Поведенческое Brisk walking
  See arms.
• Поведенческое Standard care
  See arms.

Первичные конечные точки

• Systolic Blood Pressure (SBP) at 6 months [Срок оценки: 6 months]

Вторичные конечные точки (5)

• Diastolic Blood Pressure (DBP) [Срок оценки: 6 months]
• HOMA-index [Срок оценки: 6 months]
• HbA1c [Срок оценки: 6 months]
• LDL cholesterol [Срок оценки: 6 months]
• Triglycerides [Срок оценки: 6 months]

Критерии участия

Критерии включения

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 40.
• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Швеция · 4 центра

• Karolinska Universitetssjukhuset Huddinge — Stockholm
• Liljeholmen Primary Care Center — Stockholm
• Södersjukhuset — Stockholm
• Södertälje sjukhus — Stockholm

Идентификаторы

NCT: NCT06952348 · 2024-05912-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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