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NCT Number: NCT06952348

HYPERtension Reduction Through WALKing Stairs Versus Brisk Walking

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.

Recruiting

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Universitetssjukhuset Huddinge, Stockholm, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Stair and brisk walking combined

Behavioral

See arms.

Brisk walking

Behavioral

See arms.

Standard Care

Behavioral

See arms.

Primary outcomes

  1. Systolic Blood Pressure (SBP) at 6 months

    Time frame: 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.

Secondary outcomes

  1. Diastolic Blood Pressure (DBP)

    Time frame: 6 months

    Office diastolic blood pressure (DBP) at 6-month follow-up, adjusted for baseline values. DBP is a clinically relevant indicator of cardiovascular risk and contributes to the assessment of overall blood pressure control.

  2. HOMA-index

    Time frame: 6 months

    Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 6-month follow-up, adjusted for baseline values. HOMA-IR is a validated surrogate marker of insulin resistance and metabolic risk, commonly used in cardiometabolic research.

  3. HbA1c

    Time frame: 6 months

    Hemoglobin A1c (HbA1c) at 6-month follow-up, adjusted for baseline values. HbA1c reflects average blood glucose levels over the preceding 2-3 months and is a standard marker for assessing glycemic control and diabetes risk.

  4. LDL cholesterol

    Time frame: 6 months

    Low-Density Lipoprotein (LDL) cholesterol at 6-month follow-up, adjusted for baseline values. LDL cholesterol is a key biomarker for cardiovascular risk and a primary target in lipid-lowering therapies.

  5. Triglycerides

    Time frame: 6 months

    Triglycerides (TG) at 6-month follow-up, adjusted for baseline levels. Elevated TG are associated with increased cardiovascular risk and are a core component of the metabolic syndrome.

Study contacts

Contact information is provided by the study sponsor or research team.

Carl Johan Sundberg

CONTACT

[email protected]

0046852480000

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Boo vårdcentral
  • Ersta Cardiology Outpatient Clinic
  • Karolinska University Hospital
  • Liljeholmens vårdcentral
  • Sodertalje Hospital
  • Stockholm South General Hospital

Registry information

Official study title

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

Acronym: HYPERWALK

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Apr 30, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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