HYPERtension Reduction Through WALKing Stairs Versus Brisk Walking (HYPERWALK)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Hypertension; Metabolic Disease; Obesity and Overweight
• Intervention / Treatment: Behavioral: Stair and brisk walking combined; Behavioral: Brisk walking; Behavioral: Standard care

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carl Johan Sundberg; Phone Number: 0046852480000; Email: carl.j.sundberg@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Not yet recruiting
    • Södersjukhuset
    • Contact: Raffaele Scorza; Phone Number: 0046812361000; Email: raffaele.scorza@ki.se
  • Stockholm, Sweden
    • Not yet recruiting
    • Karolinska Universitetssjukhuset Huddinge
    • Contact: Helena Wallin; Phone Number: 0046812380000; Email: helena.wallin@ki.se
  • Stockholm, Sweden
    • Recruiting
    • Liljeholmen Primary Care Center
    • Contact: Anna Ugarph-Morawski, MD, PhD; Phone Number: +47812367900 0704872194; Email: anna.ugarph-morawski@regionstockholm.se
  • Stockholm, Sweden
    • Not yet recruiting
    • Södertälje Sjukhus
    • Contact: Giulia Ferrannini; Phone Number: 0046812324000; Email: giulia.ferrannini@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

Men and women aged 35 years or older with increased cardiometabolic risk, defined by all of the following:

1. Clinically confirmed hypertension, with or without antihypertensive treatment, as documented in the Electronic Health Record (EHR).
2. Overweight or obesity, defined as BMI between 27 and 40.

3. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Stair and brisk walking combined; See arms.
Experimental: 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.	Behavioral: Brisk walking; See arms.
Active Comparator: 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.	Behavioral: Standard care; See arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure (SBP) at 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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic Blood Pressure (DBP)	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.	6 months
HOMA-index	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.	6 months
HbA1c	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.	6 months
LDL cholesterol	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.	6 months
Triglycerides	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.	6 months

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital; Sodertalje Hospital; Södersjukhuset (Stockholm South General Hospital); Ersta Cardiology Outpatient Clinic; Liljeholmens vårdcentral; Boo vårdcentral

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: April 23, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Hypertension; Overweight; Physical activity; Cardiovascular prevention; Smart medicine
• Additional Relevant MeSH Terms: Vascular Diseases; Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Hypertension; Cardiovascular Diseases; Metabolic Diseases; Motor Activity; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2024-05912-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Blood pressure (systolic and diastolic), BMI, sex, age, HOMA-index, HbA1c, Triglycerides, LDL will be shared.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No