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Studies

Interventional Recruiting

NCT06952348 on ClinicalTrials.gov

HYPERtension Reduction Through WALKing Stairs Versus Brisk Walking

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

  • Sponsor: Karolinska Institute
  • Collaborators: Södersjukhuset (Stockholm South General Hospital), Ersta Cardiology Outpatient Clinic, Liljeholmens vårdcentral, Boo vårdcentral, Karolinska University Hospital, Sodertalje Hospital
  • Enrollment: 450 (Estimated)
  • Study start: 2025-11-27 (Actual)
  • Primary completion: 2028-12-01 (Estimated)
  • Study completion: 2029-05-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Double (Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Metabolic Disease
  • Cardiovascular Diseases
  • Hypertension
  • Obesity and Overweight

Intervention / Treatment

  • Behavioral: Stair and brisk walking combined
  • Behavioral: Brisk walking
  • Behavioral: Standard care

Primary Outcome Measures

  • Systolic Blood Pressure (SBP) at 6 months (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.

Countries

Sweden

Locations and Investigators

  • Karolinska Universitetssjukhuset Huddinge, Stockholm, Sweden (Not yet recruiting)
    • Helena Wallin
  • Liljeholmen Primary Care Center, Stockholm, Sweden (Recruiting)
    • Anna Ugarph-Morawski, MD, PhD
  • Södersjukhuset, Stockholm, Sweden (Not yet recruiting)
    • Raffaele Scorza
  • Södertälje sjukhus, Stockholm, Sweden (Not yet recruiting)