HYPERtension Reduction Through WALKing Stairs Versus Brisk Walking

NCT06952348 | Recruiting

• 1 other identifier: 2024-05912-01
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 4

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

Obesity and Overweight; Metabolic Disease; Cardiovascular Diseases; Hypertension

Keywords

Cardiovascular prevention; Physical activity; Smart medicine; Obesity; Overweight; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Diastolic Blood Pressure (DBP)

  6 months

• HOMA-index

  6 months

• HbA1c

  6 months

• LDL cholesterol

  6 months

• Triglycerides

  6 months

Study Arms (3)

Stair and brisk walking combined

EXPERIMENTAL

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

Brisk walking

EXPERIMENTAL

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

Standard care

ACTIVE COMPARATOR

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

Interventions

Stair and brisk walking combined BEHAVIORAL

See arms.

Stair and brisk walking combined

Brisk walking BEHAVIORAL

See arms.

Brisk walking

Standard care BEHAVIORAL

See arms.

Standard care

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

Study Sites (4)

Karolinska Universitetssjukhuset Huddinge

Stockholm, Sweden

NOT YET RECRUITING

Liljeholmen Primary Care Center

Stockholm, Sweden

RECRUITING

Södersjukhuset

Stockholm, Sweden

NOT YET RECRUITING

Södertälje sjukhus

Stockholm, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Metabolic Diseases; Cardiovascular Diseases; Hypertension; Obesity; Overweight; Motor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Vascular Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Carl Johan Sundberg

CONTACT

0046852480000; carl.j.sundberg@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Consultant in Cardiology

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: November 27, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

SE (4)