Clinical trial NCT06952348: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Disease
Cardiovascular Diseases
Hypertension
Obesity and Overweight
Keywords: Cardiovascular prevention
Physical activity
Smart medicine
Obesity
Overweight
Hypertension
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Södersjukhuset (Stockholm South General Hospital)
name: Ersta Cardiology Outpatient Clinic
name: Liljeholmens vårdcentral
name: Boo vårdcentral
name: Karolinska University Hospital
name: Sodertalje Hospital
First posted: 2025-04-30
Enrollment: 450
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Systolic Blood Pressure (SBP) at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Diastolic Blood Pressure (DBP)
timeFrame: 6 months
measure: HOMA-index
timeFrame: 6 months
measure: HbA1c
timeFrame: 6 months
measure: LDL cholesterol
timeFrame: 6 months
measure: Triglycerides
timeFrame: 6 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Stockholm
country: Sweden
facility: Södertälje sjukhus
Study officials:
References: