Metabolic DiseaseHYPERWALKNCT06952348
HYPERtension Reduction Through WALKing Stairs Versus Brisk Walking
A study testing Stair and brisk walking combined and Brisk walking in people with Metabolic Disease and Cardiovascular Diseases, run by Karolinska Institutet at 4 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Metabolic Disease, Cardiovascular Diseases, Hypertension
- What is being tested?
- Stair and brisk walking combined and Brisk walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 4 sitesSweden
- Study dates
- 27 Nov 2025to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden4 sites, 4 recruiting
- Not yet recruiting
Karolinska Universitetssjukhuset Huddinge
Stockholm
Helena Wallin, 0046812380000, helena.wallin@ki.se
- Recruiting
Liljeholmen Primary Care Center
Stockholm
Anna Ugarph-Morawski, MD, PhD, 0704872194 ext. +47812367900, anna.ugarph-morawski@regionstockholm.se
- Not yet recruiting
Södersjukhuset
Stockholm
Raffaele Scorza, 0046812361000, raffaele.scorza@ki.se
- Not yet recruiting
Södertälje sjukhus
Stockholm
Giulia Ferrannini, 0046812324000, giulia.ferrannini@ki.se
About this study
Official title: 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.
Read more
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.
- Being tested
- Stair and brisk walking combined, Brisk walking, Standard care
- Keywords
- Cardiovascular prevention, Physical activity, Smart medicine, Obesity, Overweight, Hypertension
- Medical subject headings
- Metabolic Diseases, Cardiovascular Diseases, Hypertension, Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stair and brisk walking combinedBehavioural
See arms.
Brisk walkingBehavioural
See arms.
Standard careBehavioural
See arms.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start27 Nov 2025
- Primary completionDec 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm South General Hospital, Ersta Cardiology Outpatient Clinic, Liljeholmens vårdcentral, Boo vårdcentral, Karolinska University Hospital, Sodertalje Hospital
- Responsible party
- Principal investigator, Pontus Andell, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952348
- Sponsor's protocol ID
- 2024-05912-01
- Acronym
- HYPERWALK
- Status last verified
- Dec 2025
- First submitted
- 23 Apr 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Blood pressure (systolic and diastolic), BMI, sex, age, HOMA-index, HbA1c, Triglycerides, LDL will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYPERtension Reduction Through WALKing Stairs Versus Brisk Walking in Individuals With Increased Cardiometabolic Risk - The HYPERWALK Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06952348
- Acronym / sponsor ID
- HYPERWALK / 2024-05912-01
- Keywords
- Cardiovascular prevention, Physical activity, Smart medicine, Obesity, Overweight, Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Stockholm South General Hospital, Ersta Cardiology Outpatient Clinic, Liljeholmens vårdcentral, Boo vårdcentral, Karolinska University Hospital, Sodertalje Hospital
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stair and brisk walking combined | Experimental | Behavioral: Stair and brisk walking combinedParticipants 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. |
| Brisk walking | Experimental | Behavioral: Brisk walkingParticipants will double their baseline physical activity levels by engaging in brisk walking only, with a minimum target of >150 minutes per week. |
| Standard care | Active comparator | Behavioral: Standard careParticipants 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stair and brisk walking combinedSee arms. | Behavioural | Stair and brisk walking combined |
| Brisk walkingSee arms. | Behavioural | Brisk walking |
| Standard careSee arms. | Behavioural | Standard care |
Primary outcome
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.
5 secondary outcomes
Diastolic Blood Pressure (DBP)
Time frame: 6 months
HOMA-index
Time frame: 6 months
HbA1c
Time frame: 6 months
LDL cholesterol
Time frame: 6 months
Triglycerides
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Yes. Blood pressure (systolic and diastolic), BMI, sex, age, HOMA-index, HbA1c, Triglycerides, LDL will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stair and brisk walking combined and Brisk walking in people with Metabolic Disease and Cardiovascular Diseases, run by Karolinska Institutet at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carl Johan Sundberg (0046852480000, carl.j.sundberg@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (SBP) at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.