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| Name | Class |
|---|---|
| Stockholm South General Hospital | OTHER |
| Ersta Cardiology Outpatient Clinic | UNKNOWN |
| Liljeholmens vårdcentral | UNKNOWN |
| Boo vårdcentral |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stair and brisk walking combined | Behavioral | See arms. |
| |
| 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 |
| 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 |
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Inclusion Criteria
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:
Exclusion Criteria
Medical contraindications to physical activity (based on FYSS 2021, p. 182):
Other exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carl Johan Sundberg | Contact | 0046852480000 | carl.j.sundberg@ki.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Universitetssjukhuset Huddinge | Not yet recruiting | Stockholm | Sweden |
Blood pressure (systolic and diastolic), BMI, sex, age, HOMA-index, HbA1c, Triglycerides, LDL will be shared.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 13, 2025 | Oct 13, 2025 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D002318 | Cardiovascular Diseases |
| D006973 | Hypertension |
| D009765 | Obesity |
| D050177 | Overweight |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| UNKNOWN |
| Karolinska University Hospital | OTHER |
| Sodertalje Hospital | OTHER |
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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.
| Brisk walking |
| Behavioral |
See arms. |
|
| Standard care | Behavioral | See arms. |
|
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 |
| Liljeholmen Primary Care Center | Recruiting | Stockholm | Sweden |
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| Södersjukhuset | Not yet recruiting | Stockholm | Sweden |
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| Södertälje sjukhus | Not yet recruiting | Stockholm | Sweden |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |