Metabolic Disease, Cardiovascular Diseases, Hypertension, Obesity and Overweight
Conditions
Keywords
Cardiovascular prevention, Physical activity, Smart medicine, Obesity, Overweight, Hypertension
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.
Interventions
BEHAVIORALStair and brisk walking combined
See arms.
BEHAVIORALBrisk walking
See arms.
BEHAVIORALStandard care
See arms.
Sponsors
Södersjukhuset (Stockholm South General Hospital)
Ersta Cardiology Outpatient Clinic
Liljeholmens vårdcentral
Boo vårdcentral
Karolinska University Hospital
Sodertalje Hospital
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Blood Pressure (DBP) | 6 months | 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. |
| HOMA-index | 6 months | 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. |
| HbA1c | 6 months | 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. |
| LDL cholesterol | 6 months | 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. |
| Triglycerides | 6 months | 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. |
Countries
Sweden
Contacts
Primary ContactCarl Johan Sundberg
Outcome results
None listed