A Nurse Led Intervention to Promote Physical Activity (STEP-IT-UP)

National Institute of Cardiology, Warsaw, Poland

Status: Completed

Conditions: Cardiovascular Risk Factor; Sedentary Behavior

Treatments: Other: Nurse led tutorial on lifestyle management and pedometer hand-out; Other: Steps goal setting and supporting phone calls

Study type: Interventional

Funder types: Other

Identifiers

NCT04235647

DM-72

Details and patient eligibility

About

Regular physical activity should be the essence of treatment in patients with cardiovascular risk factors. Unfortunately, these interventions are usually insufficiently promoted and therefore have only limited efficacy. The aim of the study was to determine the benefits of nurse led intervention to promote physical activity in sedentary older adults with cardio-vascular risk factors in the outpatient setting. Eligible patients are randomized in a 1:1 fashion to receive nurse led tutorial on life-style modification including pedometer hand-out with a daily goal of at least 7000 steps and supporting phone calls (study group) or without a goal or calls (control group). The primary end-point of the study is change in body weight. Secondary end-points include changes in resting heart rate, systolic and diastolic blood pressure, total cholesterol and fasting glucose and clinical outcomes at 3 months follow-up.

Enrollment: 199 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• sedentary lifestyle defined as mean walking distance per day of no more than 3 km as reported by the patients;
• history of at least one of the following conditions: obesity (defined as body mass index ≥30 for I st degree obesity, ≥35 for second degree obesity and ≥40 for third degree obesity), hypertension, diabetes mellitus, dyslipidemia, stable coronary artery disease with or without prior myocardial infarction, peripheral arterial disease, stable arrhythmias, heart failure and/or prior stroke.

Exclusion criteria

• unstable clinical condition (in the form of unstable coronary artery disease or peripheral arterial disease, unstable heart failure or unstable arrhythmias);
• inability to undertake physical activity due to orthopedic reasons or other disabilities;
• planned changes in pharmacological treatment during the study period;
• lack of will to participate in the study and to sign the the written informed consent for the participation in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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199 participants in 2 patient groups

Study group

Experimental group

Description:

Older, sedentary adults (age 50-75 years) with and least one other cardiovascular risk-factor

Treatment:

Other: Nurse led tutorial on lifestyle management and pedometer hand-out

Other: Steps goal setting and supporting phone calls

Control group

Active Comparator group

Description:

Older, sedentary adults (age 50-75 years) with and least one other cardiovascular risk-factor

Treatment:

Other: Nurse led tutorial on lifestyle management and pedometer hand-out