A Nurse Led Intervention to Promote Physical Activity

Not Applicable

Completed

• Conditions: Sedentary Behavior; Cardiovascular Risk Factor
• Interventions: Other: Nurse led tutorial on lifestyle management and pedometer hand-out; Other: Steps goal setting and supporting phone calls

• Registration Number: NCT04235647
• Lead Sponsor: National Institute of Cardiology, Warsaw, Poland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-10-01
• Status Verified: 2020-01
• Study Completion: 2020-01-01
• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-01-16
• Last Update Submitted: 2020-01-16
• Study First Posted: 2020-01-22
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Nurse led tutorial on lifestyle management and pedometer hand-out	Older, sedentary adults (age 50-75 years) with and least one other cardiovascular risk-factor
Control group	Nurse led tutorial on lifestyle management and pedometer hand-out	Older, sedentary adults (age 50-75 years) with and least one other cardiovascular risk-factor
Study group	Steps goal setting and supporting phone calls	Older, sedentary adults (age 50-75 years) with and least one other cardiovascular risk-factor

Primary Outcome Measures

Name	Time	Method
Change in total body weight	3 months

Secondary Outcome Measures

Name	Time	Method
Change in total cholesterol concentration at fasting	3 months
Change in glucose concentration at fasting	3 months
Change in resting blood pressure	3 months
Change in body mass index (BMI)	3 months
Change in waist circumference	3 months
Change in resting heart rate	3 months

Trial Locations

Locations (1)

NZOZ Arnika; 🇵🇱 Stare Babice, Ul. Rynek 10, Poland