A Nurse Led Intervention to Promote Physical Activity

NCT ID: NCT04235647

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2020-01-01

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.

Conditions

Sedentary Behavior; Cardiovascular Risk Factor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study group

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

Group Type: EXPERIMENTAL

Nurse led tutorial on lifestyle management and pedometer hand-out

Intervention Type: OTHER

Individual 10-minute nurse-led tutorial with distributed handouts on the health benefits of regular physical activity and pedometer hand-out

Steps goal setting and supporting phone calls

Intervention Type: OTHER

A goal of minimum 7000 steps per day, phone calls to assess the goal meeting and to support goal achievement every 2 weeks

Control group

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

Group Type: ACTIVE_COMPARATOR

Nurse led tutorial on lifestyle management and pedometer hand-out

Intervention Type: OTHER

Individual 10-minute nurse-led tutorial with distributed handouts on the health benefits of regular physical activity and pedometer hand-out

Interventions

Nurse led tutorial on lifestyle management and pedometer hand-out

Individual 10-minute nurse-led tutorial with distributed handouts on the health benefits of regular physical activity and pedometer hand-out

Intervention Type: OTHER

Steps goal setting and supporting phone calls

A goal of minimum 7000 steps per day, phone calls to assess the goal meeting and to support goal achievement every 2 weeks

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Józef Piłsudski University of Physical Education

OTHER

Sponsor Role: collaborator

National Institute of Cardiology, Warsaw, Poland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Łukasz A. Małek, MD, PhD

Role: STUDY_CHAIR

Institute of Cardiology in Warsaw

Locations

NZOZ Arnika

Stare Babice, Ul. Rynek 10, Poland

Countries

Poland

Other Identifiers

DM-72

Identifier Type: -

Identifier Source: org_study_id