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

A Nurse Led Intervention to Promote Physical Activity in Sedentary Older Adults With Cardio-vascular Risk Factors in the Outpatient Setting - a Randomized Controlled Trial

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Ul. Rynek 10
    • Stare Babice, Ul. Rynek 10, Poland, 05-082
      • NZOZ Arnika

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Study group; Older, sedentary adults (age 50-75 years) with and least one other cardiovascular risk-factor	Other: 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; 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
ACTIVE_COMPARATOR: Control group; Older, sedentary adults (age 50-75 years) with and least one other cardiovascular risk-factor	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in total body weight	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Cardiology, Warsaw, Poland
• Collaborators: Józef Piłsudski University of Physical Education
• Investigators: Study Chair: Łukasz A. Małek, MD, PhD, Institute of Cardiology in Warsaw

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): October 1, 2019
• Study Completion (ACTUAL): January 1, 2020

Study Registration Dates

• First Submitted: January 10, 2020
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (ACTUAL): January 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 16, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: older adults; clinical trial; intervention; sedentary; risk factor; pedometer
• Other Study ID Numbers: DM-72

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No