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

Sponsor

Institute of Cardiology, Warsaw, Poland (Other)

Overall Status

Completed

CT.gov ID

NCT04235647

Collaborator

Józef Piłsudski University of Physical Education (Other)

199

Enrollment

Location

Arms

Actual Duration (Months)

13.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sedentary Behavior Cardiovascular Risk Factor	Other: Nurse led tutorial on lifestyle management and pedometer hand-out Other: Steps goal setting and supporting phone calls	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

199 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Oct 1, 2019

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in total body weight [3 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.