A Nurse Led Intervention to Promote Physical Activity

Cardiovascular Risk Factor Clinical Trial

— STEP-IT-UP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04235647
• Other study ID #: DM-72
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2020
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: January 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Sedentary Behavior

Intervention

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
• 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

Locations

Country	Name	City	State
Poland	NZOZ Arnika	Stare Babice	Ul. Rynek 10

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland	Józef Pilsudski University of Physical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total body weight		3 months
Secondary	Change in body mass index (BMI)		3 months
Secondary	Change in waist circumference		3 months
Secondary	Change in resting heart rate		3 months
Secondary	Change in resting blood pressure		3 months
Secondary	Change in total cholesterol concentration at fasting		3 months
Secondary	Change in glucose concentration at fasting		3 months