Skip to main content
Clinical Trials/NCT04235647
NCT04235647
Completed
N/A

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

National Institute of Cardiology, Warsaw, Poland1 site in 1 country199 target enrollmentOctober 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sedentary Behavior
Sponsor
National Institute of Cardiology, Warsaw, Poland
Enrollment
199
Locations
1
Primary Endpoint
Change in total body weight
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
January 1, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Institute of Cardiology, Warsaw, Poland
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Change in total body weight

Time Frame: 3 months

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials