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A Nurse Led Intervention to Promote Physical Activity

NCT04235647 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2020-01-22

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Józef Piłsudski University of Physical Education

    collaborator OTHER

  • National Institute of Cardiology, Warsaw, Poland

    lead OTHER

Principal Investigators

  • Łukasz A. Małek, MD, PhD · Institute of Cardiology in Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-10-01
Completion
2020-01-01

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04235647 on ClinicalTrials.gov