Clinical trial NCT04235647: A Nurse Led Intervention to Promote Physical Activity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Cardiovascular Risk Factor
Keywords: sedentary
older adults
risk factor
intervention
pedometer
clinical trial
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
Collaborators: name: Józef Piłsudski University of Physical Education
First posted: 2020-01-22
Enrollment: 199
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in total body weight
timeFrame: 3 months
Secondary outcomes:
measure: Change in body mass index (BMI)
timeFrame: 3 months
measure: Change in waist circumference
timeFrame: 3 months
measure: Change in resting heart rate
timeFrame: 3 months
measure: Change in resting blood pressure
timeFrame: 3 months
measure: Change in total cholesterol concentration at fasting
timeFrame: 3 months
measure: Change in glucose concentration at fasting
timeFrame: 3 months
Other outcomes:
Locations:
city: Stare Babice
country: Poland
facility: NZOZ Arnika
state: Ul. Rynek 10
Study officials:
affiliation: Institute of Cardiology in Warsaw
name: Łukasz A. Małek, MD, PhD
role: STUDY_CHAIR
References: