A Nurse Led Intervention to Promote Physical Activity

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Sedentary Behavior, Cardiovascular Risk Factor

Intervention / Treatment
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* Other: Nurse led tutorial on lifestyle management and pedometer hand-out
* Other: Steps goal setting and supporting phone calls


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>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<br>* Individual 10-minute nurse-led tutorial with distributed handouts on the health benefits of regular physical activity and pedometer hand-out<br>Other: Steps goal setting and supporting phone calls<br>* A goal of minimum 7000 steps per day, phone calls to assess the goal meeting and to support goal achievement every 2 weeks<br>|
| Active Comparator: Control group<br>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<br>* Individual 10-minute nurse-led tutorial with distributed handouts on the health benefits of regular physical activity and pedometer hand-out<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total body weight |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedentary, older adults, risk factor, intervention, pedometer, clinical trial