Physical Exercise Prescription With PEdometeR in General Practice for Patients With Cardiovascular Risk Factors - PEPPER

Study Overview
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Brief Summary
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This study evaluates the efficacy, in terms of energy expenditure, physical activity level, quality of life, blood pressure, waist circumference and weight, of a general practice based intervention involving a personalised physical exercise medical prescription, the structured delivery of information on the benefits of physical activity, a pedometer, and a pedometer log book, in 35 to 74 year old patients with cardiovascular risks factors.

Detailed Description
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Background: Health benefits of physical activity have been shown to be at least as important as drug therapies in the prevention of cardiovascular diseases in patients with hypertension, hyperlipidaemia or diabetes. However, few strategies have demonstrated efficacy and practicality in the promotion of physical exercise among these high risk patients in general practice. The PEPPER clinical study is a pragmatic randomised trial over a period of 12 months to evaluate the efficacy, in terms of physical activity level, of an intervention based on structured information delivery according to cognitive and behavioural theories, a personalised written physical activity prescription in number of steps per day, a pedometer, and a pedometer logbook similar to diabetes logbooks, in 35 to 74 year old patients with cardiovascular risks factors. This strategy will be compared to the commonly used oral recommendation of physical activity. The primary outcome is the change in total energy expenditure measured by accelerometry over a 7-day period. Secondary outcomes include changes in physical activity levels (International Physical Activity Questionnaire), quality of life (SF-36), blood pressure, weight, waist circumference, perceived obstacles to physical activity, and patient and doctors compliance with the suggested strategy. 140 patients will be recruited and followed up in 15 GP practices. Measures will be assessed at baseline, at 3 months and at 12 months (end of intervention). The results of the PEPPER study are expected at the end of 2016. If the intervention proves effective in increasing durably the level of physical activity, this relatively simple and cheap strategy could help decrease the occurrence of cardiovascular events in a large high-risk population seen in general practice.

Official Title
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Physical Exercise Prescription With PEdometeR in General Practice for Patients With Cardiovascular Risk Factors - The PEPPER Pragmatic Randomised Controlled Trial

Conditions
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Sedentary Lifestyle, Cardiovascular Diseases, Hypertension, Hypercholesterolemia, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Intervention PPIL
* Behavioral: Control OR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients consulting their general practitioner for a non-urgent matter with regular follow-up every 3 months for hypertension, hypercholesterolaemia or non insulin dependent type 2 diabetes. judged insufficiently active by their general practitioner based on negative answers to the questions : Do you practice a physical activity or cycling more than an hour per week? and Does your occupation involve physical exertion? Exclusion Criteria: contraindication to moderate physical activity, non autonomous for walking, with cognitive or psychiatric impairment limiting the full understanding of the study, suffering from another limiting disease (coronary insufficiency, chronic cardiac failure, etc), who don't speak French, refusing to participate.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 74 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention PPIL<br>Intervention delivered by the family doctor and based on structured information delivery according to cognitive and behavioural theories, a personalised written physical activity prescription in number of steps per day, a pedometer, and a pedometer logbook similar to diabetes logbooks. | Behavioral: Intervention PPIL<br> <br> * Other names: Prescription, Pedometer, Information, Logbook;|
| Active Comparator: Control OR<br>Oral recommendation of physical exercise delivered by the family doctor. | Behavioral: Control OR<br> <br> * Other names: Oral recommendation of physical exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total energy expenditure by accelerometry at 3 months compared to baseline | The total energy expenditure is measured with a wGT3x-BT Actigraph accelerometer worn at the belt during 7 consecutive days from morning to evening. It is measured in Metabolic Equivalent Task-Minutes per Week. | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total energy expenditure by accelerometry at 12 months compared to baseline | The total energy expenditure is measured with a wGT3x-BT Actigraph accelerometer worn at the belt during 7 consecutive days from morning to evening. It is measured in Metabolic Equivalent Task-Minutes per Week. | baseline and 52 weeks | 
| Change in total energy expenditure by questionnaire at 3 months compared to baseline | The total energy expenditure is calculated with the self-administered International Physical Activity Questionaire (IPAQ) short version covering the past 7 days. It is expressed in Metabolic Equivalent Task-Minutes per Week. | baseline and 12 weeks | 
| Change in total energy expenditure by questionnaire at 12 months compared to baseline | The total energy expenditure is calculated with the self-administered International Physical Activity Questionaire (IPAQ) short version covering the past 7 days. It is expressed in Metabolic Equivalent Task-Minutes per Week. | baseline and 52 weeks | 
| Change in quality of life at 3 months compared to baseline | Change in quality of life as measured by the self-administered Short Form 36 questionnaire | baseline and 12 weeks | 
| Change in quality of life at 12 months compared to baseline | Change in quality of life as measured by the self-administered Short Form 36 questionnaire | baseline and 52 weeks | 
| Change in waist circumference at 3 months compared to baseline |  | baseline and 12 weeks | 
| Change in waist circumference at 12 months compared to baseline |  | baseline and 52 weeks | 
| Change in weight at 3 months compared to baseline |  | baseline and 12 weeks | 
| Change in weight at 12 months compared to baseline |  | baseline and 52 weeks | 
| Change in arterial blood pressure at 3 months compared to baseline |  | baseline and 12 weeks | 
| Change in arterial blood pressure at 12 months compared to baseline |  | baseline and 52 weeks | 
| Perceived obstacles to physical exercise | Perceived obstacles to physical exercise as measured by the Determinant of Physical Activity Questionnaire (DPAQ) | 52 weeks | 
| Adherence of doctors and patients to the suggested strategy |  | 12 weeks | 
| Adherence of doctors and patients to the suggested strategy |  | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical exercise, sedentarity, general practice, family medicine, pedometer