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Completed

NCT Number: NCT02317003

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention PPIL

Behavioral

Other names: Prescription, Pedometer, Information, Logbook

Control OR

Behavioral

Other names: Oral recommendation of physical exercise

Primary outcomes

  1. Change in total energy expenditure by accelerometry at 3 months compared to baseline

    Time frame: baseline and 12 weeks

    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.

Secondary outcomes

  1. Change in total energy expenditure by accelerometry at 12 months compared to baseline

    Time frame: baseline and 52 weeks

    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.

  2. Change in total energy expenditure by questionnaire at 3 months compared to baseline

    Time frame: baseline and 12 weeks

    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.

  3. Change in total energy expenditure by questionnaire at 12 months compared to baseline

    Time frame: baseline and 52 weeks

    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.

  4. Change in quality of life at 3 months compared to baseline

    Time frame: baseline and 12 weeks

    Change in quality of life as measured by the self-administered Short Form 36 questionnaire

  5. Change in quality of life at 12 months compared to baseline

    Time frame: baseline and 52 weeks

    Change in quality of life as measured by the self-administered Short Form 36 questionnaire

  6. Change in waist circumference at 3 months compared to baseline

    Time frame: baseline and 12 weeks

  7. Change in waist circumference at 12 months compared to baseline

    Time frame: baseline and 52 weeks

  8. Change in weight at 3 months compared to baseline

    Time frame: baseline and 12 weeks

  9. Change in weight at 12 months compared to baseline

    Time frame: baseline and 52 weeks

  10. Change in arterial blood pressure at 3 months compared to baseline

    Time frame: baseline and 12 weeks

  11. Change in arterial blood pressure at 12 months compared to baseline

    Time frame: baseline and 52 weeks

  12. Perceived obstacles to physical exercise

    Time frame: 52 weeks

    Perceived obstacles to physical exercise as measured by the Determinant of Physical Activity Questionnaire (DPAQ)

  13. Adherence of doctors and patients to the suggested strategy

    Time frame: 12 weeks

  14. Adherence of doctors and patients to the suggested strategy

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: PEPPER

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 15, 2014
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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