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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Hypertension; Diabetes Mellitus, Type 2; Sedentary Lifestyle; Hypercholesterolemia
• Intervention / Treatment: Behavioral: Intervention PPIL; Behavioral: Control OR

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Angers University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention PPIL; 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; Other Names: Prescription, Pedometer, Information, Logbook
Active Comparator: Control OR; Oral recommendation of physical exercise delivered by the family doctor.	Behavioral: Control OR; Other Names: Oral recommendation of physical exercise

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Study Chair: Denise Jolivot, MD, University Hospital, Angers; Principal Investigator: Laurent Connan, MD, Medical School, Angers

Publications and helpful links

General Publications

• Missud DC, Parot-Schinkel E, Connan L, Vielle B, Huez JF. Physical activity prescription for general practice patients with cardiovascular risk factors-the PEPPER randomised controlled trial protocol. BMC Public Health. 2019 Jun 3;19(1):688. doi: 10.1186/s12889-019-7048-y.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2015
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: December 10, 2014
• First Submitted That Met QC Criteria: December 12, 2014
• First Posted (Estimate): December 15, 2014

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: physical exercise; sedentarity; family medicine; general practice; pedometer
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Hypercholesterolemia
• Other Study ID Numbers: CHU-P 2014-04