Clinical trial NCT02317003: Physical Exercise Prescription With PEdometeR in General Practice for Patients With Cardiovascular Risk Factors - PEPPER
Official title: Physical Exercise Prescription With PEdometeR in General Practice for Patients With Cardiovascular Risk Factors - The PEPPER Pragmatic Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Cardiovascular Diseases
Hypertension
Hypercholesterolemia
Diabetes Mellitus, Type 2
Keywords: physical exercise
sedentarity
general practice
family medicine
pedometer
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2014-12-15
Enrollment: 126
Sex: ALL
Minimum age (years): 35
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in total energy expenditure by accelerometry at 3 months compared to baseline
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Change in total energy expenditure by accelerometry at 12 months compared to baseline
timeFrame: baseline and 52 weeks
measure: Change in total energy expenditure by questionnaire at 3 months compared to baseline
timeFrame: baseline and 12 weeks
measure: Change in total energy expenditure by questionnaire at 12 months compared to baseline
timeFrame: baseline and 52 weeks
measure: Change in quality of life at 3 months compared to baseline
timeFrame: baseline and 12 weeks
measure: Change in quality of life at 12 months compared to baseline
timeFrame: baseline and 52 weeks
measure: Change in waist circumference at 3 months compared to baseline
timeFrame: baseline and 12 weeks
measure: Change in waist circumference at 12 months compared to baseline
timeFrame: baseline and 52 weeks
measure: Change in weight at 3 months compared to baseline
timeFrame: baseline and 12 weeks
measure: Change in weight at 12 months compared to baseline
timeFrame: baseline and 52 weeks
measure: Change in arterial blood pressure at 3 months compared to baseline
timeFrame: baseline and 12 weeks
measure: Change in arterial blood pressure at 12 months compared to baseline
timeFrame: baseline and 52 weeks
measure: Perceived obstacles to physical exercise
timeFrame: 52 weeks
measure: Adherence of doctors and patients to the suggested strategy
timeFrame: 12 weeks
measure: Adherence of doctors and patients to the suggested strategy
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
Study officials:
affiliation: University Hospital, Angers
name: Denise Jolivot, MD
role: STUDY_CHAIR
affiliation: Medical School, Angers
name: Laurent Connan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.