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

NCT ID: NCT02317003

Last Updated: 2022-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-16
• Study Completion Date: 2018-08-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intervention PPIL

Intervention Type: BEHAVIORAL

Control OR

Oral recommendation of physical exercise delivered by the family doctor.

Group Type: ACTIVE_COMPARATOR

Control OR

Intervention Type: BEHAVIORAL

Interventions

Intervention PPIL

Intervention Type: BEHAVIORAL

Control OR

Intervention Type: BEHAVIORAL

Other Intervention Names

Prescription, Pedometer, Information, Logbook; Oral recommendation of physical exercise

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denise Jolivot, MD

Role: STUDY_CHAIR

University Hospital, Angers

Laurent Connan, MD

Role: PRINCIPAL_INVESTIGATOR

Medical School, Angers

Locations

Angers University Hospital

Angers, , France

Countries

France

References

Bellanger W, Peurois M, Connan L, Navasiolava N, Missud D, Py T, Begue C. Comparing physical activity prescription with verbal advice for general practice patients with cardiovascular risk factors: results from the PEPPER randomised controlled trial. BMC Public Health. 2023 Jul 20;23(1):1402. doi: 10.1186/s12889-023-16302-6.

Reference Type: DERIVED

PMID: 37475036 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31159805 (View on PubMed)

Other Identifiers

CHU-P 2014-04

Identifier Type: -

Identifier Source: org_study_id