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

NCT02317003 | Completed

• 1 other identifier: CHU-P 2014-04
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

physical exercise; sedentarity; general practice; family medicine; pedometer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

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

  baseline and 52 weeks

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

  baseline and 12 weeks

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

  baseline and 52 weeks

• Change in quality of life at 3 months compared to baseline

  baseline and 12 weeks

• Change in quality of life at 12 months compared to baseline

  baseline and 52 weeks

Study Arms (2)

Intervention PPIL

EXPERIMENTAL

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

Control OR

ACTIVE COMPARATOR

Oral recommendation of physical exercise delivered by the family doctor.

Behavioral: Control OR

Interventions

Intervention PPIL BEHAVIORAL

Also known as: Prescription, Pedometer, Information, Logbook

Intervention PPIL

Control OR BEHAVIORAL

Also known as: Oral recommendation of physical exercise

Control OR

Eligibility Criteria

• Age: 35 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?"

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Angers University Hospital

Angers, 49933, France

Location

Related Publications (2)

• 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.

  PMID: 37475036 DERIVED

• 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.

  PMID: 31159805 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Cardiovascular Diseases; Hypertension; Hypercholesterolemia; Diabetes Mellitus, Type 2; Motor Activity

Interventions

Prescriptions

Condition Hierarchy (Ancestors)

Behavior; Vascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Denise Jolivot, MD

  University Hospital, Angers

  STUDY CHAIR

• Laurent Connan, MD

  Medical School, Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 15, 2014
• Study Start: March 16, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 2, 2022

Record last verified: 2018-08

Locations

FR (1)