Physical Exercise Prescription With PEdometeR in General Practice for Patients With Cardiovascular Risk Factors - PEPPER (PEPPER)
Primary Purpose
Sedentary Lifestyle, Cardiovascular Diseases, Hypertension
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intervention PPIL
Control OR
Sponsored by
About this trial
This is an interventional prevention trial for Sedentary Lifestyle focused on measuring physical exercise, sedentarity, general practice, family medicine, pedometer
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.
Sites / Locations
- Angers University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention PPIL
Control OR
Arm Description
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.
Oral recommendation of physical exercise delivered by the family doctor.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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
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
Change in waist circumference at 3 months compared to baseline
Change in waist circumference at 12 months compared to baseline
Change in weight at 3 months compared to baseline
Change in weight at 12 months compared to baseline
Change in arterial blood pressure at 3 months compared to baseline
Change in arterial blood pressure at 12 months compared to baseline
Perceived obstacles to physical exercise
Perceived obstacles to physical exercise as measured by the Determinant of Physical Activity Questionnaire (DPAQ)
Adherence of doctors and patients to the suggested strategy
Adherence of doctors and patients to the suggested strategy
Full Information
NCT ID
NCT02317003
First Posted
December 10, 2014
Last Updated
July 28, 2022
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT02317003
Brief Title
Physical Exercise Prescription With PEdometeR in General Practice for Patients With Cardiovascular Risk Factors - PEPPER
Acronym
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 16, 2015 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Lifestyle, Cardiovascular Diseases, Hypertension, Hypercholesterolemia, Diabetes Mellitus, Type 2
Keywords
physical exercise, sedentarity, general practice, family medicine, pedometer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention PPIL
Arm Type
Experimental
Arm Description
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.
Arm Title
Control OR
Arm Type
Active Comparator
Arm Description
Oral recommendation of physical exercise delivered by the family doctor.
Intervention Type
Behavioral
Intervention Name(s)
Intervention PPIL
Other Intervention Name(s)
Prescription, Pedometer, Information, Logbook
Intervention Type
Behavioral
Intervention Name(s)
Control OR
Other Intervention Name(s)
Oral recommendation of physical exercise
Primary Outcome Measure Information:
Title
Change in total energy expenditure by accelerometry at 3 months compared to baseline
Description
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.
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in total energy expenditure by accelerometry at 12 months compared to baseline
Description
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.
Time Frame
baseline and 52 weeks
Title
Change in total energy expenditure by questionnaire at 3 months compared to baseline
Description
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.
Time Frame
baseline and 12 weeks
Title
Change in total energy expenditure by questionnaire at 12 months compared to baseline
Description
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.
Time Frame
baseline and 52 weeks
Title
Change in quality of life at 3 months compared to baseline
Description
Change in quality of life as measured by the self-administered Short Form 36 questionnaire
Time Frame
baseline and 12 weeks
Title
Change in quality of life at 12 months compared to baseline
Description
Change in quality of life as measured by the self-administered Short Form 36 questionnaire
Time Frame
baseline and 52 weeks
Title
Change in waist circumference at 3 months compared to baseline
Time Frame
baseline and 12 weeks
Title
Change in waist circumference at 12 months compared to baseline
Time Frame
baseline and 52 weeks
Title
Change in weight at 3 months compared to baseline
Time Frame
baseline and 12 weeks
Title
Change in weight at 12 months compared to baseline
Time Frame
baseline and 52 weeks
Title
Change in arterial blood pressure at 3 months compared to baseline
Time Frame
baseline and 12 weeks
Title
Change in arterial blood pressure at 12 months compared to baseline
Time Frame
baseline and 52 weeks
Title
Perceived obstacles to physical exercise
Description
Perceived obstacles to physical exercise as measured by the Determinant of Physical Activity Questionnaire (DPAQ)
Time Frame
52 weeks
Title
Adherence of doctors and patients to the suggested strategy
Time Frame
12 weeks
Title
Adherence of doctors and patients to the suggested strategy
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Jolivot, MD
Organizational Affiliation
University Hospital, Angers
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Laurent Connan, MD
Organizational Affiliation
Medical School, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Angers University Hospital
City
Angers
ZIP/Postal Code
49933
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
31159805
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.
Results Reference
derived
Learn more about this trial
Physical Exercise Prescription With PEdometeR in General Practice for Patients With Cardiovascular Risk Factors - PEPPER
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