An interventional study of Intervention PPIL and Control OR in Sedentary Lifestyle, Cardiovascular Diseases and Hypertension, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 35 Years to 74 Years. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by University Hospital, Angers · Not applicable, Interventional, and Prevention
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.
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.
367 studies on the registry are indexed under Sedentary Behavior; 165 are open to participants now.
This study's enrollment of 126 is above the median of 70 across 314 interventional studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →University Hospital, Angers is the lead sponsor of 477 studies on the registry; 119 are open to participants now.
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Exclusion Criteria:
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
Oral recommendation of physical exercise delivered by the family doctor.
Behavioral: Control OR
Also known as: Prescription, Pedometer, Information, Logbook
Also known as: Oral recommendation of physical exercise
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.
Time frame: baseline and 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: baseline and 52 weeks
Change in waist circumference at 3 months compared to baseline
Time frame: baseline and 12 weeks
Change in waist circumference at 12 months compared to baseline
Time frame: baseline and 52 weeks
Change in weight at 3 months compared to baseline
Time frame: baseline and 12 weeks
Change in weight at 12 months compared to baseline
Time frame: baseline and 52 weeks
Change in arterial blood pressure at 3 months compared to baseline
Time frame: baseline and 12 weeks
Change in arterial blood pressure at 12 months compared to baseline
Time frame: baseline and 52 weeks
Perceived obstacles to physical exercise
Perceived obstacles to physical exercise as measured by the Determinant of Physical Activity Questionnaire (DPAQ)
Time frame: 52 weeks
Adherence of doctors and patients to the suggested strategy
Time frame: 12 weeks
Adherence of doctors and patients to the suggested strategy
Time frame: 52 weeks
Ran from Mar 2015 to primary completion in Aug 2018, 40 months.
Of 243 non-industry interventional studies with no phase under Sedentary Behavior, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's 40 months is above that.
Counting every sponsor, half of 246 studies reached it within 22 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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