Physical Exercise Prescription With PEdometeR in General Practice for Patients With Cardiovascular Risk Factors - PEPPER
Condition: Sedentary Lifestyle; Cardiovascular Diseases; Hypertension; Hypercholesterolemia; Diabetes Mellitus, Type 2
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus, Type 2; Hypercholesterolemia
Study type: Interventional

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.
    

Intervention name(s): Intervention PPIL; Control OR
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): Prescription, Pedometer, Information, Logbook; Oral recommendation of physical exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: physical exercise; sedentarity; general practice; family medicine; pedometer