Quality of Life Clinical Trial
Official title:
Multi-center Evaluation of the Experimental Program for Physical Activity Promotion (PEPAF), Carried Out by Family Physicians
The potential health gains from active lifestyles are very well-known and it is recommended that all adults dedicate at least 30 minutes to activities of at least moderate intensity at least five days a week. What is still not known is how to help sedentary people follow this recommendation, by means of brief interventions feasible in routine general practice. This multi-center study was designed to evaluate the effectiveness of a physical activity promotion program (called PEPAF) implemented in 56 general practices of the Spanish public primary health care system. The study will test the capacity of the program to increase the physical activity level, physical fitness and health related quality of life of sedentary people.
Despite sedentary behavior being one of the strongest risk factors for chronic diseases and
mortality, most of the population remains sedentary and evidence is inconclusive that
counseling adults in the primary care setting to increase physical activity is effective.
The OBJECTIVE of this randomized clinical trial was to evaluate the effectiveness of an
innovative programme to promote physical activity (called PEPAF) implemented by family
doctors into daily routine practice. Doctors randomly allocated to the PEPAF group identified
sedentary people who visited them for any reason, diagnosed their stage of change and
prescribed a written plan of physical activity with those patients ready to change. Those not
prepared to change were briefly counseled and given printed materials to motivate them.
Patients with cardiovascular disease or other problems meaning that exercise could cause
adverse effects were excluded.
Participating people will be followed for 24 months to measure the increase in the level of
physical activity from baseline measurement to 6, 12 and 24 months, using 7-day physical
activity recall. Health-related quality of life and cardiorespiratory fitness (submaximal
cycle ergometer test) will also be measured.
People assigned to the PEPAF group will be COMPARED to patients of family doctors randomly
assigned to the control group in which any systematic intervention on physical activity
promotion has been postponed until year 2006, except for those patients whose health problems
were directly related to a sedentary lifestyle. The average changes observed in the two
groups will be compared, on the basis of intention to treat through analysis of covariance.
The investigators will use mixed-effect models to take into account intra-patient,
intra-doctor and intra-center correlation.
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