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 on at least five days a week. What we don''''t still know is how to help sedentary people to 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.

Condition	Intervention	Phase
Exercise Physical Fitness Quality of Life	Behavior: Experimental Programme for Physical Activity Promotion	Phase III

Further Study Details: 

Primary Outcomes: - Physical Activity Level (7-day PAR); - Cardiorespiratory and Physical Fitness; - Health Related Quality of life (SF-36)
Secondary Outcomes: Control of cardiovascular risk factors
Expected Total Enrollment:  5000

Despite sedentary behavior is one of the strongest risk factor 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 by 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, excepting 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. We will use mixed-effect models to take into account intra-patient, intra-doctor and intra-center correlation.

Ages Eligible for Study:  20 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Sedentary people who visit the general practitioner by any reason (those who do not dedicate at least 30 minutes to activities of at least moderate intensity on at least five days a week).

Exclusion Criteria:

• Disorders of the cardiovascular system
• Transplant recipients
• Renal or hepatic failure
• Severe Chronic Obstructive Pulmonary Disease
• Severe mental disorders
• Chronic and acute severe infections
• Metabolic uncontrolled disorders
• Restrictive pathology of muscles, bones and joints
• Complicated pregnancy
• Contact difficulties

Study chairs or principal investigators

Gonzalo Grandes, Dr.,  Principal Investigator,  Primary Care Research Unit of Bizkaia (Basque Health Service)   

Study ID Numbers:  PI020015-G03/170; PI020015; G03/170
Last Updated:  August 16, 2005
Record first received:  August 16, 2005
ClinicalTrials.gov Identifier:  NCT00131079
Health Authority: Spain: Ministry of Health
ClinicalTrials.gov processed this record on 2005-08-23