BACKGROUND: We evaluate the effectiveness of a physical activity promotion programme carried out by general practitioners with inactive patients in routine care. METHODS AND FINDINGS: Pragmatic, cluster randomised clinical trial conducted in eleven public primary care centres in Spain. Fifty-six general practitioners (GPs) were randomly assigned to intervention (29) or standard care (27) groups. They assessed the physical activity level of a systematic sample of patients in routine practice and recruited 4,317 individuals (2,248 intervention and 2,069 control) who did not meet minimum physical activity recommendations. Intervention GPs provided advice to all patients and a physical activity prescription to the subgroup attending an additional appointment (30%). A third of these prescriptions were opportunistically repeated. Control GPs provided standard care. Primary outcome measure was the change in self-reported physical activity from baseline to six, 12 and 24 months. Secondary outcomes included cardiorespiratory fitness and health-related quality of life. A total of 3,691 patients (85%) were included in the longitudinal analysis and overall trends over the whole 24 month follow-up were significantly better in the intervention group (p < 0.01). The greatest differences with the control group were observed at six months (adjusted difference 1.7 MET-hr/wk (95% CI 0.8 to 2.6), 25 min/wk (95% CI 11.3 to 38.4), and a 5.3% higher percentage of patients meeting minimum recommendations (95% CI 2.1% to 8.8%), NNT 19). These differences were not statistically significant at 12 and 24 months. No differences were found in secondary outcomes. A significant difference was maintained until 24 months in the proportion of patients achieving minimum recommendation in the subgroup that received a repeat prescription (adjusted difference 10.2%, 95% CI 1.5% to 19.4%). CONCLUSIONS: General practitioners are effective at increasing the level of physical activity among their inactive patients during the initial six-months of an intervention but this effect wears off at 12 and 24 months. Only in the subgroup of patients receiving repeat prescriptions of physical activity is the effect maintained in long-term. TRIAL REGISTRATION: ClinicalTrials.gov NCT00131079.

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