Physical activity prescription by primary care nurses using health assets: Study design of a randomized controlled trial in patients with cardiovascular risk factors.

AIM: To analyse the efficacy of a 12-month multifactorial intervention by primary care nurses in increasing adherence to physical activity prescription (150 min/week) in patients with two or more cardiovascular risk factors and with cardiovascular risk up to 15% determined by the REGICOR equation.

BACKGROUND: In Spain, cardiovascular diseases are responsible for 30.5% of deaths. Regular physical activity decreases mortality risk due to cardiovascular diseases but the effectiveness of physical activity prescription in routine in primary care settings has been shown to be low.

DESIGN: Multicentre, single-blind, parallel randomized (in two different branches) clinical trial.

METHODS: At least 368 participants will be recruited (184 control and 184 intervention), to show an 8% increase in adherence to the physical activity prescription (1.2% control group and 9.2% intervention group). Participants will be patients aged 35-75 years with at least two cardiovascular risk factors and with a cardiovascular risk of up to 15% measured using the Framingham-REGICOR equation. Intervention will be performed throughout baseline and three follow-up visits. A motivational interview, the trans-theoretical stages of changes of Prochaska and DiClemente and an individualized prescription of physical exercise using physical activity assets will be used in the intervention. Data will be collected at baseline and after the 1-year intervention.

DISCUSSION: The present study will allow us to find out whether this brief multifactorial intervention induces greater adherence to physical activity prescription than usual practice, improving the quality of patient care.

TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN76069254. Protocol version 1.1, 6 July 2015.