Multicentre Pilot Study to Evaluate the Efficacy of Targeted Exercise in Combination with Cytisinicline on Smoking Cessation at 12 Months: MEDSEC-CTA

<b>Background/Objectives:</b> Current scientific evidence shows both the relationship between good physical condition and a lower incidence of certain chronic diseases (including smoking), as well as the efficacy of cytisinicline. The aim of this protocol is to evaluate the efficacy of the synergistic effect of the combination of targeted physical exercise, together with brief advice and taking the drug cytisinicline, to achieve smoking cessation. <b>Methods</b>: We propose an experimental, multicentre, randomised, controlled study with two parallel arms to be carried out by a multidisciplinary team in the primary care setting of the Andalusian public health system (APHS) in Spain, with a follow-up of 12 months. The population sample will include people who are aged between 18 and 65 years and meet the criteria to be eligible for treatment with cytisinicline financed by the APHS: smokers of 10 or more cigarettes per day who are in the determination/action phase for smoking cessation of the transtheoretical model of Prochaska and Diclemente, willing to start anti-smoking treatment imminently and confirmed, with high dependence to nicotine (Fagerström's test ≥ 7), with a motivation to quit smoking according to the Richmond test (≥6), and who have made a previous smoking cessation attempt in the last year. The study consists of two treatment arms. EXPERIMENTAL ARM: Smokers who are going to be prescribed targeted physical exercise and brief advice to stop smoking while receiving cytisinicline treatment (1.5 mg tablets) according to the care process. CONTROL ARM: Smokers will receive a standard leaflet explaining physical exercise to the general population and brief advice on smoking cessation when starting cytisinicline treatment, according to the care process. The calculated sample size is 75 participants per arm. <b>Results:</b> The primary results will allow us to estimate the efficacy of prescribing physical exercise as an adjuvant therapy to classic multicomponent treatment, incorporating it as an additional element to be considered when it is accepted by the smoker. <b>Conclusions:</b> This protocol (NCT06579846) evaluates the efficacy of combining physical exercise, brief advice, and cytisinicline to support smoking cessation, improve fitness, and reduce smoking-related comorbidities.