12-Month Efficacy of Exercise and Cytisinicline for Tobacco Abstinence

Current scientific evidence demonstrates the relationship between good physical fitness and a lower incidence of certain chronic diseases, including smoking, as well as the effectiveness of cytisinicline. This protocol aims to evaluate the efficacy of the synergistic effect of combining structured physical exercise, brief counseling, and cytisinicline administration in achieving smoking cessation. The study will be an experimental, multicenter, randomized, and controlled trial with two parallel arms, conducted by a multidisciplinary team within the primary care setting of the Andalusian public health system, with a 12-month follow-up. The estimated sample size is 75 participants per arm. One of the study arms will include a structured exercise program aligned with the recently approved regional Andalusian health plan.

NCT Number	NCT06579846
Lead Sponsor	Maimónides Biomedical Research Institute of Córdoba Collaborators: Universidad de Córdoba
Conditions	Smoking Cessation
Enrollment	150 participants
Start Date	2025-01-01
Primary Completion	2025-12-31 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2024-09-04