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.
Aged between 18 and 65 years.
Smoking a minimum of 10 cigarettes per day.
In the contemplation or action stage according to Prochaska and DiClemente's Transtheoretical Model.
Prepared to initiate smoking cessation treatment imminently and with commitment.
Individuals with medical conditions that contraindicate participation in physical exercise, including but not limited to malignant hypertension, heart failure, hyperthyroidism, peripheral arterial disease, or other conditions deemed by the research team to pose a risk of adverse events or significantly impair adherence to the study.
Individuals who have experienced changes in their usual treatment regimen within the past 90 days.
Individuals unable to provide informed consent.
Individuals with pathological conditions that significantly reduce life expectancy to less than 5 years.
Parallel
Cytisinicline and exercise
DrugDoctors will provide brief, personalized counseling anti-smoking plan. This counseling will support smokers in the determination-action phase of behavior change. Physicians will administer cytisine as follows: 1 tablet every 2 hours (maximum 6 per day) from days 1-3; every 2.5 hours (maximum 5 per day) from days 4-12; every 3 hours (maximum 4 per day) from days 13-16; every 5 hours (maximum 3 per day) from days 17-20; and 1-2 tablets per day (maximum 2 per day) from days 21-25. Participants will follow a combined aerobic and strength exercise program. This includes at least 150 minutes of moderate-intensity aerobic physical activity per week, or 75 minutes of vigorous-intensity aerobic activity, or an equivalent combination of both. Aerobic activity should be performed in sessions lasting at least 10 minutes.
Cytisinicline
DrugSame intervention as the experimental group without directed exercise prescription
Smoking
Number of cigarettes smoked daily.
Smoking cessation
Dichotomous variable (yes/not) asking in the clinical history.
Carbon monoxide exhaled air
Carbon monoxide in the subject's exhaled air. It will be measured with a Co-oximeter of the brand "Co Check", code 01PLS18B, with a sensitivity of 1 ppm and accuracy (repeatability) of 2%. The unit of measurement of the variable is parts per million (ppm).
Blood pressure
Blood pressure is measured in the non-dominant arm three times, with a 5-minute gap between each measurement, using an automatic oscillometer (Omron M3 Intellisense HEM-75051-EV; IOMRON Healthcare Europe) equipped with a child-specific cuff. The average of the three measurements is recorded for both systolic and diastolic blood pressure. The mean blood pressure values are expressed in mmHg.
Weight
Weight in grams is measured by the precision weighing scale model Tanita 780PMA.
Body mass index
Body mass index in kilograms per square meter is calculated.
Physical dependence on nicotine
Physical dependence on nicotine measured by the Fagerström Test for Nicotine Dependence (FTND). This test consists of 6 questions, and each question has response options with assigned scores. The total score is the sum of the response scores and ranges from 0 to 10 points. The scoring scale is interpreted as follows: 0-2 points: Low dependence. 3-4 points: Low to moderate dependence. 5 points: Moderate dependence. 6-7 points: High dependence. 8-10 points: Very high dependence.
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Maimónides Biomedical Research Institute of Córdoba
Lead sponsor
Universidad de Córdoba
Collaborator
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