Multicenter Experimental Study to Evaluate the Efficacy in Tobacco AbstinEnce At 12 Months of DIrected Exercise and CyTisinicline
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Smoking Cessation
- Sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Enrollment
- 150
- Primary Endpoint
- Smoking
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •Demonstrating a high level of nicotine dependence, with a Fagerström test score of 7 or higher.
- •Exhibiting significant motivation to quit smoking, as indicated by a Richmond test score of 6 or higher.
- •Having made at least one prior attempt to quit smoking within the past year.
- •Enrolled in or covered by the Andalusian Public Health System.
Exclusion Criteria
- •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.
- •Individuals with contraindications as specified in the product information for cytisinicline , such as pregnancy, breastfeeding, hypersensitivity to cytisinicline, unstable angina, recent myocardial infarction, clinically significant arrhythmias, or recent stroke.
Outcomes
Primary Outcomes
Smoking
Time Frame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365
Number of cigarettes smoked daily.
Smoking cessation
Time Frame: Day 30; Day; 60; Day 90; Day 180; Day 365
Dichotomous variable (yes/not) asking in the clinical history.
Carbon monoxide exhaled air
Time Frame: Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365
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).
Secondary Outcomes
- Blood pressure(Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365)
- Weight(Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365)
- Body mass index(Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365)
- Physical dependence on nicotine(Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365)
- Psychological dependence on smoking(Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365)
- Motivation to quit smoking(Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365)
- Alcohol consumption(Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365)
- Physical activity(Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365)
- Self-efficacy for physical activity(Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365)
- Heart rate in rest(Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365)