MEDSEC-CTA12
Multicenter Experimental Study to Evaluate the Efficacy in Tobacco AbstinEnce At 12 Months of DIrected Exercise and CyTisinicline
Sponsor study identifier
interventional
150
0 countries
N/A
Study Start
January 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 29, 2024
Actual (reported)August 30, 2024
Actual (reported)January 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Smoking
Number of cigarettes smoked daily.
Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365
Smoking cessation
Dichotomous variable (yes/not) asking in the clinical history.
Day 30; Day; 60; Day 90; Day 180; Day 365
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).
Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365
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
Smokers who will receive directed physical exercise and brief counseling while undergoing treatment according to the care process.
Smokers who will receive an informational leaflet and brief counseling when they begin cytisinicline treatment, according to the care process.
Doctors 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.
First Submitted
August 29, 2024
First Posted
August 30, 2024
Study Start
January 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2025
Estimated (date passed)Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking
Effect of Smoking Reduction on Endothelial Glucocalyx and Vascular Function
Same intervention as the experimental group without directed exercise prescription
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Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 4, 2024
Record last verified: 2024-08
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Source: ClinicalTrials.gov.
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