Impact of Exercise Associated With Cognitive-behavioral Therapy in Smokers

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAgnaldo José Lopes

About this trial

Smoking remains one of the leading causes of global morbidity and mortality, responsible for more than 8 million deaths annually, according to data from the World Health Organization. In addition to its physical effects, such as cancer, cardiovascular, and respiratory diseases, tobacco use also negatively impacts mental health and quality of life (QoL). Despite public health measures, its prevalence remains high, especially among vulnerable groups, requiring integrated approaches that address both the physiological and psychological aspects of addiction.

This study aims to evaluate the effects of combining physical exercise and cognitive behavioral therapy (CBT) on smoking cessation. Specifically, it seeks to assess the effectiveness of a structured exercise program in promoting abstinence, improving physical and mental health, and reducing cigarette consumption, as well as analyzing the impacts on fatigue, lung function, exercise capacity, and quality of life of participants over a 12-week intervention.

Methodologically, a randomized clinical trial will be conducted with 66 smokers recruited from the Piquet Carneiro Polyclinic of the Rio de Janeiro State University. Participants will be randomly assigned to three groups: CBT alone, CBT combined with structured exercises, and a control group with general health counseling. Assessments will include spirometry, impulse oscillometry, the FACIT-Fatigue scale, the Fagerström test, a cardiopulmonary exercise test, and the SF-36 questionnaire, administered at three time points: baseline, 6 weeks, and 12 weeks.

The combination of exercise and CBT is expected to significantly increase abstinence rates, promoting improvements in physical and mental health parameters, reduced cigarette consumption, increased exercise capacity, improved lung function, and decreased fatigue. Furthermore, a reduction in anxiety and depression levels is expected, reflecting the effectiveness of behavioral strategies in modulating the psychological factors associated with smoking.

This study is highly relevant to Rehabilitation Sciences, as it proposes an integrated intervention that can support the development of more effective and holistic public health programs aligned with national targets and the Sustainable Development Goals. By exploring the interface between physical activity, mental health, and smoking cessation, it contributes to the training of more qualified health professionals and the advancement of patient-centered rehabilitation strategies, promoting sustainable benefits to public health.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants 18 years of age or older;

Clinical diagnosis of active smoking of combustible cigarettes;

Disqualifiers

Unstable heart disease or severe orthopedic problems;

Cognitive disorders that may interfere with understanding and participation in behavioral interventions;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thesis Sessions

    Behavioral

    Thesis Sessions

  • General Health Guidelines

    Behavioral

    General Health Guidelines

  • Thesis and Exercises

    Behavioral

    Thesis and Exercises

Treatment groups

66 Participants
are divided into 3 treatment groups
Group A: Group 3 General Health Guidelines.Active comparator 1 intervention
Group B: Group 1 ThesisActive comparator 1 intervention
Group C: Group 2 Thesis and ExercisesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The smoking cessation rate

The primary outcome of this study is the smoking cessation rate, defined as the percentage of participants who remain abstinent from tobacco use during the follow-up period. To ensure the robustness of the results, abstinence will be verified by participants' self-reports and confirmed by biochemical measures performed by physicians, such as blood cotinine levels and/or exhaled carbon monoxide (CO) testing. The selection of this primary outcome is based on the clinical relevance of achieving smoking cessation, as it contributes to improved individual health and serves as a direct indicator of the effectiveness of the proposed combined intervention.

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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Agnaldo José Lopes

Lead sponsor

Centro Universitário Augusto Motta

Sponsor institution

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