Impact of Exercise Associated With Cognitive-behavioral Therapy in Smokers: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The smoking cessation rate
研究概览
简要总结
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.
详细描述
Detailed Description of the Thesis Title: Impact of Exercise Combined with Cognitive-Behavioral Therapy in Smokers: A Randomized Clinical Trial
Objectives
General Objective:
To evaluate the effects of combining physical exercise interventions with cognitive-behavioral therapy on smoking cessation among adult smokers.
Specific Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants 18 years of age or older;
- •Clinical diagnosis of active smoking of combustible cigarettes;
排除标准
- •Unstable heart disease or severe orthopedic problems;
- •Cognitive disorders that may interfere with understanding and participation in behavioral interventions;
研究组 & 干预措施
Group 3 General Health Guidelines.
General Health Guidelines
干预措施: General Health Guidelines (Behavioral)
Group 1 Thesis
Thesis Sessions
干预措施: Thesis Sessions (Behavioral)
Group 2 Thesis and Exercises
Thesis Sessions + Home Exercises
干预措施: Thesis and Exercises (Behavioral)
结局指标
主要结局
The smoking cessation rate
时间窗: 12 weeks
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.
次要结局
未报告次要终点
研究者
Agnaldo José Lopes
Doctor with a PhD
Centro Universitário Augusto Motta
