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临床试验/NCT07186049
NCT07186049尚未招募不适用

Impact of Exercise Associated With Cognitive-behavioral Therapy in Smokers: a Randomized Clinical Trial

Agnaldo José Lopes1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年10月22日最近更新:
适应症
干预措施

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.

Active Comparator

General Health Guidelines

干预措施: General Health Guidelines (Behavioral)

Group 1 Thesis

Active Comparator

Thesis Sessions

干预措施: Thesis Sessions (Behavioral)

Group 2 Thesis and Exercises

Active Comparator

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

发起方
Agnaldo José Lopes
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Agnaldo José Lopes

Doctor with a PhD

Centro Universitário Augusto Motta

研究点 (1)

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