Impact of Exercise Associated With Cognitive-behavioral Therapy in Smokers

NCT07186049 | Not Yet Recruiting DMC

• 1 other identifier: 02565743750
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking (Tobacco) Addiction

Keywords

Smoking; Physical exercise; Cognitive-behavioral therapy

Outcome Measures

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.

  12 weeks

Study Arms (3)

Group 3 General Health Guidelines.

ACTIVE COMPARATOR

General Health Guidelines

Behavioral: General Health Guidelines

Group 1 Thesis

ACTIVE COMPARATOR

Thesis Sessions

Behavioral: Thesis Sessions

Group 2 Thesis and Exercises

ACTIVE COMPARATOR

Thesis Sessions + Home Exercises

Behavioral: Thesis and Exercises

Interventions

Thesis Sessions BEHAVIORAL

Thesis Sessions

Group 1 Thesis

General Health Guidelines BEHAVIORAL

General Health Guidelines

Group 3 General Health Guidelines.

Thesis and Exercises BEHAVIORAL

Thesis and Exercises

Group 2 Thesis and Exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants 18 years of age or older;
• Clinical diagnosis of active smoking of combustible cigarettes;

You may not qualify if:

• Unstable heart disease or severe orthopedic problems;
• Cognitive disorders that may interfere with understanding and participation in behavioral interventions;

Sponsors & Collaborators

• Agnaldo José Lopes: lead

Study Sites (1)

PPC/UERJ - Piquet Carneiro University Polyclinic

Rio de Janeiro, Rio de Janeiro, 20950-003, Brazil

Location

MeSH Terms

Conditions

Smoking; Behavior, Addictive; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Compulsive Behavior; Impulsive Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Agnaldo J José

  Augusto Motta University Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JORGE M PINTO, doctoral student

CONTACT

21964443667; JORGETITIRY@GMAIL.COM

Agnaldo J Jose, Doctorate

CONTACT

21964443667; jorgetitiry@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor with a PhD

Model Details: Randomized Intervention Study

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 22, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

BR (1)