Effects of Cognitive-behavioral Education and Exercise Interventions on Smoking Cessation
NCT ID: NCT05079958
Last Updated: 2021-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
172 participants
INTERVENTIONAL
2019-10-30
2022-12-31
Brief Summary
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Detailed Description
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The purpose of the study is to adopt the Trans-theoretical Model to facilitate step-by-step changes in a patient's smoking behavior and explore the effect of "Cognitive-Behavioral Education Course" and "Exercise Program" on Smoking cessation, physical health, and mental health of smokers with CAD. This study is composed of three stages in three years period, recruiting patients (who meet the selection criteria) from the cardiology department of a medical center in northern Taiwan. For the first stage, a cross-sectional method will be employed to investigate the relationship between smoking status and various physiological and psychological indicators in patients with CAD. For the second stage, subjects who are at the smoking cessation stage of "precontemplation" and "contemplation" will be recruited.
A quasi-experimental design will be used to determine the effects of a four-week cognitive-behavioral education course related to smoking cessation on the participants' smoking cessation behavior, smoking decision-making, and self-efficacy in smoking cessation. For the third stage, subjects from Stages 1 and 2 who are at the "preparation " and "action" stage will be recruited and randomly divided into experimental or control group to identify the effect of a 12-week brisk walking on improving the participants' immediate (short-term), three-month, and six month (long-term) health status. The primary indicator used for health status evaluation is smoking cessation success rate; the secondary indicators used are physiological status (i.e., nicotine addiction, lung carbon monoxide concentration, heart rate variability, and smoking withdrawal syndrome) and psychological status (i.e., depression and resilience). SPSS for Window 24.0 software will be used in statistical analysis. The type one error is 0.05. In inferences analysis, chi-square test, Pearson correlation coefficient, independent t test, one-way ANOVA and post hoc comparison (scheffe) test will be used to examine the variance among groups. Finally, ANCOVA and GEE mode will be used to test the effectiveness of intervention at stage 1 and stage 2, respectively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Stage2 - cognitive-behavioral education
A quasi-experimental design will be used to determine the effects of a four-week cognitive-behavioral education course related to smoking cessation on the participants' smoking cessation behavior, smoking decision-making, and self-efficacy in smoking cessation.
cognitive-behavioral education
four-week cognitive-behavioral education course
Stage 3- 12-week brisk walking
Subjects who are at the "preparation " and "action" stage will be recruited and randomly divided into experimental or control group to identify the effect of a 12-week brisk walking on improving the participants' immediate (short-term), three-month, and six month (long-term) health status.
12-week brisk walking
12-week brisk walking
Interventions
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cognitive-behavioral education
four-week cognitive-behavioral education course
12-week brisk walking
12-week brisk walking
Eligibility Criteria
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Inclusion Criteria
2. Those who have a clear consciousness and have no mental disorders as recorded in medical records or verbally.
3. Those who can walk on their own.
4. Participated in the first or second phase of the study and the smoking cessation phase is in the preparation and action phases
Exclusion Criteria
2. Install a heart regulator.
3. Those who already have regular exercise (3 times a week, 20-30 minutes of physical activity each time).
20 Years
80 Years
ALL
No
Sponsors
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Cathay General Hospital
OTHER
Responsible Party
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Principal Investigators
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Fang-Chun Wei
Role: PRINCIPAL_INVESTIGATOR
Cathay General Hospital
Locations
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Cathay General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Abrantes AM, Farris SG, Minami H, Strong DR, Riebe D, Brown RA. Acute Effects of Aerobic Exercise on Affect and Smoking Craving in the Weeks Before and After a Cessation Attempt. Nicotine Tob Res. 2018 Apr 2;20(5):575-582. doi: 10.1093/ntr/ntx104.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CGH-OP108004
Identifier Type: -
Identifier Source: org_study_id