Effects of Cognitive-behavioral Education and Exercise Interventions on Smoking Cessation

NCT05079958 | Unknown

• 1 other identifier: CGH-OP108004
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Smoking Cessation

Keywords

Coronary artery disease; Trans-theoretical Model; Smoking cessation

Outcome Measures

Primary Outcomes (2)

• Stage3-The change of smoking cessation success rate

  smoking cessation success

  12-weeks, three-month, and six month

• Stage2-The change of smoking cessation behavior

  Only one question, "Are you currently considering quitting smoking?" The smoking cessation behavior change stage is divided into 5 periods according to the cross-theoretical model, and they are respectively 1. Unintentional period: current smoking, and no smoking cessation will be considered in the next six months. 2. Intent period: currently smoking, but considering quitting in the next six months. 3. Preparation period: currently smoking, and plan to quit smoking within the nearest month. 4. Action period: I have quit smoking, but less than six months. 5. Maintenance period: I have quit smoking for more than six months.

  Before, 4-weeks.

Secondary Outcomes (8)

• Stage3-The change of Fagerstrom Test for Nicotine Dependence (FTND)

  12-weeks, three-month, and six month

• Stage3-The change of lung carbon monoxide concentration

  12-weeks, three-month, and six month

• Stage3-The change of heart rate variability

  12-weeks, three-month, and six month

• Stage3-The change of smoking withdrawal syndrome

  12-weeks, three-month, and six month

• Stage3-The change of the Center for Epidemiological Studies -Depression Scales (CESD-10)

  12-weeks, three-month, and six month

Study Arms (2)

Stage2 - cognitive-behavioral education

EXPERIMENTAL

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.

Behavioral: cognitive-behavioral education

Stage 3- 12-week brisk walking

EXPERIMENTAL

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.

Behavioral: 12-week brisk walking

Interventions

cognitive-behavioral education BEHAVIORAL

four-week cognitive-behavioral education course

Stage2 - cognitive-behavioral education

12-week brisk walking BEHAVIORAL

12-week brisk walking

Stage 3- 12-week brisk walking

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who meet the diagnosis and can perform aerobic exercise after being referred by a physician.
• Those who have a clear consciousness and have no mental disorders as recorded in medical records or verbally.
• Those who can walk on their own.
• Participated in the first or second phase of the study and the smoking cessation phase is in the preparation and action phases

You may not qualify if:

• Irregular heart rhythm.
• Install a heart regulator.
• Those who already have regular exercise (3 times a week, 20-30 minutes of physical activity each time).

Sponsors & Collaborators

• Cathay General Hospital: lead

Study Sites (1)

Cathay General Hospital

Taipei, 10648, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 28505303 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Smoking Cessation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Health Behavior; Behavior

Study Officials

• Fang-Chun Wei

  Cathay General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang-Chun Wei

CONTACT

+88627082121; wfc@cgh.org.tw

Yi-Min Lee

CONTACT

88627082121; yimin@cgh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: For the third stage, subjects 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.

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: October 15, 2021
• Study Start: October 30, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 15, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)