Effects of Yoga and Cardiovascular Exercise on Smoking Motivation

Not Applicable

Completed

• Conditions: Tobacco Dependence
• Interventions: Behavioral: Cardiovascular Exercise (CE); Behavioral: Hatha Yoga (HY); Behavioral: Smoking Cessation Counseling

• Registration Number: NCT01423578
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

The overall purpose of this pilot study is to examine effects of Hatha yoga and cardiovascular exercise on craving, mood, cue reactivity, and smoking behavior. Our preliminary study indicated that a single session of either form of activity intervention improved mood, and the yoga intervention appeared to decrease cravings to smoke. The proposed study will extend this preliminary research in several ways.

Detailed Description

First, the investigators will expand the exercise-based interventions from one to three sessions, which will more closely resemble how these interventions may be used in the context of smoking cessation. Second, the investigators will recruit smokers who are motivated to quit smoking, further increasing the clinical relevance of the research. Finally, the investigators will examine the effects of the interventions on actual smoking behavior within and outside of the laboratory setting. This may appropriately be considered a "proof of concept" study, as the investigators will not be powered to detect treatment outcome (smoking cessation) differences, nor are the interventions designed to maximize clinical smoking cessation outcomes.

Participants will be randomized to receive 3-sessions of yoga instruction, 3-sessions of cardiovascular exercise, or to a no activity control group. Sessions will be scheduled to occur approximately 7 days apart, with a minimum of 4 between sessions. Mood and craving will be assessed before and after each session, and smoking behavior will be assessed following each session. Finally, a detailed cue reactivity assessment will be conducted prior to the first session and following the last session. Analyses will examine intervention effects on craving, mood, cue reactivity, and smoking behavior. In addition, the investigators will examine several potential mediators and moderators of intervention effects on smoking behavior. Finally, the investigators will continue to examine the feasibility and potential acceptability of each active intervention, to assist in developing future clinical applications of these techniques in the context of smoking cessation.

Study Timeline

• Study Start: 2007-08-21
• Primary Completion: 2011-05-02
• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-08-25
• Study First Posted: 2011-08-26
• Status Verified: 2017-06
• Study Completion: 2017-06-20
• Last Update Submitted: 2017-06-23
• Last Update Posted: 2017-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• Smoke at least 10 cigarettes per day
• Smoked regularly at least 2 years
• Carbon monoxide reading at least 8 ppm
• Interest in quitting smoking
• Able to read and understand the consent form and questionnaires
• Not currently practicing yoga

Exclusion Criteria

• Current Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) (American Psychiatric Association, 1994) psychosis
• Major depressive episode, manic episode, or panic disorder
• Current DSM-IV psychoactive substance dependence or use
• Current medication use that might affect physiological responses
• Current use of bupropion, varenicline, or nicotine-containing products other than cigarettes
• Significant health problems that might compromise physiological data collection or be contraindicated for moderate physical exercise or yoga
• Significant hearing or visual impairment; pregnant as determined by urine human chorionic gonadotropin (hCG) test or nursing females
• Body mass index (BMI) 35 or greater

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hatha Yoga (HY)	Smoking Cessation Counseling	Exercise and Smoking Cessation Counseling
Cardiovascular Exercise (CE)	Cardiovascular Exercise (CE)	Exercise and Smoking Cessation Counseling
Cardiovascular Exercise (CE)	Smoking Cessation Counseling	Exercise and Smoking Cessation Counseling
Smoking Cessation Counseling Only	Smoking Cessation Counseling	Control Group - Smoking Cessation Counseling
Hatha Yoga (HY)	Hatha Yoga (HY)	Exercise and Smoking Cessation Counseling

Primary Outcome Measures

Name	Time	Method
The Number of Participants Reporting Post Intervention Effects	Average of 6 Months	Intervention effects on measures of craving, mood, cue reactivity, and smoking behavior will be analyzed with mixed-design analysis of variance (ANOVA), with Intervention as the between-group factor (HY vs. CE vs. NA), and Time as a within-subject factor (pre vs. post-intervention). Analyses for cue reactivity variables will include the additional within-subject factor of Cue Type (smoking vs. neutral), and analyses for craving and mood self-report will include the additional within-subject factor of Session (1 vs. 2 vs. 3).

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting Behavior Changes Post Intervention	Average of 6 Months	In order to determine whether intervention effects on smoking behavior are mediated by changes in craving, mood, and/or cue reactivity, we will conduct Sobel tests (e.g., Preacher \& Leonardelli, 2001), supplemented by mediation analyses using methods of Baron \& Kenny (1986).

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States