NCT01423578

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2017

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

3.7 years

First QC Date

August 24, 2011

Last Update Submit

June 23, 2017

Conditions

Tobacco Dependence

Keywords

cravingmoodcue reactivitysmoking behaviorquit smokingpreventionHatha yogacardiovascular exercise

Outcome Measures

Primary Outcomes (1)

  • The Number of Participants Reporting Post Intervention Effects

    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).

    Average of 6 Months

Secondary Outcomes (1)

  • Number of Participants Reporting Behavior Changes Post Intervention

    Average of 6 Months

Study Arms (3)

Hatha Yoga (HY)

ACTIVE COMPARATOR

Exercise and Smoking Cessation Counseling

Behavioral: Hatha Yoga (HY)Behavioral: Smoking Cessation Counseling

Cardiovascular Exercise (CE)

EXPERIMENTAL

Exercise and Smoking Cessation Counseling

Behavioral: Cardiovascular Exercise (CE)Behavioral: Smoking Cessation Counseling

Smoking Cessation Counseling Only

OTHER

Control Group - Smoking Cessation Counseling

Behavioral: Smoking Cessation Counseling

Interventions

Hatha Yoga (HY)BEHAVIORAL

3 Sessions of yoga instruction

Also known as: yoga
Hatha Yoga (HY)
Cardiovascular Exercise (CE)BEHAVIORAL

3 sessions of cardiovascular exercise

Also known as: exercise
Cardiovascular Exercise (CE)
Smoking Cessation CounselingBEHAVIORAL

4 smoking cessation counseling visits.

Also known as: control group
Cardiovascular Exercise (CE)Hatha Yoga (HY)Smoking Cessation Counseling Only

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderSmoking

Interventions

YogaExerciseControl Groups

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • David J. Drobes, Ph.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2011

First Posted

August 26, 2011

Study Start

August 21, 2007

Primary Completion

May 2, 2011

Study Completion

June 20, 2017

Last Updated

June 26, 2017

Record last verified: 2017-06

Locations

US(1)