YMCA Exercise Intervention for Smoking Cessation Study

NCT03080090 | Completed

• 1 other identifier: 2016-12-0049
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Cigarette smoking is the leading cause of death and disability in the United States. Although smoking has declined since 1964, it is still very common among some groups of people. One such group is persons with emotional symptoms and disorders. There has been little success in developing treatments for smoking cessation for smokers with affective disturbances. Recent work suggests that being sensitive to, and less tolerant of, stress is associated with many problems in daily life. People with high 'stress sensitivity' tend to use avoidant strategies to cope with their stress, like smoking. Also, people with high levels of stress sensitivity report stronger beliefs that smoking will reduce negative feelings. They also report having a harder time quitting and in fact, are less successful at doing so. This information suggests that stress sensitivity is important to target during smoking cessation treatment for smokers with affective vulnerabilities. This clinical trial will evaluate a treatment that integrates exercise to reduce stress sensitivity among high stress sensitive smokers. It builds directly from our recent work and we now seek to adapt it to a more a more accessible and sustainable application. Results will provide important information on the benefit of an integrated intervention that could be used in the community for smokers at great risk for relapse and who do not benefit from existing alternative treatments. This study is the first to test an intervention for stress sensitive smokers and has the potential to help at-risk individuals experience quitting success and, ultimately, reduce the burden of tobacco-related cancers in Texas.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (5)

• Smoking Status after Quit Attempt

  Change from baseline in point prevalence abstinence (PPA) after quit attempt at week 6 of the protocol.

  6 weeks

• Smoking Status 1 Month after Quit Attempt

  Change from baseline in point prevalence abstinence (PPA) after quit attempt at week 10 of the protocol.

  Week 10

• Smoking Status 2 Months after Quit Attempt

  Change from baseline in point prevalence abstinence (PPA) after quit attempt at week 14 of the protocol.

  Week 14

• Smoking Status 3 Months after Quit Attempt

  Change from baseline in point prevalence abstinence (PPA) after quit attempt at week 18 of the protocol.

  Week 18

• Smoking Status 6 Months after Quit Attempt

  Change from baseline in point prevalence abstinence (PPA) after quit attempt at week 30 of the protocol.

  Week 30

Study Arms (2)

High Intensity Exercise

EXPERIMENTAL

Individuals in this condition will engage in aerobic exercise 3 times a week for 25 minutes each at 60% to 85% of age-predicted HRmax and smoking cessation intervention through a national quitline while using nicotine replacement patches.

Behavioral: Aerobic exercise; Behavioral: Smoking Cessation Intervention

Low Intensity Exercise

ACTIVE COMPARATOR

The intervention procedures for this group are identical to the Experimental Group group except that the target training intensity will be low intensity exercise, self-selected at 20% to 40% of age-predicted HRmax.

Behavioral: Aerobic exercise; Behavioral: Smoking Cessation Intervention

Interventions

Aerobic exercise BEHAVIORAL

Individuals will work with a YMCA personal trainer to engage in aerobic exercise 3 times a week (25 mins each) for 15 weeks.

High Intensity Exercise; Low Intensity Exercise

Smoking Cessation Intervention BEHAVIORAL

Individuals will work with a national quitline to help them with their smoking cessation goals and make a quit attempt at week 5 of the program.

High Intensity Exercise; Low Intensity Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants ages 18-65
• Willing and able to provide informed consent, attend all study visits and comply with the protocol
• Daily smoker for at least one year
• Currently smoke an average of at least 5 cigarettes per day
• Report a motivation to quit smoking in the next month of at least 5 on a 10-point scale.
• Anxiety Sensitivity Index-3 score ≥ 23 (cut-off score to identify high AS individuals)
• Sedentary as defined by moderate-intensity exercise less than 3 days/wk for at least 20 minutes each time
• Medical clearance to participate in the protocol

You may not qualify if:

• Use of other tobacco products (including e-cigarettes)
• A lifetime history of bipolar disorder, schizophrenia, psychosis, or delusional disorders; an eating disorder in the past 6 months; organic brain syndrome, mental retardation or other cognitive dysfunction that could interfere with capacity to engage in therapy; a history of substance or alcohol abuse or dependence (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol use during the acute period of study participation.
• Patients with significant suicidal ideation as determined by structured interview or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
• Body mass index 40. We selected a BMI of 39.9 as the upper limit in order to screen out individuals with Class III obesity who might be more prone to musculoskeletal injuries than individuals with a BMI\<40.0).
• Current use of any psychotherapy for smoking cessation not provided by the researchers.
• Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt, including Chantix, Zyban, and Nicotine Replacement Treatment.

Sponsors & Collaborators

• University of Texas at Austin: lead
• Cancer Prevention Research Institute of Texas: collaborator
• YMCA: collaborator

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (2)

• Smits JAJ, Rinck M, Rosenfield D, Beevers CG, Brown RA, Conroy Busch HE, Dutcher CD, Perrone A, Zvolensky MJ, Garey L. Approach bias retraining to augment smoking cessation: A pilot randomized controlled trial. Drug Alcohol Depend. 2022 Sep 1;238:109579. doi: 10.1016/j.drugalcdep.2022.109579. Epub 2022 Jul 25.

  PMID: 35917763 DERIVED

• Smits JAJ, Zvolensky MJ, Rosenfield D, Brown RA, Otto MW, Dutcher CD, Papini S, Freeman SZ, DiVita A, Perrone A, Garey L. Community-based smoking cessation treatment for adults with high anxiety sensitivity: a randomized clinical trial. Addiction. 2021 Nov;116(11):3188-3197. doi: 10.1111/add.15586. Epub 2021 Jun 13.

  PMID: 34033178 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Exercise

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 15, 2017
• Study Start: April 12, 2017
• Primary Completion: July 6, 2020
• Study Completion: July 6, 2020
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)