Acute Effects of Exercise in Smokers With Schizophrenia

Study Overview
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Brief Summary
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People with schizophrenia have two- to three-times the mortality risk of the general population. This is primarily due to their unusually high rates of cigarette smoking, as well as other cardiovascular risk factors such as physical inactivity, obesity, high blood cholesterol and diabetes. Effective smoking treatments are needed to reduce morbidity and mortality in this population. Over a dozen experimental studies indicate that walking and other forms of exercise acutely reduce cigarette craving, nicotine withdrawal symptoms and smoking behavior in non-psychiatric smokers. However, the effects of acute exercise on smoking measures have not been studied in smokers with schizophrenia. This study will use a within-subjects, repeated-measures design, in which participants will undergo 4 laboratory sessions (order counterbalanced across participants): (1) smoking cues followed by exercise, (2) smoking cues followed by passive activity, (3) neutral cues followed by exercise, (4) neutral cues followed by passive activity. Outcome measures include cigarette craving, nicotine withdrawal symptoms, mood and smoking behavior. If the results of this study indicate that walking acutely reduces craving and smoking in smokers with schizophrenia, the next step in this research would be to test the effectiveness of a smoking cessation intervention that incorporates exercise bouts as a behavioral strategy for improving smoking cessation rates in this population.

Official Title
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Acute Effects of Exercise in Smokers With Schizophrenia

Conditions
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Tobacco Dependence, Cigarette Craving, Smoking Behavior

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: passive control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of schizophrenia smoke at least 20 cigarettes per day less than 60 min moderate-intensity exercise per week Exclusion Criteria: medication changes in past 4 weeks unable to give informed consent to participate alcohol/drug screen pregnant or nursing receiving or seeking immediate smoking treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>1-mile treadmill walk | Behavioral: Exercise<br>* 1-mile treadmill walk<br>|
| Placebo Comparator: Passive<br>20 min inactivity | Behavioral: passive control<br>* 20 min inactivity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarette craving | Questionnaire on Smoking Urges - Brief form | within 10 minutes before and after exercise (or control activity) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood | Positive and Negative Affect Scales, which are brief questionnaire measures of positive and negative mood. | within 10 minutes before and after exercise (or control activity) | 
| Smoking habit withdrawal | Questionnaire measures of withdrawal from sensorimotor aspects of smoking | within 10 minutes before and after exercise (or control activity) | 
| Smoking choice | 2-hr laboratory smoking choice assessment in which participants make a series of choices between smoking versus receiving a small amount of cash. | initiated 10 minutes after exercise (or control activity) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychiatric, comorbidity, craving, tobacco