Physical Activity as an Aid for Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
Including a tailored moderate-intensity physical activity intervention in a standard smoking cessation treatment program (pharmaceutical treatment and counseling) increases the chances of quitting and reduces nicotine withdrawal symptoms, negative moods, stress, and weight gain.

Detailed Description
-----------------
The main objective is to determine whether a tailored physical activity intervention involving moderate-intensity exercise is an added value to a standard smoking cessation intervention in term of likelihood of smoking abstinence. The secondary objectives are 1) to determine whether this tailored physical activity intervention prevents weight gain, reduces withdrawal symptoms, stress and improve mood and self-confidence in quitting; 2) to assess the effect of this tailored physical activity intervention on body composition and leptin concentration. We assess this intervention in a randomized controlled trial of 600 sedentary adults regular smokers recruited from the community allocated into one of the two groups (intervention group vs. control group) during a 10-week period and 3 follow-up visits (6 and 12 months follow-up). All subjects (intervention and control groups) participate in a smoking cessation program composed of a pharmacological treatment (including nicotine replacement therapy) and counseling. The intervention group attend the 10-week physical activity program blending moderate-intensity exercise (Swiss nationwide implemented program entitled Allez Hop!) and lifestyle physical activity and the control group a 10-week health education program to ensure equal contact condition.

Official Title
-----------------
Physical Activity as an Aid for Smoking Cessation: a Randomized Controlled Trial

Conditions
-----------------
Tobacco Dependence, Cardiovascular Diseases, Physical Activity

Intervention / Treatment
-----------------
* Other: Allez Hop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current daily smoker >10 or more cigarettes per day Having smoked (on average > 10 cigarettes/day) regularly for at least 3 years Age between 18 and 65 years Sedentary lifestyle defined as less than 20 minutes a day of moderate-intensity physical assessed by the Swiss Baseline Questionnaire. Exclusion Criteria: Current pharmacological agent use to quit smoking Medical problems that would alter training responses: arthritis, heart disease, and orthopedic problems Presence of an unstable medical condition Current or recent major cardiovascular event, such as recent myocardial infarction (>12 months) or stroke, angina pectoris, major arrhythmia Current psychiatric illness Alcohol (> 4 drinks/day for men and > 3 drink/d. for women), or/and other substance abuse Current or planned pregnancy Systematic skin disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>a tailored physical activity intervention involving moderate-intensity exercise | Other: Allez Hop<br>* a tailored physical activity intervention involving moderate-intensity exercise<br>|
| No Intervention: B<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoking cessation |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight change |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking cessation, nicotine, physical activity