Physical Activity as an Aid for Smoking Cessation (PHASMO)
Primary Purpose
Tobacco Dependence, Cardiovascular Diseases, Physical Activity
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Allez Hop
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Dependence focused on measuring smoking cessation, nicotine, physical activity
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A
B
Arm Description
a tailored physical activity intervention involving moderate-intensity exercise
Outcomes
Primary Outcome Measures
smoking cessation
Secondary Outcome Measures
weight change
Full Information
NCT ID
NCT00521391
First Posted
August 24, 2007
Last Updated
August 24, 2007
Sponsor
University of Lausanne Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT00521391
Brief Title
Physical Activity as an Aid for Smoking Cessation
Acronym
PHASMO
Official Title
Physical Activity as an Aid for Smoking Cessation: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Terminated
Why Stopped
End of the recruitment
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Lausanne Hospitals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence, Cardiovascular Diseases, Physical Activity
Keywords
smoking cessation, nicotine, physical activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
a tailored physical activity intervention involving moderate-intensity exercise
Arm Title
B
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Allez Hop
Intervention Description
a tailored physical activity intervention involving moderate-intensity exercise
Primary Outcome Measure Information:
Title
smoking cessation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
weight change
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Cornuz, MD
Organizational Affiliation
University of Lausanne
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
25187423
Citation
Gonseth S, Locatelli I, Bize R, Nussle S, Clair C, Pralong F, Cornuz J. Leptin and smoking cessation: secondary analyses of a randomized controlled trial assessing physical activity as an aid for smoking cessation. BMC Public Health. 2014 Sep 3;14:911. doi: 10.1186/1471-2458-14-911.
Results Reference
derived
PubMed Identifier
20798023
Citation
Bize R, Willi C, Chiolero A, Stoianov R, Payot S, Locatelli I, Cornuz J. Participation in a population-based physical activity programme as an aid for smoking cessation: a randomised trial. Tob Control. 2010 Dec;19(6):488-94. doi: 10.1136/tc.2009.030288. Epub 2010 Aug 25.
Results Reference
derived
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Physical Activity as an Aid for Smoking Cessation
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