Physical Activity as an Aid for Smoking Cessation

Cardiovascular Diseases Clinical Trial

— PHASMO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00521391
• Other study ID #: 3200-0637200
• Secondary ID: 3200-0637200
• Status: Terminated
• Phase: Phase 3
• First received: August 24, 2007
• Last updated: August 24, 2007
• Start date: April 2003
• Est. completion date: December 2005

Study information

• Verified date: August 2007
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 600
• Est. completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Current daily smoker >10 or more cigarettes per day

2. Having smoked (on average > 10 cigarettes/day) regularly for at least 3 years

3. Age between 18 and 65 years

4. Sedentary lifestyle defined as less than 20 minutes a day of moderate-intensity physical assessed by the Swiss Baseline Questionnaire.

Exclusion Criteria:

1. Current pharmacological agent use to quit smoking

2. Medical problems that would alter training responses: arthritis, heart disease, and orthopedic problems

3. Presence of an unstable medical condition

4. Current or recent major cardiovascular event, such as recent myocardial infarction (>12 months) or stroke, angina pectoris, major arrhythmia

5. Current psychiatric illness

6. Alcohol (> 4 drinks/day for men and > 3 drink/d. for women), or/and other substance abuse

7. Current or planned pregnancy

8. Systematic skin disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Physical Activity
• Tobacco Dependence

Intervention

Other:
• Allez Hop
a tailored physical activity intervention involving moderate-intensity exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	smoking cessation		12 months
Secondary	weight change		12 months