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Physical Activity as an Aid for Smoking Cessation (PHASMO)

This study has been terminated.
(End of the recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00521391
First Posted: August 27, 2007
Last Update Posted: August 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Lausanne Hospitals
  Purpose
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.

Condition Intervention Phase
Tobacco Dependence Cardiovascular Diseases Physical Activity Other: Allez Hop Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Activity as an Aid for Smoking Cessation: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • smoking cessation [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • weight change [ Time Frame: 12 months ]

Enrollment: 600
Study Start Date: April 2003
Study Completion Date: December 2005
Arms Assigned Interventions
Experimental: A
a tailored physical activity intervention involving moderate-intensity exercise
Other: Allez Hop
a tailored physical activity intervention involving moderate-intensity exercise
No Intervention: B

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521391


Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: Jacques Cornuz, MD University of Lausanne
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00521391     History of Changes
Other Study ID Numbers: 3200-0637200
First Submitted: August 24, 2007
First Posted: August 27, 2007
Last Update Posted: August 27, 2007
Last Verified: August 2007

Keywords provided by University of Lausanne Hospitals:
smoking cessation
nicotine
physical activity

Additional relevant MeSH terms:
Cardiovascular Diseases
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders