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Physical Activity as an Aid for Smoking Cessation (PHASMO)

This study has been terminated.
(End of the recruitment)
Sponsor:
Information provided by:
University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00521391
First received: August 24, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Physical Activity as an Aid for Smoking Cessation: a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521391

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

No publications provided

ClinicalTrials.gov Identifier: NCT00521391     History of Changes
Other Study ID Numbers: 3200-0637200, 3200-0637200
Study First Received: August 24, 2007
Last Updated: August 24, 2007
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Smoking
Tobacco Use Disorder
 Habits
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013