Physical Activity as an Aid for Smoking Cessation (PHASMO)

August 24, 2007 updated by: University of Lausanne Hospitals

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
smoking cessation
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
weight change
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Investigators

  • Principal Investigator: Jacques Cornuz, MD, University of Lausanne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion

December 7, 2022

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

August 24, 2007

First Submitted That Met QC Criteria

August 24, 2007

First Posted (Estimate)

August 27, 2007

Study Record Updates

Last Update Posted (Estimate)

August 27, 2007

Last Update Submitted That Met QC Criteria

August 24, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3200-0637200

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe