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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
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Dependence focused on measuring smoking cessation, nicotine, physical activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

    First Posted
    August 24, 2007
    Last Updated
    August 24, 2007
    Sponsor
    University of Lausanne Hospitals
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    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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