Physical Activity as an Aid for Smoking Cessation | NCT00521391

Studies
Physical Activity as an Aid for Smoking Cessation

NCT00521391

Sponsor

University of Lausanne Hospitals

Status

Terminated

Last Update Posted

Aug 27, 2007Estimated

Enrollment

600Actual

Phase

Phase 3

Conditions

Tobacco Dependence
Cardiovascular Diseases
Physical Activity

Interventions

Allez Hop

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
3200-0637200

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

End of the recruitment

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Not provided

Completion Date

Dec 2005Actual

First Submitted Date

Aug 24, 2007

First Submission Date that Met QC Criteria

Aug 24, 2007

First Posted Date

Aug 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2007

Last Update Posted Date

Aug 27, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	a tailored physical activity intervention involving moderate-intensity exercise	Other: Allez Hop
B	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Allez Hop	Other	a tailored physical activity intervention involving moderate-intensity exercise	A

Measure	Description	Time Frame
smoking cessation		12 months

Measure	Description	Time Frame
weight change		12 months

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jacques Cornuz, MD	University of Lausanne	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25187423	Derived	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.
20798023	Derived	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.

ID	Term
D014029	Tobacco Use Disorder
D002318	Cardiovascular Diseases
D009043	Motor Activity
D016540	Smoking Cessation

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D001519	Behavior