NCT01431365

Brief Summary

Smokers will complete questionnaires and smoking behaviour will be examined. After abstaining from smoking for approximately 18 hours, they will be randomized to a moderate intensity exercise group or passive sitting group. Smoking behaviour (time to first puff) will be assessed following treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

3.3 years

First QC Date

September 7, 2011

Last Update Submit

December 12, 2014

Conditions

Keywords

exercisetopographycravingssmoking behaviour

Outcome Measures

Primary Outcomes (1)

  • Smoking topography

    Smoking topography will be assessed using the Clinical Research Support System (CReSS) Pocket, a computer-based, battery-powered, hand-held unit by Plowshare Technologies®. The CReSS Pocket has an orifice flow meter mouthpiece, and a pressure drop related to the flow rate that is produced when a puff is taken. From the flow rate, the CReSS derives puff count (number of puffs per cigarette), puff volume (the volume of carbon monoxide take in during each puff), puff duration (length of time for each puff), inter-puff interval (amount of time between puffs), and time to first puff.

    One week

Secondary Outcomes (1)

  • Withdrawal symptoms

    One week

Study Arms (2)

Moderate Exercise Group

EXPERIMENTAL

The moderate exercise condition will involve participants walking briskly (equivalent to moderate intensity) on a treadmill for 10 minutes. Moderate intensity exercise will be defined as 40-68% of the resting heart rate reserve. Heart rate (HR) will be monitored in participants using a Polar RS100 Heart Rate monitor to serve as a guide for participants to attain the appropriate intensity.

Behavioral: Moderate Exercise Group

Passive Sitting Group

ACTIVE COMPARATOR

The passive sitting condition will involve participants sitting passively for 10 minutes on a chair. Heart rate (HR) will be monitored in participants of the passive sitting group to help maintain group equivalency (with the moderate exercise condition) in regards to distraction effects and researcher contact.

Behavioral: Passive Sitting Group

Interventions

Participants will be required to walk briskly (equivalent to moderate intensity) on a treadmill for 10 minutes.

Also known as: Physical activity
Moderate Exercise Group

Participants will be required to sit passively for 10 minutes on a chair.

Also known as: Sedentary
Passive Sitting Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 64 years of age
  • Smoke 10 cigarettes or more per day
  • Not have any medical condition that is contraindicative for exercise
  • Not be pregnant or intending on being pregnant over the course of the study
  • Be able to read and write in English
  • Have a telephone or an email account so that they can be contacted
  • Completed the Physical Activity Readiness Questionnaire (PAR-Q)
  • Have Medical Doctor's clearance if they answer "YES" to one or more questions on the Physical Activity Readiness Questionnaire (PAR-Q)
  • Have not been engaged in a serious quit attempt in the last six months
  • Have been smoking for more than 2 years
  • Must not be suffering from an illness (e.g. cold) that would affect their typical smoking behaviour

You may not qualify if:

  • Contraindication to exercise (e.g., disability, unstable angina)
  • On medication for physical and/or mental health reasons that would make compliance with the study protocol difficult or dangerous
  • Have substance dependency problems (e.g., alcohol)
  • Are pregnant
  • Be younger than 18 years of age
  • Be 64 years or older prior to completion of the study
  • Have been engaged in a serious quit attempt in the last six months
  • Have been smoking for less than 2 years
  • Suffering from an illness (e.g. cold) that would affect their typical smoking behaviour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise and Health Psychology Laboratory- University of Western Ontario

London, Ontario, Canada

Location

Related Publications (6)

  • Aveyard P, West R. Managing smoking cessation. BMJ. 2007 Jul 7;335(7609):37-41. doi: 10.1136/bmj.39252.591806.47. No abstract available.

    PMID: 17615224BACKGROUND
  • Ussher MH, Taylor A, Faulkner G. Exercise interventions for smoking cessation. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD002295. doi: 10.1002/14651858.CD002295.pub3.

    PMID: 18843632BACKGROUND
  • Taylor AH, Ussher MH, Faulkner G. The acute effects of exercise on cigarette cravings, withdrawal symptoms, affect and smoking behaviour: a systematic review. Addiction. 2007 Apr;102(4):534-43. doi: 10.1111/j.1360-0443.2006.01739.x.

    PMID: 17286639BACKGROUND
  • Taylor A, Katomeri M. Walking reduces cue-elicited cigarette cravings and withdrawal symptoms, and delays ad libitum smoking. Nicotine Tob Res. 2007 Nov;9(11):1183-90. doi: 10.1080/14622200701648896.

    PMID: 17978993BACKGROUND
  • Zacny JP, Stitzer ML. Effects of smoke deprivation interval on puff topography. Clin Pharmacol Ther. 1985 Jul;38(1):109-15. doi: 10.1038/clpt.1985.143.

    PMID: 4006371BACKGROUND
  • Faulkner GE, Arbour-Nicitopoulos KP, & Hsin A. Cutting down one puff at a time: The acute effects of exercise on smoking behavior. Journal of Smoking Cessation (5): 130-135, 2010.

    BACKGROUND

Related Links

MeSH Terms

Conditions

NeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Harry Prapavessis, Ph.D.

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 7, 2011

First Posted

September 9, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 16, 2014

Record last verified: 2014-12

Locations