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CancerNCT01431365

Effect of an Acute Bout of Exercise on Smoking Topography

A study testing Moderate Exercise Group and Passive Sitting Group in people with Cancer, run by University of Western Ontario, Canada at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Cancer
What is being tested?
Moderate Exercise Group and Passive Sitting Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteCanada
Study dates
Aug 2011to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Exercise and Health Psychology Laboratory- University of Western Ontario

    London, Ontario

Other trials in Canada

About this study

Official title: Does an Acute Bout of Exercise Affect Smoking Topography?

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.

Read the detailed description

Lung cancer is the leading cause of cancer death in Canadians (Canadian Cancer Society, in which cigarette smoking is responsible for 85% of these cases. Smoking topography, a key facet of smoking behaviour, can be subjectively or objectively measured by quantifying puff volume, maximum puff velocity, interpuff interval, puff duration, number of puffs per cigarette, and the time to smoke a single cigarette. Smoking topography can estimate exposure to carcinogenic toxins present in cigarette smoking (Djordjevic, Hoffman, \& Hoffman, 1997). Evidence exists to support that exercise modifies smoking topography (Katomeri \& Taylor 2006; Mikhail, 1983; Reeser, 1983; Zacny \& Stitzer, 1985).

Recently, Faulkner and colleagues (2011; N = 18) were the first to implement a handheld smoking topography device (CReSS Pocket) to measure smoking behaviour in the context of an acute bout of exercise after a temporary period of abstinence. They found that brisk walking influences an individual's smoking topography. In specific, participants assigned to the exercise condition smoked less per puff and took shorter puff durations, compared to the passive sitting condition. Overall, smoking topographical studies require further investigation due to methodological flaws in order to allow for the objective collection of smoking behaviour data and improved external validity in a sufficiently powered study. Furthermore, the role of cravings, withdrawal and affect as potential mediators of topographical changes due to exercise is a novel area of research.

Conditions
Cancer
Being tested
Moderate Exercise Group, Passive Sitting Group
Keywords
exercise, topography, cravings, smoking behaviour
Medical subject headings
Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moderate Exercise GroupBehavioural

    Also called Physical activity

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

  • Passive Sitting GroupBehavioural

    Also called Sedentary

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

Study groups in NCT01431365
Study groupRoleWhat they receive
Moderate Exercise GroupExperimentalThe 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.
Receives: Behavioral: Moderate Exercise Group
Passive Sitting GroupActive comparatorThe 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.
Receives: Behavioral: Passive Sitting Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: One week

Secondary outcomes (1)

  1. Withdrawal symptoms

    Changes in cravings, positive and negative affect, and mood and physical symptoms will be assessed using three questionnaires.

    Measured: One week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01431365
Sponsor's protocol ID
SmokingTopography210
Status last verified
Dec 2014
First submitted
7 Sep 2011
Last updated
16 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17615224

  • 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.

    PubMed 18843632

  • 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.

    PubMed 17286639

  • 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.

    PubMed 17978993

  • 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.

    PubMed 4006371

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Moderate Exercise Group and Passive Sitting Group in people with Cancer, run by University of Western Ontario, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking topography (time frame: One week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01431365, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2014.

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