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AzTrials

CancerNCT01417975

Effect of an Acute Bout of Exercise on Smoking Satisfaction

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

Female and male smokers will complete questionnaires and smoking behavior will be examined. After abstaining from smoking for approximately 18 hours, they will be randomized to a moderate intensity exercise groups or passive sitting group. Smoking satisfaction and smoking behavior will be assessed following treatment. Read more about this study

Who is it for?
Ages 18 to 64 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
43 participants
Where
1 siteCanada
Study dates
Aug 2011to Apr 2012
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 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18 to 64 years of age
  • Smoke 10 or more cigarettes per day
  • Not have any medical condition that is contraindicative for exercise
  • Not be pregnant or intending on becoming pregnant over the course of the study
  • Be able to read and write in English
  • Have a telephone or e-mail account so they can be contacted
Show all 11Show fewer
  • Successful completion of the Physical Activity Readiness Questionnaire (PAR-Q)
  • Have a 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 quite 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

  • The Exercise and Health Psychology Laboratory - The University of Western Ontario

    London, Ontario

Other trials in Canada

About this study

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

Female and male smokers will complete questionnaires and smoking behavior will be examined. After abstaining from smoking for approximately 18 hours, they will be randomized to a moderate intensity exercise groups or passive sitting group. Smoking satisfaction and smoking behavior will be assessed following treatment.

The hypotheses detailed below are specific to the randomization of participants into the following 2 groups:

Read more
  1. Moderate exercise (Experimental condition; MEG)
  2. Passive sitting (Attention control condition; PSG)

Hypothesis 1: A bout of moderate intensity exercise will be associated with decreased smoking satisfaction after a temporary period of abstinence compared to a control condition.

Hypothesis 2: Smoking topographic measures will mediate the relationship between a bout of moderate intensity exercise and smoking satisfaction.

Read the detailed description

Lung cancer is the leading cause of cancer death in Canadians (Canadian Cancer Society (CCS), 2010). Cigarette smoking is responsible for 85% of these cases (CCS, 2007). Exercise has been shown to be an effective adjunct to pharmacological cessation strategies (Ussher, Taylor, \& Faulkner, 2008). A recent systematic review concluded that a single bout of low to moderate intensity exercise can help regulate cravings, withdrawal symptoms and negative affect associated with quitting (Taylor, Ussher, \& Faulkner, 2007).

Smoking satisfaction is an immediately reinforcing effect of nicotine. Smoking satisfaction may outweigh the temporally distant adverse health risks of smoking (Cappelleri, Bushmakin, Baker, Merikle, Olufade, \& Gilbert, 2007). Varenicline, an alpha 4-beta-2 nAChR partial agonist, mimics the effect of nicotine by reducing cravings and withdrawal symptoms (Coe et al., 2005). A 12-week treatment period of varenicline has been shown to reduce smoking satisfaction (Jorenby et al., 2006). However, the effect of acute exercise on smoking satisfaction is not yet known.

Smoking topography is a key facet of smoking behaviour. Smoking behaviour can be subjectively or objectively measured by quantifying puff volume, maximum puff velocity, inter-puff interval, puff duration, number of puffs per cigarette and 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).

Conditions
Cancer
Being tested
Moderate Exercise Group, Passive Sitting Group
Keywords
exercise, smoking satisfaction, topography, cravings
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 on a chair for 10 minutes.

Study groups in NCT01417975
Study groupRoleWhat they receive
Moderate Exercise GroupExperimentalThe moderate exercise condition will involve participants waking briskly (equivalent to moderate intensity) on a treadmill for 10 minutes. Moderate intensity exercise is defined as 40-68% of heart rate reserve (HRR). Heart rate (HR) will be monitored 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 in a chair for 10 minutes. Heart rate (HR) will be monitored in participants of the passive sitting group to help maintain group equivalency (with the moderate exercise condition) with 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 satisfaction

    Smoking satisfaction will be assessed using the 12-item modified version of the Cigarette Evaluation Questionnaire (mCEQ; Cappelleri, Bushmakin, Baker, Merikle, Olufade \& Gilbert, 2007).

    Measured: One week

Secondary outcomes (1)

  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 taken 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

Timeline

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

  1. First posted16 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionApr 2012
  4. Study completionApr 2012

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
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01417975
Sponsor's protocol ID
SmokingTopography1114
Status last verified
Jun 2012
First submitted
15 Aug 2011
Last updated
16 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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

  • West R, Baker CL, Cappelleri JC, Bushmakin AG. Effect of varenicline and bupropion SR on craving, nicotine withdrawal symptoms, and rewarding effects of smoking during a quit attempt. Psychopharmacology (Berl). 2008 Apr;197(3):371-7. doi: 10.1007/s00213-007-1041-3. Epub 2007 Dec 15.

    PubMed 18084743

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 satisfaction (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 NCT01417975, which also lists 4 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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