NCT03441737

Brief Summary

Although more than half of Canadian smokers in 2015 attempted to quit, with one-third attempting more than once, successful smoking cessation (quitting) remains a challenge. Relapse (return to smoking) has been attributed to failures in inhibitory control. Inhibitory control is the ability to suppress actions. Previous studies have identified that aerobic exercise improves inhibitory control and reduces the urge to smoke. This study will examine whether an acute bout of moderate intensity aerobic exercise (i.e. brisk walk on a treadmill) will improve inhibitory control, increase time to first cigarette smoked, and reduce urges to smoke during a brief period of abstinence. Inhibitory control will be assessed using the antisaccade task, which requires the participant to shift their gaze away from a visual target presented to them. Phase I will include assessments of smoking behaviours, physical activity levels, urges to smoke, and inhibitory control. Phase II will consist of a 12-hour smoking abstinence period conducted at home, followed by reassessment of urges to smoke and inhibitory control. Participants will then be randomized to either 20 minutes of aerobic exercise or sitting. Following the intervention, reassessment of urges to smoke, inhibitory control, and time to first cigarette smoked will be conducted.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2018

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 4, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

February 9, 2018

Last Update Submit

February 29, 2024

Conditions

Keywords

Aerobic exerciseAntisaccadesUrge to SmokeAdults

Outcome Measures

Primary Outcomes (1)

  • Inhibitory Control

    Cognitive computer task: Participant will be asked to complete a computer task which assesses inhibitory control (the cognitive ability to suppress responses to stimuli). The Antisaccade Task will be used to assess inhibitory control in this study. A saccade is a rapid eye movement towards a visual target. An antisaccade is a rapid eye movement away from a visual target. The ability to suppress making an eye movement towards a visual target gauges inhibitory control. The participant will be seated in a chair facing a computer screen in which visual stimuli (a cross) will appear. The participant will be fitted into a chin rest and a monocle will be adjusted so that images of eye movements can be assessed. A training phase will take place at the beginning of the task to familiarize the participant with the instructions. The participant will make a series of saccades and antisaccades. The reaction times and directional errors to the visual stimuli will be recorded.

    24 hours post participant start date

Secondary Outcomes (2)

  • Urge to Smoke

    24 hours post participant start date

  • Time to First Cigarette

    24 hours post participant start date

Study Arms (2)

Exercise

EXPERIMENTAL

Aerobic exercise intervention

Behavioral: Exercise

Non-Exercise

ACTIVE COMPARATOR

Non-aerobic exercise intervention

Behavioral: Non-Exercise

Interventions

ExerciseBEHAVIORAL

20 minutes of aerobic exercise (walking on a treadmill) at 2/3 of participant's maximum heart rate (maximum heart rate calculated as 220-age).

Exercise
Non-ExerciseBEHAVIORAL

20 minutes of sitting in the laboratory with access to magazines and the internet.

Non-Exercise

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • Smoke at least 10 cigarettes per day (or more) for at least 6 months
  • Able to perform a twenty-minute exercise task at a moderate intensity (2/3 of participant's maximum heart rate) without health implications
  • Can read and write in English
  • Have email or phone number for contacting purposes

You may not qualify if:

  • Do not have Chronic Obstructive Pulmonary Disease
  • Do not have a medical condition that prevents you from exercise (e.g. heart attack in the past year, heart disease, irregular heartbeat, etc.)
  • Do not have history of eye injury or neurological impairment
  • Do not have an orthopaedic limitation
  • Are not pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Smoking CessationInhibition, Psychological

Interventions

Exercise

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dr.Harry Prapavessis

    Western University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2018

First Posted

February 22, 2018

Study Start

April 1, 2018

Primary Completion

December 1, 2018

Study Completion

March 1, 2019

Last Updated

March 4, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share