- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03453671
Strategies to Enhance the Experience of Exercise
October 10, 2018 updated by: University of Colorado, Boulder
This study aims to test the effect of three cognitive strategies to affect individuals' subjective experience of cardiovascular exercise.
Participants will be randomly assigned to one of three strategies to use while exercising, both during an in-person session and self-directed two week exercise period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Boulder, Colorado, United States, 80301
- Center for Innovation and Creativity (CINC)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between the ages of 18 and 40.
- Insufficiently physically active for the past 6-months (i.e., does not meet American College of Sports Medicine [ACSM] guideline for cardiorespiratory exercise). The ACSM guidelines state that all healthy adults should engage in a minimum of 150 minutes per week of moderate intensity cardiorespiratory exercise, or 75 minutes per week of vigorous intensity exercise, or an equivalent combination of the two). On the eligibility screen assessment, we will define moderate and vigorous intensity exercise. Then we will ask individuals to report how many minutes of moderate and vigorous intensity exercise they engage in per week. We will use the ACSM's rule of thumb that 1 minute of moderate intensity exercise is equivalent to 2 minutes of vigorous intensity exercise. This will help to ensure that prospective participants who exercise for less than 150 minutes per week are not actually meeting the ACSM guidelines for cardiorespiratory fitness by engaging in vigorous intensity exercise. Thus, if total minutes of moderate intensity exercise and total minutes of vigorous intensity exercise (multiplied by 2) per week is equal to or greater than 150, callers will not be eligible for study inclusion.
- Physically capable of safely engaging in moderate-intensity physical activity (PA)
- Able and willing to access the Internet daily for two weeks
- Willing to accept random assignment.
- Have a smartphone or other mobile device (e.g., iPod Touch) that can play media (important if participants are assigned to the distraction condition)
- Willing to engage in an exercise intervention specifically involving walking, jogging, running, or hiking (not other types of exercise)
Exclusion Criteria:
- Are diabetic or receiving treatment for a metabolic disorder
- Are currently pregnant
- Are currently on antipsychotic medications
- Have a history of cardiac or respiratory disease
- Are receiving treatment for a heart condition or high blood pressure
- Experience chest pains during and/or not during physical activity
- Have a muscle, bone, or joint problem or injury that limit movement, make exercise painful, or could be made worse by exercising
- Have a close family history of an adverse cardiac event before the age of 50.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness
Participants will use the strategy of mindfulness, i.e., present moment awareness with nonjudgment and acceptance, while exercising.
|
Participants will use mindfulness techniques while exercising
|
Experimental: Distraction
Participants will use the strategy of distraction, i.e., directing their attention to something other than exercise (specifically a podcast) while exercising.
|
Participants will distract themselves while exercising
|
Active Comparator: Self-Monitoring
Participants will monitor their internal experience while exercising, without distraction and without being taught mindfulness skills of nonjudgment and acceptance.
|
Participants will use associative attentional focus while exercising
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Affective valence
Time Frame: 30 minutes
|
Affective valence during a 30-minute exercise bout
|
30 minutes
|
Felt arousal
Time Frame: 30 minutes
|
Felt arousal during a 30-minute exercise bout
|
30 minutes
|
Perceived Exertion (RPE)
Time Frame: 30 minutes
|
Rating of Perceived Exertion during a 30-minute exercise bout
|
30 minutes
|
Minutes of exercise
Time Frame: 2-weeks following initial visit
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Minutes exercised during 2-week at-home intervention
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2-weeks following initial visit
|
Affect and perceived exertion: longitudinal
Time Frame: 2-weeks following initial visit
|
Rated affect and perceived exertion during 2-week at-home intervention
|
2-weeks following initial visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Theory of Planned Behavior: attitudes
Time Frame: Baseline to 2-week follow-up
|
attitudes about exercise behavior
|
Baseline to 2-week follow-up
|
Theory of Planned Behavior: norms
Time Frame: Baseline to 2-week follow-up
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subjective norms regarding exercise behavior
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Baseline to 2-week follow-up
|
Theory of Planned Behavior: self-efficacy
Time Frame: Baseline to 2-week follow-up
|
self-efficacy for exercise
|
Baseline to 2-week follow-up
|
Theory of Planned Behavior Constructs
Time Frame: Baseline to 2-week follow-up
|
intentions to engage in future exercise behavior
|
Baseline to 2-week follow-up
|
Distress tolerance
Time Frame: Baseline to 2-week follow-up
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Rated ability to tolerate distress
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Baseline to 2-week follow-up
|
Defusion skills
Time Frame: Baseline to 2-week follow-up
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rated ability to "defuse"
|
Baseline to 2-week follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2017
Primary Completion (Actual)
August 31, 2018
Study Completion (Actual)
August 31, 2018
Study Registration Dates
First Submitted
December 6, 2017
First Submitted That Met QC Criteria
February 26, 2018
First Posted (Actual)
March 5, 2018
Study Record Updates
Last Update Posted (Actual)
October 12, 2018
Last Update Submitted That Met QC Criteria
October 10, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 17-0474
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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