- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02560792
Tailored Activity Goals - an Exercise Prescription Study (TAG)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The specific aims are as follows:
Aim 1. The first aim is to determine the effectiveness of an experimental manipulation of individuals' affective response to a laboratory-supervised bout of exercise corresponding to a vigorous intensity (just below the ventilatory threshold), compared to a control condition that simply measures individuals' natural affective response to exercise. The investigators will specifically determine the effect of this manipulation on anticipated, experienced and remembered affective response to exercise.
Aim 2. The second aim is to examine individuals' adherence to an exercise prescription over the course of one week that asks them to exercise daily on their own for twenty minutes at the same intensity (as indicated by a heart rate monitor) as the laboratory-supervised exercise session, and to determine whether adherence to this prescription is greater for those who expect exercise to lead to positive affect than those who expect exercise to lead to negative affect, as compared to a control condition.
Aim 3. The third aim is to examine potential mediators and moderators of the relationship between anticipated affect and subsequent exercise behavior, including volitional control of exercise, affect regulation ability, and symptoms of depression.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- eligible participants will be between the ages of 18 and 39 (for men) and 18 and 45 (for women)
- free of overt disease (as cleared by clinical translational research center medical staff)
- free of mental health conditions other than depression and anxiety (by self-report)
- physically capable of engaging in moderate exercise activity (i.e., no injuries or physical impairments)
- willing to receive a "prescription" for exercise intensity, frequency, and duration, and have access to a computer with Internet connectivity in order to complete the online follow-up survey.
Exclusion Criteria:
- elite (i.e., paid) athletes or required to participate in aerobic exercise in conjunction with their occupation (e.g., aerobics instructors)
- women must not be pregnant or planning to become pregnant during the study period
- on any medications for which exercise is contraindicated (as cleared by clinical translational research center medical staff)
- smoker
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Positive Affect Condition
Participants read that their exercise prescription was a healthy level of intensity for exercise, and then read that most people indicated this level of intensity leads to positive affect.
To further encourage participants to think about how the supposed typical affective response might apply to them personally, they were also asked to describe how they thought the exercise might lead to positive feelings.
|
Participants read: "Most people exercising at this intensity say that it feels good, and that it makes them feel energized and more positive, and more relaxed afterwards.
Thinking about your exercise prescription, please list the reasons or ways in which you, personally, might expect this exercise to lead to positive feelings, and what specifically about this exercise might make you, personally, feel good."
|
|
Experimental: Negative Affect Condition
Participants read that their exercise prescription was a healthy level of intensity for exercise, and then read that most people indicated this level of intensity leads to negative affect.
To further encourage participants to think about how the supposed typical affective response might apply to them personally, they were also asked to describe how they thought the exercise might lead to negative feelings.
|
Participants read: "Most people exercising at this intensity say that it doesn't feel very good, and that it makes them feel tired and not so positive, and not very relaxed afterwards.
Thinking about your exercise prescription, please list the reasons or ways in which you, personally, might expect this exercise to lead to negative feelings, and what specifically about this exercise might make you, personally, feel bad."
|
|
Experimental: Control Condition
Participants read that their exercise prescription was a healthy level of intensity for exercise - affect was not mentioned.
|
Participants receive no information about affective response
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Days of exercise according to prescription as measured by exercise log
Time Frame: 7 days
|
Number of days of prescribed exercise recorded on exercise log
|
7 days
|
|
Days of exercise according to prescription as measured by heart rate monitor
Time Frame: 7 days
|
Number of days of prescribed exercise recorded by heart rate monitor
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intentions to exercise according to prescription as measured by intention to exercise scale
Time Frame: 5 minutes post-intervention
|
Self-report survey: intention to exercise scale
|
5 minutes post-intervention
|
|
Volitional control of exercise: Planning as measured by exercise planning scale
Time Frame: 7 days post-intervention
|
Self-report survey: exercise planning scale
|
7 days post-intervention
|
|
Volitional control of exercise: Commitment as measured by commitment to exercise scale
Time Frame: 7 days post-intervention
|
Self-report survey: commitment to exercise scale
|
7 days post-intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive activated affect as measured by Physical Activity Affect Scale
Time Frame: 5 minutes before, 10 and 20 minutes during, and 5 minutes after intervention
|
Self-report survey: Physical Activity Affect Scale, positive affect subscale
|
5 minutes before, 10 and 20 minutes during, and 5 minutes after intervention
|
|
Negative activated affect as measured by Physical Activity Affect Scale
Time Frame: 5 minutes before, 10 and 20 minutes during, and 5 minutes after intervention
|
Self-report survey: Physical Activity Affect Scale, negative affect subscale
|
5 minutes before, 10 and 20 minutes during, and 5 minutes after intervention
|
|
Tranquility as measured by Physical Activity Affect Scale
Time Frame: 5 minutes before, 10 and 20 minutes during, and 5 minutes after intervention
|
Self-report survey: Physical Activity Affect Scale, tranquility subscale
|
5 minutes before, 10 and 20 minutes during, and 5 minutes after intervention
|
|
Fatigue as measured by Physical Activity Affect Scale
Time Frame: 5 minutes before, 10 and 20 minutes during, and 5 minutes after intervention
|
Self-report survey: Physical Activity Affect Scale, fatigue subscale
|
5 minutes before, 10 and 20 minutes during, and 5 minutes after intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bethany Kwan, PhD, University of Colorado School of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- F31MH079636 (U.S. NIH Grant/Contract)
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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