Tailored Activity Goals - an Exercise Prescription Study (TAG)

September 24, 2015 updated by: University of Colorado, Boulder
The primary goal of this study is to determine experimentally the relationship between affective response to exercise and future exercise behavior. A secondary goal is to examine potential mediators and moderators of this relationship, specifically four variables considered to contribute to the volitional control of exercise behavior - planning, attention, resource commitment, and affect regulation. An additional goal is to examine how symptoms of depression might influence the affective response to exercise, and the relationship between affective response to exercise and exercise behavior.

Study Overview

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

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

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: 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bethany Kwan, PhD, University of Colorado School of Medicine

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

September 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

September 24, 2015

First Posted (Estimate)

September 25, 2015

Study Record Updates

Last Update Posted (Estimate)

September 25, 2015

Last Update Submitted That Met QC Criteria

September 24, 2015

Last Verified

September 1, 2015

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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