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Completed

NCT Number: NCT02560792

Tailored Activity Goals - an Exercise Prescription Study

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive Affect Condition

Behavioral

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."

Negative Affect Condition

Behavioral

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."

Control condition

Behavioral

Participants receive no information about affective response

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. Volitional control of exercise: Planning as measured by exercise planning scale

    Time frame: 7 days post-intervention

    Self-report survey: exercise planning scale

  3. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: TAG

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 25, 2015
Registry last updated
Sep 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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