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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02560792
Other study ID # F31MH079636
Secondary ID F31MH079636
Status Completed
Phase N/A
First received July 30, 2015
Last updated September 24, 2015
Start date September 2009
Est. completion date February 2010

Study information

Verified date September 2015
Source University of Colorado, Boulder
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date February 2010
Est. primary completion date January 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
Positive Affect Condition
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
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
Participants receive no information about affective response

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Boulder National Institute of Mental Health (NIMH)

Outcome

Type Measure Description Time frame Safety issue
Other Positive activated affect as measured by Physical Activity Affect Scale Self-report survey: Physical Activity Affect Scale, positive affect subscale 5 minutes before, 10 and 20 minutes during, and 5 minutes after intervention No
Other Negative activated affect as measured by Physical Activity Affect Scale Self-report survey: Physical Activity Affect Scale, negative affect subscale 5 minutes before, 10 and 20 minutes during, and 5 minutes after intervention No
Other Tranquility as measured by Physical Activity Affect Scale Self-report survey: Physical Activity Affect Scale, tranquility subscale 5 minutes before, 10 and 20 minutes during, and 5 minutes after intervention No
Other Fatigue as measured by Physical Activity Affect Scale Self-report survey: Physical Activity Affect Scale, fatigue subscale 5 minutes before, 10 and 20 minutes during, and 5 minutes after intervention No
Primary Days of exercise according to prescription as measured by exercise log Number of days of prescribed exercise recorded on exercise log 7 days No
Primary Days of exercise according to prescription as measured by heart rate monitor Number of days of prescribed exercise recorded by heart rate monitor 7 days No
Secondary Intentions to exercise according to prescription as measured by intention to exercise scale Self-report survey: intention to exercise scale 5 minutes post-intervention No
Secondary Volitional control of exercise: Planning as measured by exercise planning scale Self-report survey: exercise planning scale 7 days post-intervention No
Secondary Volitional control of exercise: Commitment as measured by commitment to exercise scale Self-report survey: commitment to exercise scale 7 days post-intervention No
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