Clinical trial NCT02560792: Tailored Activity Goals - an Exercise Prescription Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Affect
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2015-09-25
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Days of exercise according to prescription as measured by exercise log
timeFrame: 7 days
measure: Days of exercise according to prescription as measured by heart rate monitor
timeFrame: 7 days
Secondary outcomes:
measure: Intentions to exercise according to prescription as measured by intention to exercise scale
timeFrame: 5 minutes post-intervention
measure: Volitional control of exercise: Planning as measured by exercise planning scale
timeFrame: 7 days post-intervention
measure: Volitional control of exercise: Commitment as measured by commitment to exercise scale
timeFrame: 7 days post-intervention
Other outcomes:
measure: Positive activated affect as measured by Physical Activity Affect Scale
timeFrame: 5 minutes before, 10 and 20 minutes during, and 5 minutes after intervention
measure: Negative activated affect as measured by Physical Activity Affect Scale
timeFrame: 5 minutes before, 10 and 20 minutes during, and 5 minutes after intervention
measure: Tranquility as measured by Physical Activity Affect Scale
timeFrame: 5 minutes before, 10 and 20 minutes during, and 5 minutes after intervention
measure: Fatigue as measured by Physical Activity Affect Scale
timeFrame: 5 minutes before, 10 and 20 minutes during, and 5 minutes after intervention
Locations:
Study officials:
affiliation: University of Colorado School of Medicine
name: Bethany Kwan, PhD
role: PRINCIPAL_INVESTIGATOR
References: