- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03162978
Sprint to Fitness: Effect of Outcome Expectations on Responses to Interval Exercise Training
January 23, 2022 updated by: James Roemmich, USDA Grand Forks Human Nutrition Research Center
Effect of Outcome Expectations on Psychological and Physiological Responses to Interval Exercise Training
The purpose of this study is to research the effects of exercising at high intensities for short periods of time on exercise tolerance and motivation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The proposed research will investigate whether adding a treatment component that focuses on positive outcome expectations of a high-intensity interval training (HIIT) intervention produces greater improvements in psychological and physiological study outcomes.
This project will yield empirical evidence that will inform how to help Americans meet physical activity guidelines; how to develop exercise programs that are more likely to promote exercise as a habit; and maintenance of health and a healthy body weight.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Dakota
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Grand Forks, North Dakota, United States, 58203
- USDA Grand Forks Human Nutrition Research Center
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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 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Body Mass Index of 25-35 kg/m2
- Sedentary (not regularly engaging in exercise more than once per week)
- Weight stable (have not lost or gained over 10 pounds of body weight in the past 3 months)
Exclusion Criteria:
- Taking any medications that affect energy expenditure or treat high blood pressure
- Tobacco use
- Pregnant or breastfeeding or plan to become pregnant in the next 3 months
- Have any medical conditions that prevent subject from safely exercising (e.g., orthopedic injuries, cardiovascular, liver, endocrine, or pulmonary diseases)
- Resting systolic blood pressure ≥ 140 mmHg
- Resting diastolic blood pressure ≥ 90 mmHg
- Non-fasting plasma glucose of ≥ 200 mg/dl
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HIIT + POE
High-intensity interval training (HIIT) plus positive outcome expectations (POE) from participating in the exercise program.
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Subjects will participate in high-intensity interval training (HIIT) with an additional treatment component to increase positive outcome expectations (POE) of exercise.
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Experimental: HIIT only
High-intensity interval training (HIIT) only.
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Subjects will participate in high-intensity interval training (HIIT) only.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in relative reinforcing value (RRV) of physical activity
Time Frame: Week 0, Week 6, Week 10
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RRV of physical activity will be assessed by evaluating the number of responses (mouse button presses) a subject is willing to complete to gain access to physical activity or a sedentary alternative.
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Week 0, Week 6, Week 10
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Changes in preference for intense physical activity and tolerance for exercise discomfort
Time Frame: Week 0, Week 6, Week 10
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Changes in preference for intense physical activity and tolerance for exercise discomfort will be assessed by self-report questionnaire responses to the Preference for and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q).
The PRETIE-Q measures preference for high intensity vs. low intensity exercise and ability to persist or tolerate the discomfort associationed with intense exercise.
The PRETIE-Q consists of two subscales: Preference for Exercise Intensity and Tolerance of Exercise Intensity.
Each subscale has 8 items rated on a 5 point response scale (range 8 - 40).
Higher scores indicate greater preference for intense exercise and/or greater tolerance for exercise discomfort.
Total scale scores are not used.
Scale averages will be used.
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Week 0, Week 6, Week 10
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in minutes of physical activity, as assessed by activity tracker
Time Frame: Week 0, Week 6, Week 10
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Minutes of physical activity will be assessed by having participants wear an Actigraph accelerometer for 7 days (minimum 10 hours per day) on the right hip.
|
Week 0, Week 6, Week 10
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Changes in quadriceps and hamstring (thigh muscle) strength assessed separately on each leg
Time Frame: Week 0, Week 6, Week 10
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After range of motion is determined, participants will engage in a series of extensions and flexions in which maximum velocity is set at 60°, 180°, and 300°.s±1 to determine each leg's peak torque as assessed by isokinetic dynamometer testing (Biodex System 4 Pro).
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Week 0, Week 6, Week 10
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Changes in aerobic fitness, as assessed using the Standardized Exponential Exercise Protocol (STEEP)
Time Frame: Week 0, Week 6, Week 10
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After a brief warm-up, participants will pedal on an ergometer 75-85 revolutions per minute (RPMs) at low resistance of approximately 2 metabolic equivalent of task (METs).
The resistance will increase by 15% per minute until respiratory exchange ratio (RER) exceeds 1.0, maximum oxygen consumption (V02 max) is reached, or participant can no longer maintain pedaling speed.
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Week 0, Week 6, Week 10
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Changes in anaerobic power, as during a Wingate anaerobic power exercise test
Time Frame: Week 0, Week 6, Week 10
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Following a brief warm-up, participants will be instructed to pedal on an ergometer as hard and as fast as they can for 30 seconds at a resistance of 1 watt·kilogram-1, followed by a cool-down period.
Changes in anaerobic power, will be as assessed by as changes in power outputs in watts (rpm·braking force).
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Week 0, Week 6, Week 10
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Changes in fat mass as assessed by dual energy x-ray absorptiometry (DXA) scans
Time Frame: Week 0, Week 6, Week 10
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Participants will be instructed to lie supine with hands by their sides on a GE Lunar iDXA machine for a full-body x-ray scan which will measure grams and percentage changed in fat mass.
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Week 0, Week 6, Week 10
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Changes in fat-free lean mass as assessed by DXA scans
Time Frame: Week 0, Week 6, Week 10
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Participants will be instructed to lie supine with hands by their sides on a GE Lunar iDXA machine for a full-body x-ray scan which will measure grams and percentage changed in fat-free lean mass.
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Week 0, Week 6, Week 10
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Changes in tolerance for physical pain and discomfort
Time Frame: Week 0, Week 6, Week 10
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Changes in preference for tolerance for physical pain and discomfort will be assessed by self-report questionnaire responses to the Discomfort Intolerance Scale (DIS).
This scale measures individual differences in ability to tolerate uncomfortable sensations.
There are 7 items total.
Although there are two subscales (measure ability to tolerate discomfort / pain and avoidance of physical discomfort) only total scores will be used.
There are 7 items total.
Items are scored 0 - 6 (total range 0 - 42), with higher scores indicating greater ability to tolerate physical discomfort.
Average score on the total scale will be used.
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Week 0, Week 6, Week 10
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Changes in perceived support for physical activity from friends and family members
Time Frame: Week 0, Week 6, Week 10
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Changes perceived support for physical activity from friends and family members will be assessed by self-report questionnaire responses to the Social Support and Exercise Survey.
This questionnaire measures 13 items are scored on a scale of 1 - 5, with higher scores indicating greater perceived support.
Total scores will be used, with ranges from 13 - 65. Higher scores indicate greater perceived support.
Average score for the total scale will be used.
Items may be answered twice, once for family members and once for friends.
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Week 0, Week 6, Week 10
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Changes in perceptions of how much exercise satisfies autonomy, relatedness, and competence needs
Time Frame: Week 0, Week 6, Week 10
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Changes in perceptions of how much exercise satisfies autonomy, relatedness, and competence needs will be assessed by self-report questionnaire responses to the Psychological Need Satisfaction in Exercise Scale.
This scale measures how much the psychological needs of autonomy, relatedness, and competence are satisfied during exercise.
There are three subscales: autonomy, relatedness, and competence.
Each subscale has 6 items rated on a 6-point scale.
Higher scores indicate greater amounts of the construct.
Total subscale scores may range from 6 to 36.
Subscale averages will be used in analyses.
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Week 0, Week 6, Week 10
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Changes in intrinsic, external, interrogated, identified, introjected and amotivation for physical activity
Time Frame: Week 0, Week 6, Week 10
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Changes in intrinsic, external, interrogated, identified, introjected and amotivation for physical activity will be assessed by self-report questionnaire responses to the Behavioral Regulation in Exercise, 3rd Edition (BREQ-3).This scale measures how much exercise behavior is driven by intrinsic motivation, external motivation, interrogated motivation, identified motivation, introjected motivation, and amotivation (lack of motivation).
There are 6 subscales with 4 items each: intrinsic, external, interrogated, identified, introjected, and amotivation.
Items are measured on a 5-point scale, where higher scores indicated greater amounts of the construct.
Subscale scores may range from 4 to 20.
Average subscale scores will be used in analyses.
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Week 0, Week 6, Week 10
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Changes in how enjoyable physical activity is perceived to be
Time Frame: Week 0, Week 6, Week 10
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Changes in how enjoyable physical activity is perceived to be will be assessed by self-report questionnaire responses to the Physical Activity Enjoyment scale (PACES).
This scale measures how enjoyable or unenjoyable physical activity is perceived to be.
The measure consists of 18 questions and no subscales.
Each question is measured on a 7-point scale, where higher scores indicate greater enjoyment.
Total scores may range from 18 to 126.
Average score will be used.
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Week 0, Week 6, Week 10
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Changes in perceived effort expended during exercise
Time Frame: Week 0, Week 6, Week 10
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Changes in perceived effort expended during exercise will be assessed by self-report questionnaire responses to the Borg Rating of Perceived Exertion Scale.
This scale measures perceived physical exertion during exercise.
There is only 1 item and no subscales.
Scores may range from 0 to 10, with higher scores indicating greater perceived exertion.
The total score will be used in analyses.
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Week 0, Week 6, Week 10
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Changes in perceived pain/discomfort during exercise
Time Frame: Week 0, Week 6, Week 10
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Changes in perceived pain/discomfort during exercise will be assessed by self-report questionnaire responses to the Numeric Ratings Pain Scale.
This single item scale measures muscle pain/discomfort associated with physical activity.
There are no subscales.
Scores may range from 0 to 11, with higher scores indicating greater pain/discomfort.
The total score will be used in analyses.
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Week 0, Week 6, Week 10
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Changes in perceived ability to continue exercise long-term
Time Frame: Week 0, Week 6, Week 10
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Changes in perceived ability to continue exercise long-term will be assessed by self-report questionnaire responses to the Barriers Self-Efficacy Scale (BARSE).
This scale measures perceived ability to continue meeting exercise guidelines over the next 1 to 8 weeks.
There are no subscales.
8 items are measured on an 11-point scale where higher scores indicate greater certainty in ability to complete exercise.
Average score will be used in analyses.
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Week 0, Week 6, Week 10
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Changes in perceived ability to stick to an exercise routine
Time Frame: Week 0, Week 6, Week 10
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Changes in perceived ability to stick to an exercise routine will be assessed by self-report questionnaire responses to the Exercise Confidence Survey.
This scale measures perceived confidence in ability to make time for exercise and persist in an exercise routine.
There are 2 subscales: sticking to it (8 items) and making time for exercise (4 items).
Items are measured on a 5-point scale where higher scores indicate greater confidence.
Total scores may range from 8-40 (sticking to it) or 4-20 (making time).
Average subscale scores will be used in analyses.
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Week 0, Week 6, Week 10
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: James N Roemmich, PhD, USDA Grand Forks Human Nutrition Research Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
November 29, 2017
Primary Completion (Actual)
October 21, 2019
Study Completion (Actual)
October 21, 2019
Study Registration Dates
First Submitted
May 19, 2017
First Submitted That Met QC Criteria
May 19, 2017
First Posted (Actual)
May 22, 2017
Study Record Updates
Last Update Posted (Actual)
February 7, 2022
Last Update Submitted That Met QC Criteria
January 23, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GFHNRC407
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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