- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02717377
Effect of Frequent Interruptions of Prolonged Sitting on Self-perceived Levels of Energy, Mood, Food Cravings and Cognitive Function
This study is designed to test the effects of six 5 minute microbursts of physical activity spread across the day as compared to either a sedentary control condition or a single 30 minute bout of moderate intensity physical activity on cognitive function, self-reported energy levels, aspects of eating behavior and measures of metabolic health. The primary hypotheses are:
- Hourly 5 minute bouts of moderate intensity exercise during the day will increase afternoon cognitive function as compared to a no exercise condition.
- Hourly 5 minute bouts of moderate intensity exercise during the day will increase afternoon cognitive function more than a single 30 minute AM bout.
Secondary exploratory hypotheses include
- Hourly 5 minute bouts of moderate intensity exercise during the day will increase self-reported energy levels, reduce orexigenic appetitive measures and improve measures of metabolic health as compared to a no exercise condition.
- Hourly 5 minute bouts of moderate intensity exercise during the day will increase self-reported energy levels, reduce orexigenic appetitive measures and improve measures of metabolic health more than a single 30 minute AM bout.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All ethnic groups and both genders
- Age: Lower age limit: 19 years; Upper age limit: 45 years
- Body-mass Index: Lower BMI limit: 18.5 kg/m2; Upper BMI limit: 29.9 kg/m2
- Willing to adhere to caffeine restrictions of no more than two 16 ounce beverages in the morning of each study day with no caffeine intake after 12:00pm on any of the three study days
Exclusion Criteria:
- History of cardiovascular disease, including coronary artery disease, congestive heart failure, & unstable angina, or uncontrolled hypertension (>140/90 mm Hg)
- Currently smoking or stopped smoking in the last 6 months
- Medications affecting weight, energy intake, or energy expenditure in the last 6 months
- Use of oral steroids
- History of stroke or seizures, thyroid disease, type 1 or 2 diabetes, Cushing's syndrome, cerebrovascular, renal disease, hepatic disease, arrhythmias
- Cancer requiring treatment in the past 5 years, with the exception of skin cancers other than melanoma
- Infectious diseases: Self-reported HIV positivity or active tuberculosis
- Inability to exercise for more than 30 minutes on a treadmill at moderate intensity
- Currently pregnant, lactating or less than 6 months post-partum
- History of a major psychiatric disorder including schizophrenia, bipolar illness or psychotic depression
- Score of >25 on Beck Depression Inventory
- No recreational drug use including marijuana in the past 1 year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Uninterrupted sitting
Subjects remained seated all day except to rise from the chair to void.
|
|
|
ACTIVE_COMPARATOR: Sitting + one bout of activity
Subjects remained seated all day, except to rise from the chair to void, and to perform one bout of 30-minutes moderate-intensity walking.
Physical activity was performed at 0800, after measures of vitals and basal questionnaire assessments, but before breakfast.
|
|
|
EXPERIMENTAL: Sitting + microbursts of activity
Subjects rose from the seated position every hour for 6-hours from 0910 to 1430 to complete 5-minute bouts of moderate-intensity walking, yielding a total activity time of 30-minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Energy and Mood level
Time Frame: During each of the three separate study days energy and mood levels are assessed at (in minutes): T0, T40, T70, T80, T90, T120, T140, T230, T350, T390, T400, T405, T410, and T435
|
Self-perceived energy and mood were measured by using visual analogue scales (VAS) as described below at baseline.
|
During each of the three separate study days energy and mood levels are assessed at (in minutes): T0, T40, T70, T80, T90, T120, T140, T230, T350, T390, T400, T405, T410, and T435
|
|
Change in Cognitive function
Time Frame: During each of the three separate study days cognitive function is measured at (in minutes): T410
|
The flanker task is used to measure cognitive function
|
During each of the three separate study days cognitive function is measured at (in minutes): T410
|
|
Change in Cognitive Function
Time Frame: During each of the three separate study days cognitive function is measured at (in minutes): T425
|
After the Flanker task, the Comprehensive Trail Making Test is used to measure cognitive function during each study day.
|
During each of the three separate study days cognitive function is measured at (in minutes): T425
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Hill, University of Colorado, Denver
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 13-2777
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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