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Effect of Frequent Interruptions of Prolonged Sitting on Self-perceived Levels of Energy, Mood, Food Cravings and Cognitive Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02717377
First Posted: March 23, 2016
Last Update Posted: March 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose

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:

  1. Hourly 5 minute bouts of moderate intensity exercise during the day will increase afternoon cognitive function as compared to a no exercise condition.
  2. 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

  1. 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.
  2. 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.

Condition Intervention
Mood Energy Food Cravings Cognitive Function Behavioral: physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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.

  • 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

  • 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.


Enrollment: 30
Study Start Date: November 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: physical activity
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.
Behavioral: physical activity

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. All ethnic groups and both genders
  2. Age: Lower age limit: 19 years; Upper age limit: 45 years
  3. Body-mass Index: Lower BMI limit: 18.5 kg/m2; Upper BMI limit: 29.9 kg/m2
  4. 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:

  1. History of cardiovascular disease, including coronary artery disease, congestive heart failure, & unstable angina, or uncontrolled hypertension (>140/90 mm Hg)
  2. Currently smoking or stopped smoking in the last 6 months
  3. Medications affecting weight, energy intake, or energy expenditure in the last 6 months
  4. Use of oral steroids
  5. History of stroke or seizures, thyroid disease, type 1 or 2 diabetes, Cushing's syndrome, cerebrovascular, renal disease, hepatic disease, arrhythmias
  6. Cancer requiring treatment in the past 5 years, with the exception of skin cancers other than melanoma
  7. Infectious diseases: Self-reported HIV positivity or active tuberculosis
  8. Inability to exercise for more than 30 minutes on a treadmill at moderate intensity
  9. Currently pregnant, lactating or less than 6 months post-partum
  10. History of a major psychiatric disorder including schizophrenia, bipolar illness or psychotic depression
  11. Score of >25 on Beck Depression Inventory
  12. No recreational drug use including marijuana in the past 1 year
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717377


Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: James Hill University of Colorado, Denver
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02717377     History of Changes
Other Study ID Numbers: 13-2777
First Submitted: February 22, 2016
First Posted: March 23, 2016
Last Update Posted: March 23, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This clinical trial is a small study (n=30) that received limited funding from Johnson and Johnson Company, a non-public funding company. Our data sharing plan will follow the NIH guidelines for data sharing plans of small clinical trials and not unique set of data that could benefit the community (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm#901). Following the NIH definition of "the timely release and sharing" to be no later than the acceptance for publication of the main findings from the final data set, final research data will be shared through scientific publications after peer-review.

Keywords provided by University of Colorado, Denver:
Micro bouts
Physical Activity