NCT02717377

Brief Summary

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. 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. 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.
  3. 3.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.
  4. 4.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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

February 22, 2016

Last Update Submit

March 17, 2016

Conditions

Keywords

Micro boutsPhysical Activity

Outcome Measures

Primary Outcomes (3)

  • Change in Energy and Mood level

    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

    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

    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

Study Arms (3)

Uninterrupted sitting

NO INTERVENTION

Subjects remained seated all day except to rise from the chair to void.

Sitting + one bout of activity

ACTIVE COMPARATOR

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

Sitting + microbursts of activity

EXPERIMENTAL

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

Interventions

Sitting + microbursts of activitySitting + one bout of activity

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bergouignan A, Legget KT, De Jong N, Kealey E, Nikolovski J, Groppel JL, Jordan C, O'Day R, Hill JO, Bessesen DH. Effect of frequent interruptions of prolonged sitting on self-perceived levels of energy, mood, food cravings and cognitive function. Int J Behav Nutr Phys Act. 2016 Nov 3;13(1):113. doi: 10.1186/s12966-016-0437-z.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • James Hill

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 23, 2016

Study Start

November 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

March 23, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

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.