Cognitive Performance During Physical ActivityCIMNCT02927275
Cognition in Motion
A study testing Experimental: Standing Modality, Experimental: Biking Modality and Experimental: Walking Modality in people with Cognitive Performance During Physical Activity, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of low-intensity exercise on cognitive functioning during activity. Evaluation was accomplished by having participants perform standardized cognitive tests while in three forms of low-intensity exercise and then comparing results to performance when sitting. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cognitive Performance During Physical Activity
- What is being tested?
- Experimental: Standing Modality, Experimental: Biking Modality and Experimental: Walking Modality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Student at Baylor College of Medicine
- Able to perform low-intensity exercise
Who cannot join
- Not a student at Baylor College of Medicine
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine-Department of Obstetrics & Gynecology
Houston, Texas, 77030
About this study
Official title: Cognition in Motion: Attitudes, Utilization, and Cognitive Impact of Low Intensity Exercise Among Medical Students
The purpose of this study is to evaluate the effect of low-intensity exercise on cognitive functioning during activity. Evaluation was accomplished by having participants perform standardized cognitive tests while in three forms of low-intensity exercise and then comparing results to performance when sitting.
Read the detailed description
While studies have demonstrated the beneficial effects of exercise, even when low-intensity, on physical health, investigations into cognitive performance during these periods of activity are increasing in number. For changes in the workplace to occur, data needs to show that mental processing is not compromised while engaging in low-intensity exercise.
In this current study, participants, after giving written consent, performed quantitative, computer-based cognitive tests to evaluate for differences in performance between active and sedentary conditions. The participants engaged in four activity modalities: sitting, standing, biking slowly on a stationary bicycle, and walking at 1mph. The validated tests used were immediate and delayed verbal recall, the color-word test based on the Stroop test, and the "n-back" test. Responses were scored according to both the speed in answering along with accuracy on each test. From the scores generated, effect sizes were calculated for sitting and compared to effect sizes for cumulative activity stations for statistical analysis.
- Being tested
- Experimental: Standing Modality, Experimental: Biking Modality, Experimental: Walking Modality, No Intervention: Seated Modality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Standing ModalityBehavioural
Cognitive performance when standing
Experimental: Biking ModalityBehavioural
Cognitive performance when biking slowly
Experimental: Walking ModalityBehavioural
Cognitive performance when walking at 1mph
No Intervention: Seated ModalityBehavioural
Cognitive performance when sitting.
| Study group | Role | What they receive |
|---|---|---|
| Standing Modality | Experimental | Performance on computerized cognitive tests while standing at a desk. Experimental: Standing Modality Receives: Behavioral: Experimental: Standing Modality |
| Biking Modality | Experimental | Performance on computerized cognitive tests while biking at user's preferred speed on stationary bicycle. Experimental: Biking Modality Receives: Behavioral: Experimental: Biking Modality |
| Walking Modality | Experimental | Performance on computerized cognitive tests while walking at 1mph. Experimental: Walking Modality Receives: Behavioral: Experimental: Walking Modality |
| Seated Modality | Other | Performance on computerized cognitive tests while sitting. No Intervention: Seated Modality Receives: Behavioral: No Intervention: Seated Modality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Testing Performance
Scores generated from cognitive testing
Measured: Starting in April 2012, participant enrollment was open for 41 months with data collection occurring immediately at the time of testing with no need for follow-up outcome measurements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startApr 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Cognitive Performance During Physical ActivityStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecilia Valdes, Baylor College of Medicine
- Investigators
- Cecilia T Valdes, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927275
- Sponsor's protocol ID
- H-31608
- Acronym
- CIM
- Status last verified
- Oct 2016
- First submitted
- 1 Oct 2016
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual performance on testing rounds was incorporated into cumulative statistical analysis and will not be made public.
Publications
Ogden CL, Carroll MD, Fryar CD, Flegal KM. Prevalence of Obesity Among Adults and Youth: United States, 2011-2014. NCHS Data Brief. 2015 Nov;(219):1-8.
PubMed 26633046Centers for Disease Control and Prevention (CDC). Prevalence of regular physical activity among adults--United States, 2001 and 2005. MMWR Morb Mortal Wkly Rep. 2007 Nov 23;56(46):1209-12.
PubMed 18030281U.S. Department of Health and Human Services. 2008 physical activity guidelines for Americans. 2008; http://health.gov/PAGuidelines/pdf/paguide.pdf. Accessed May 22, 2016.
Haskell WL. Physical activity by self-report: a brief history and future issues. J Phys Act Health. 2012 Jan;9 Suppl 1:S5-10. doi: 10.1123/jpah.9.s1.s5.
PubMed 22287448Bey L, Hamilton MT. Suppression of skeletal muscle lipoprotein lipase activity during physical inactivity: a molecular reason to maintain daily low-intensity activity. J Physiol. 2003 Sep 1;551(Pt 2):673-82. doi: 10.1113/jphysiol.2003.045591. Epub 2003 Jun 18.
PubMed 12815182van der Berg JD, Stehouwer CD, Bosma H, van der Velde JH, Willems PJ, Savelberg HH, Schram MT, Sep SJ, van der Kallen CJ, Henry RM, Dagnelie PC, Schaper NC, Koster A. Associations of total amount and patterns of sedentary behaviour with type 2 diabetes and the metabolic syndrome: The Maastricht Study. Diabetologia. 2016 Apr;59(4):709-18. doi: 10.1007/s00125-015-3861-8. Epub 2016 Feb 2.
PubMed 26831300Dunstan DW, Salmon J, Owen N, Armstrong T, Zimmet PZ, Welborn TA, Cameron AJ, Dwyer T, Jolley D, Shaw JE; AusDiab Steering Committee. Associations of TV viewing and physical activity with the metabolic syndrome in Australian adults. Diabetologia. 2005 Nov;48(11):2254-61. doi: 10.1007/s00125-005-1963-4. Epub 2005 Oct 7.
PubMed 16211373Wilmot EG, Edwardson CL, Achana FA, Davies MJ, Gorely T, Gray LJ, Khunti K, Yates T, Biddle SJ. Sedentary time in adults and the association with diabetes, cardiovascular disease and death: systematic review and meta-analysis. Diabetologia. 2012 Nov;55(11):2895-905. doi: 10.1007/s00125-012-2677-z. Epub 2012 Aug 14.
PubMed 22890825Wennberg P, Boraxbekk CJ, Wheeler M, Howard B, Dempsey PC, Lambert G, Eikelis N, Larsen R, Sethi P, Occleston J, Hernestal-Boman J, Ellis KA, Owen N, Dunstan DW. Acute effects of breaking up prolonged sitting on fatigue and cognition: a pilot study. BMJ Open. 2016 Feb 26;6(2):e009630. doi: 10.1136/bmjopen-2015-009630.
PubMed 26920441Reiff C, Marlatt K, Dengel DR. Difference in caloric expenditure in sitting versus standing desks. J Phys Act Health. 2012 Sep;9(7):1009-11. doi: 10.1123/jpah.9.7.1009.
PubMed 22971879Cox RH, Guth J, Siekemeyer L, Kellems B, Brehm SB, Ohlinger CM. Metabolic cost and speech quality while using an active workstation. J Phys Act Health. 2011 Mar;8(3):332-9. doi: 10.1123/jpah.8.3.332.
PubMed 21487132Dunstan DW, Kingwell BA, Larsen R, Healy GN, Cerin E, Hamilton MT, Shaw JE, Bertovic DA, Zimmet PZ, Salmon J, Owen N. Breaking up prolonged sitting reduces postprandial glucose and insulin responses. Diabetes Care. 2012 May;35(5):976-83. doi: 10.2337/dc11-1931. Epub 2012 Feb 28.
PubMed 22374636LeBlanc AG, Spence JC, Carson V, Connor Gorber S, Dillman C, Janssen I, Kho ME, Stearns JA, Timmons BW, Tremblay MS. Systematic review of sedentary behaviour and health indicators in the early years (aged 0-4 years). Appl Physiol Nutr Metab. 2012 Aug;37(4):753-72. doi: 10.1139/h2012-063.
PubMed 22765839Buckley JP, Hedge A, Yates T, Copeland RJ, Loosemore M, Hamer M, Bradley G, Dunstan DW. The sedentary office: an expert statement on the growing case for change towards better health and productivity. Br J Sports Med. 2015 Nov;49(21):1357-62. doi: 10.1136/bjsports-2015-094618. Epub 2015 Jun 1.
PubMed 26034192Francois ME, Baldi JC, Manning PJ, Lucas SJ, Hawley JA, Williams MJ, Cotter JD. 'Exercise snacks' before meals: a novel strategy to improve glycaemic control in individuals with insulin resistance. Diabetologia. 2014 Jul;57(7):1437-45. doi: 10.1007/s00125-014-3244-6. Epub 2014 May 10.
PubMed 24817675
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition in Motion: Attitudes, Utilization, and Cognitive Impact of Low Intensity Exercise Among Medical Students
- ClinicalTrials.gov ID
- NCT02927275
- Acronym / sponsor ID
- CIM / H-31608
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of low-intensity exercise on cognitive functioning during activity. Evaluation was accomplished by having participants perform standardized cognitive tests while in three forms of low-intensity exercise and then comparing results to performance when sitting.
Detailed description
While studies have demonstrated the beneficial effects of exercise, even when low-intensity, on physical health, investigations into cognitive performance during these periods of activity are increasing in number. For changes in the workplace to occur, data needs to show that mental processing is not compromised while engaging in low-intensity exercise.
In this current study, participants, after giving written consent, performed quantitative, computer-based cognitive tests to evaluate for differences in performance between active and sedentary conditions. The participants engaged in four activity modalities: sitting, standing, biking slowly on a stationary bicycle, and walking at 1mph. The validated tests used were immediate and delayed verbal recall, the color-word test based on the Stroop test, and the "n-back" test. Responses were scored according to both the speed in answering along with accuracy on each test. From the scores generated, effect sizes were calculated for sitting and compared to effect sizes for cumulative activity stations for statistical analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standing Modality | Experimental | Behavioral: Experimental: Standing ModalityPerformance on computerized cognitive tests while standing at a desk. Experimental: Standing Modality |
| Biking Modality | Experimental | Behavioral: Experimental: Biking ModalityPerformance on computerized cognitive tests while biking at user's preferred speed on stationary bicycle. Experimental: Biking Modality |
| Walking Modality | Experimental | Behavioral: Experimental: Walking ModalityPerformance on computerized cognitive tests while walking at 1mph. Experimental: Walking Modality |
| Seated Modality | Other | Behavioral: No Intervention: Seated ModalityPerformance on computerized cognitive tests while sitting. No Intervention: Seated Modality |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Student at Baylor College of Medicine
- Able to perform low-intensity exercise
Key exclusion criteria (1 listed)
- Not a student at Baylor College of Medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Standing ModalityCognitive performance when standing | Behavioural | Standing Modality |
| Experimental: Biking ModalityCognitive performance when biking slowly | Behavioural | Biking Modality |
| Experimental: Walking ModalityCognitive performance when walking at 1mph | Behavioural | Walking Modality |
| No Intervention: Seated ModalityCognitive performance when sitting. | Behavioural | Seated Modality |
Primary outcome
Cognitive Testing Performance
Time frame: Starting in April 2012, participant enrollment was open for 41 months with data collection occurring immediately at the time of testing with no need for follow-up outcome measurements.
Scores generated from cognitive testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Background: PubMed 26633046Ogden CL, Carroll MD, Fryar CD, Flegal KM. Prevalence of Obesity Among Adults and Youth: United States, 2011-2014. NCHS Data Brief. 2015 Nov;(219):1-8.
- Background: PubMed 18030281Centers for Disease Control and Prevention (CDC). Prevalence of regular physical activity among adults--United States, 2001 and 2005. MMWR Morb Mortal Wkly Rep. 2007 Nov 23;56(46):1209-12.
- BackgroundU.S. Department of Health and Human Services. 2008 physical activity guidelines for Americans. 2008; http://health.gov/PAGuidelines/pdf/paguide.pdf. Accessed May 22, 2016.
- Background: PubMed 22287448Haskell WL. Physical activity by self-report: a brief history and future issues. J Phys Act Health. 2012 Jan;9 Suppl 1:S5-10. doi: 10.1123/jpah.9.s1.s5.
- Background: PubMed 12815182Bey L, Hamilton MT. Suppression of skeletal muscle lipoprotein lipase activity during physical inactivity: a molecular reason to maintain daily low-intensity activity. J Physiol. 2003 Sep 1;551(Pt 2):673-82. doi: 10.1113/jphysiol.2003.045591. Epub 2003 Jun 18.
- Background: PubMed 26831300van der Berg JD, Stehouwer CD, Bosma H, van der Velde JH, Willems PJ, Savelberg HH, Schram MT, Sep SJ, van der Kallen CJ, Henry RM, Dagnelie PC, Schaper NC, Koster A. Associations of total amount and patterns of sedentary behaviour with type 2 diabetes and the metabolic syndrome: The Maastricht Study. Diabetologia. 2016 Apr;59(4):709-18. doi: 10.1007/s00125-015-3861-8. Epub 2016 Feb 2.
- Background: PubMed 16211373Dunstan DW, Salmon J, Owen N, Armstrong T, Zimmet PZ, Welborn TA, Cameron AJ, Dwyer T, Jolley D, Shaw JE; AusDiab Steering Committee. Associations of TV viewing and physical activity with the metabolic syndrome in Australian adults. Diabetologia. 2005 Nov;48(11):2254-61. doi: 10.1007/s00125-005-1963-4. Epub 2005 Oct 7.
- Background: PubMed 22890825Wilmot EG, Edwardson CL, Achana FA, Davies MJ, Gorely T, Gray LJ, Khunti K, Yates T, Biddle SJ. Sedentary time in adults and the association with diabetes, cardiovascular disease and death: systematic review and meta-analysis. Diabetologia. 2012 Nov;55(11):2895-905. doi: 10.1007/s00125-012-2677-z. Epub 2012 Aug 14.
- Background: PubMed 26920441Wennberg P, Boraxbekk CJ, Wheeler M, Howard B, Dempsey PC, Lambert G, Eikelis N, Larsen R, Sethi P, Occleston J, Hernestal-Boman J, Ellis KA, Owen N, Dunstan DW. Acute effects of breaking up prolonged sitting on fatigue and cognition: a pilot study. BMJ Open. 2016 Feb 26;6(2):e009630. doi: 10.1136/bmjopen-2015-009630.
- Background: PubMed 22971879Reiff C, Marlatt K, Dengel DR. Difference in caloric expenditure in sitting versus standing desks. J Phys Act Health. 2012 Sep;9(7):1009-11. doi: 10.1123/jpah.9.7.1009.
- Background: PubMed 21487132Cox RH, Guth J, Siekemeyer L, Kellems B, Brehm SB, Ohlinger CM. Metabolic cost and speech quality while using an active workstation. J Phys Act Health. 2011 Mar;8(3):332-9. doi: 10.1123/jpah.8.3.332.
- Background: PubMed 22374636Dunstan DW, Kingwell BA, Larsen R, Healy GN, Cerin E, Hamilton MT, Shaw JE, Bertovic DA, Zimmet PZ, Salmon J, Owen N. Breaking up prolonged sitting reduces postprandial glucose and insulin responses. Diabetes Care. 2012 May;35(5):976-83. doi: 10.2337/dc11-1931. Epub 2012 Feb 28.
- Individual participant dataSharing planned: No. Individual performance on testing rounds was incorporated into cumulative statistical analysis and will not be made public.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilia T Valdes, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Standing Modality, Experimental: Biking Modality and Experimental: Walking Modality in people with Cognitive Performance During Physical Activity, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Testing Performance (time frame: Starting in April 2012, participant enrollment was open for 41 months with data collection occurring immediately at the time of testing with no need for follow-up outcome measurements.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02927275, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016.