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Acute Effects of Sitting and Physical Activity on Brain Health

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04137211
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Collaborators:
The Knowledge Foundation
ICA-gruppen
Intrum AB
SATS
Monark Exercise
Itrim
Information provided by (Responsible Party):
Maria Ekblom, The Swedish School of Sport and Health Sciences

Brief Summary:
The specific aim of this study is to understand how a working day composed of prolonged sitting, sitting regularly interrupted by light aerobic exercise or resistance exercise affects an important mechanism underpinning healthy brain functions, namely cerebral blood flow. It is primarily focused on investigating these effects in ecologically valid conditions, i.e. activity patterns that closely resemble a typical day at the office.

Condition or disease Intervention/treatment Phase
Healthy Adults Behavioral: Prolonged sitting with social break Behavioral: Prolonged sitting with walk break Behavioral: Prolonged sitting with simple resistance activities Not Applicable

Detailed Description:
The study will be a controlled crossover experimental trial with three conditions involving 26 adult participants aged between 40 and 60 years. Each participant will complete each of the three experimental conditions, separated by a washout period of minimum four days. As well, physical activity behaviours and sleep the day/night before the test day will be measured. The first visit will be a familiarization session. On the second, third, and fourth visits, participants will undergo three different standardized 3-hour interventions in a randomized order. Before and immediately after the three-hour interventions, blood pressure, augmentation index, and cerebral hemodynamic response of the prefrontal cortex during standardized cognitive tasks (1,2, and 3-back tests) will be measured. Additionally, saliva samples will be collected the morning of the test day and before and after the interventions, blood glucose will be assessed continuously during the trial, and fitness will be measured at the familiarization visit.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Acute Effects of Sitting and Physical Activity on Cerebrovascular Circulation Among Adults
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: Prolonged sitting with social break Behavioral: Prolonged sitting with social break
Participants are required to sit for three hours (reading is permitted), with a toilet break in between. Every thirty minutes participants will have a short social break. Test day begins at 7:30 with pretest measures, followed by the intervention at about 9:00, which will end around 12:00, with subsequent posttest measures.

Experimental: Prolonged sitting with walk break Behavioral: Prolonged sitting with walk break
Participants are required to sit for three hours (reading is permitted), with a toilet break in between. Every thirty minutes participants will have a physical activity break, where they will perform a brisk walk for about three minutes on a treadmill at a predetermined speed and grade based on the fitness test performed during the familiarization session. Test day begins at 7:30 with pretest measures, followed by the intervention at about 9:00, which will end around 12:00, with subsequent posttest measures.

Experimental: Prolonged sitting with simple resistance activities Behavioral: Prolonged sitting with simple resistance activities
Participants are required to sit for three hours (reading is permitted), with a toilet break in between. Every thirty minutes participants will have a physical activity break, where they will perform simple resistance activities following a video for about three minutes. Test day begins at 7:30 with pretest measures, followed by the intervention at about 9:00, which will end around 12:00, with subsequent posttest measures.




Primary Outcome Measures :
  1. Changes in cerebral blood flow [ Time Frame: before to after 3 hour intervention ]
    Oxygenated, deoxygenated, and total hemoglobin concentration changes measured with functional near-infrared spectroscopy


Secondary Outcome Measures :
  1. Augmentation index [ Time Frame: before to after 3 hour intervention ]
    as a measure of arterial stiffness

  2. Blood glucose levels [ Time Frame: during the 3 hour intervention ]
  3. Blood pressure [ Time Frame: before to after 3 hour intervention ]
    systolic and diastolic blood pressure; and pulse pressure

  4. Cortisol [ Time Frame: before to after 3 hour intervention ]
  5. Mood [ Time Frame: before to after 3 hour intervention ]
    measured with the Positive and Negative Affect Schedule (PANAS) comprised of 20 affect states (10 positive and 10 negative), each affect state scored on a scale going from 1 (very slightly or not at all) to 5 (extremely)

  6. Sleepiness [ Time Frame: before to after 3 hour intervention ]
    measured with Karolinska Sleepiness Questionnaire; goes from 1 (extremely alert) to 9 (extremely sleepy)

  7. Cognitive performance [ Time Frame: before to after 3 hour intervention ]
    nback cognitive test (time and accuracy)

  8. Alertness [ Time Frame: before to after 3 hour intervention ]
    measured with a Visual Analogue Scale (VAS)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- has a BMI under 35kg/m2

Exclusion Criteria:

  • Diabetes, epilepsy, or has experienced heart failure, stroke, or myocardial infarction
  • Takes treatment for sleep disorders, depression, or psychosis

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): NCT04137211


Contacts
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Contact: Örjan Ekblom, PhD +46 8 120 538 22 orjan.ekblom@gih.se

Locations
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Sweden
The Swedish School of Sport and Health Sciences (GIH) Recruiting
Stockholm, Sweden, 114 86
Contact: Örjan Ekblom, PhD    +46 8 120 538 22    orjan.ekblom@gih.se   
Sponsors and Collaborators
The Swedish School of Sport and Health Sciences
The Knowledge Foundation
ICA-gruppen
Intrum AB
SATS
Monark Exercise
Itrim
Investigators
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Principal Investigator: Maria Ekblom, PhD The Swedish School of Sport and Health Sciences (GIH)

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Responsible Party: Maria Ekblom, Associate Professor, The Swedish School of Sport and Health Sciences
ClinicalTrials.gov Identifier: NCT04137211    
Other Study ID Numbers: Dnr:2019-00998
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No