- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04137211
Acute Effects of Sitting and Physical Activity on Brain Health
December 12, 2022 updated by: The Swedish School of Sport and Health Sciences
Acute Effects of Sitting and Physical Activity on Cerebrovascular Circulation Among Adults
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.
Study Overview
Status
Completed
Conditions
Detailed Description
The study will be a controlled crossover experimental trial with three conditions involving 13 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.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Stockholm, Sweden, 114 86
- The Swedish School of Sport and Health Sciences (GIH)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
36 years to 56 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Has a BMI under 35kg/m2
Exclusion Criteria:
- Has diabetes, epilepsy, or circulatory conditions
- Has experienced heart failure, stroke, or myocardial infarction
- Takes treatment for high blood pressure, sleep disorders, depression, or psychosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in cerebral blood flow
Time Frame: before to after 3 hour intervention
|
Oxygenated and deoxygenated hemoglobin concentration changes measured with functional near-infrared spectroscopy
|
before to after 3 hour intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Augmentation index
Time Frame: before to after 3 hour intervention
|
as a measure of arterial stiffness
|
before to after 3 hour intervention
|
|
Blood glucose levels
Time Frame: during the 3 hour intervention
|
during the 3 hour intervention
|
|
|
Cortisol
Time Frame: before to after 3 hour intervention
|
before to after 3 hour intervention
|
|
|
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)
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before to after 3 hour intervention
|
|
Sleepiness
Time Frame: before to after 3 hour intervention
|
measured with Karolinska Sleepiness Questionnaire; goes from 1 (extremely alert) to 9 (extremely sleepy)
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before to after 3 hour intervention
|
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Cognitive performance
Time Frame: before to after 3 hour intervention
|
nback cognitive test (time and accuracy)
|
before to after 3 hour intervention
|
|
Alertness
Time Frame: before to after 3 hour intervention
|
measured with a Visual Analogue Scale (VAS)
|
before to after 3 hour intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Maria Ekblom, PhD, The Swedish School of Sport and Health Sciences (GIH)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 13, 2019
Primary Completion (Actual)
March 13, 2020
Study Completion (Actual)
March 13, 2020
Study Registration Dates
First Submitted
October 15, 2019
First Submitted That Met QC Criteria
October 21, 2019
First Posted (Actual)
October 23, 2019
Study Record Updates
Last Update Posted (Actual)
December 15, 2022
Last Update Submitted That Met QC Criteria
December 12, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Dnr:2019-00998
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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