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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04137211
Other study ID # Dnr:2019-00998
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 13, 2019
Est. completion date March 13, 2020

Study information

Verified date December 2022
Source The Swedish School of Sport and Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date March 13, 2020
Est. primary completion date March 13, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
Sweden The Swedish School of Sport and Health Sciences (GIH) Stockholm

Sponsors (7)

Lead Sponsor Collaborator
The Swedish School of Sport and Health Sciences ICA-gruppen, Intrum AB, Itrim, Monark Exercise, SATS, The Knowledge Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in cerebral blood flow Oxygenated and deoxygenated hemoglobin concentration changes measured with functional near-infrared spectroscopy before to after 3 hour intervention
Secondary Augmentation index as a measure of arterial stiffness before to after 3 hour intervention
Secondary Blood glucose levels during the 3 hour intervention
Secondary Cortisol before to after 3 hour intervention
Secondary Mood 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) before to after 3 hour intervention
Secondary Sleepiness measured with Karolinska Sleepiness Questionnaire; goes from 1 (extremely alert) to 9 (extremely sleepy) before to after 3 hour intervention
Secondary Cognitive performance nback cognitive test (time and accuracy) before to after 3 hour intervention
Secondary Alertness measured with a Visual Analogue Scale (VAS) before to after 3 hour intervention
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