Healthy AdultsNCT04137211
Acute Effects of Sitting and Physical Activity on Brain Health
A study testing Prolonged sitting with social break, Prolonged sitting with walk break and Prolonged sitting with simple resistance activities in people with Healthy Adults, run by The Swedish School of Sport and Health Sciences at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Prolonged sitting with social break, Prolonged sitting with walk break and Prolonged sitting with simple resistance activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSweden
- Study dates
- 13 May 2019to 13 Mar 2020
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has a BMI under 35kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
The Swedish School of Sport and Health Sciences (GIH)
Stockholm, 114 86
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Adults
- Being tested
- Prolonged sitting with social break, Prolonged sitting with walk break, Prolonged sitting with simple resistance activities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged sitting with social breakBehavioural
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 breakBehavioural
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 activitiesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged sitting with social break | Experimental | Not described Receives: Behavioral: Prolonged sitting with social break |
| Prolonged sitting with walk break | Experimental | Not described Receives: Behavioral: Prolonged sitting with walk break |
| Prolonged sitting with simple resistance activities | Experimental | Not described Receives: Behavioral: Prolonged sitting with simple resistance activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cerebral blood flow
Oxygenated and deoxygenated hemoglobin concentration changes measured with functional near-infrared spectroscopy
Measured: before to after 3 hour intervention
Secondary outcomes (7)
Augmentation index
as a measure of arterial stiffness
Measured: before to after 3 hour intervention
Blood glucose levels
Measured: during the 3 hour intervention
Cortisol
Measured: before to after 3 hour intervention
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)
Measured: before to after 3 hour intervention
Sleepiness
measured with Karolinska Sleepiness Questionnaire; goes from 1 (extremely alert) to 9 (extremely sleepy)
Measured: before to after 3 hour intervention
Cognitive performance
nback cognitive test (time and accuracy)
Measured: before to after 3 hour intervention
Alertness
measured with a Visual Analogue Scale (VAS)
Measured: before to after 3 hour intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start13 May 2019
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Swedish School of Sport and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Knowledge Foundation, ICA-gruppen, Intrum AB, SATS - Sport Aerobic Trenings Senter, Monark Exercise, Itrim
- Responsible party
- Sponsor
- Investigators
- Maria Ekblom, PhD, Principal investigator, The Swedish School of Sport and Health Sciences (GIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137211
- Sponsor's protocol ID
- Dnr:2019-00998
- Status last verified
- Dec 2022
- First submitted
- 15 Oct 2019
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heiland EG, Tarassova O, Fernstrom M, English C, Ekblom O, Ekblom MM. Frequent, Short Physical Activity Breaks Reduce Prefrontal Cortex Activation but Preserve Working Memory in Middle-Aged Adults: ABBaH Study. Front Hum Neurosci. 2021 Sep 16;15:719509. doi: 10.3389/fnhum.2021.719509. eCollection 2021.
PubMed 34602995
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Sitting and Physical Activity on Cerebrovascular Circulation Among Adults
- ClinicalTrials.gov ID
- NCT04137211
- Acronym / sponsor ID
- Dnr:2019-00998
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- The Swedish School of Sport and Health SciencesUniversity, hospital or other
- Collaborators
- The Knowledge Foundation, ICA-gruppen, Intrum AB, SATS - Sport Aerobic Trenings Senter, Monark Exercise, Itrim
- Study start
- 13 May 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 23 Oct 2019 (actual)
- 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 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prolonged sitting with social break | Experimental | Behavioral: Prolonged sitting with social break |
| Prolonged sitting with walk break | Experimental | Behavioral: Prolonged sitting with walk break |
| Prolonged sitting with simple resistance activities | Experimental | Behavioral: Prolonged sitting with simple resistance activities |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Has a BMI under 35kg/m2
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Prolonged sitting with social breakParticipants 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. | Behavioural | Prolonged sitting with social break |
| Prolonged sitting with walk breakParticipants 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. | Behavioural | Prolonged sitting with walk break |
| Prolonged sitting with simple resistance activitiesParticipants 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. | Behavioural | Prolonged sitting with simple resistance activities |
Primary outcome
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
7 secondary outcomes
Augmentation index
Time frame: before to after 3 hour intervention
Blood glucose levels
Time frame: during the 3 hour intervention
Cortisol
Time frame: before to after 3 hour intervention
Mood
Time frame: before to after 3 hour intervention
Sleepiness
Time frame: before to after 3 hour intervention
Cognitive performance
Time frame: before to after 3 hour intervention
Alertness
Time frame: before to after 3 hour intervention
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 15 Dec 2022.
- Derived from this study: PubMed 34602995Heiland EG, Tarassova O, Fernstrom M, English C, Ekblom O, Ekblom MM. Frequent, Short Physical Activity Breaks Reduce Prefrontal Cortex Activation but Preserve Working Memory in Middle-Aged Adults: ABBaH Study. Front Hum Neurosci. 2021 Sep 16;15:719509. doi: 10.3389/fnhum.2021.719509. eCollection 2021.
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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.
Maria Ekblom, PhD principal investigator
The Swedish School of Sport and Health Sciences (GIH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged sitting with social break, Prolonged sitting with walk break and Prolonged sitting with simple resistance activities in people with Healthy Adults, run by The Swedish School of Sport and Health Sciences at 1 site in Sweden.
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 1 inclusion and 3 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 15 Dec 2022. 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 Sweden. 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?
Changes in cerebral blood flow (time frame: before to after 3 hour intervention). 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 NCT04137211, which also lists 1 linked publication.
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 15 Dec 2022.