Effects of exercise on brain and vascular functions in adolescents
| ISRCTN | ISRCTN11803379 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11803379 |
| Secondary identifying numbers | 202200238 |
- Submission date
- 04/08/2023
- Registration date
- 08/08/2023
- Last edited
- 08/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
There is increasing evidence of the inverse associations of sedentary behaviour and positive associations of physical activity with brain, cognitive, and vascular health in youth. A limitation of the current evidence base is a lack of understanding of how brain and vascular functions are influenced by sedentary behaviour and food intake in youth. This is a pertinent research question given that youth spend at least half of their waking hours sedentary, and 2/3 of the day may be spent in the postprandial state. This study investigates whether accumulating small volumes of exercise at moderate or high intensity across the day preserves brain and vascular functions during prolonged sitting and unhealthy meals.
Who can participate?
Healthy adolescents aged 12-14 years old without cardiovascular, metabolic, or neuromuscular conditions affecting the ability to exercise.
What does the study involve?
In this study, participants will come to the laboratory four times over a 4- to 6-week period. The first visit is a preparation session, where information about the participants' fitness level and body composition is collected. During the first visit, participants are also familiarised with the cognitive task they will be doing during the experimental visits. This is to make sure that they are familiar with it and won't be influenced by the learning process during the actual experiments. The other three visits are the actual experiment visits.
In the experimental sessions, three different conditions are tested. The first one is prolonged sitting for 7 hours, which includes activities like playing with a mobile phone. The second condition is a moderate-intensity interval exercise, where the participants will do short bouts of moderate-intensity exercise followed by a short rest. The third condition is a high-intensity interval exercise, which is more intense than the moderate one. The high-intensity exercise includes three 3-minute bouts of near-maximal intensity exercise. The number of bouts in the moderate-intensity condition matches the total work performed during high-intensity interval exercise.
During these visits, participants' cognitive functions are assessed using a computer-based task, brain function using brain scanning technology, and vascular functions using non-invasive methods.
What are the possible benefits and risks of participating?
It is possible that there are no direct benefits from participating in the study. Participants receive feedback on their cardiorespiratory fitness and physical activity levels. The risk of the study may include possible uncomfortable bodily feelings during the exercise, such as increased heart rate and exhaustion, as well as some numbness of fingers during the vascular assessments.
Where is the study run from?
Faculty of Sport and Health Sciences, University of Jyväskylä (Finland)
When the study is starting and how long is it expected to run for?
June 2021 to December 2023
Who is funding the study?
The Juho Vainio Foundation (Finland)
The Finnish Foundation for Cardiovascular Research (Finland)
Who is the main contact?
Dr Eero Haapala, eero.a.haapala@jyu.fi (Finland)
Contact information
Principal Investigator
Rautpohjankatu 8 (Viveca Building, room 247)
Faculty of Sport and Health Sciences
University of Jyväskylä
Jyväskylä
40014
Finland
 ORCID ID |
0000-0001-5096-851X |
|---|---|
| Phone | +358408054210 |
| eero.a.haapala@jyu.fi |
Scientific
Rautpohjankatu 8 (Viveca Building, room 247)
Faculty of Sport and Health Sciences
University of Jyväskylä
Jyväskylä
40014
Finland
| Phone | +358408054210 |
|---|---|
| eero.a.haapala@jyu.fi |
Public
Rautpohjankatu 8 (Viveca Building, room 247)
Faculty of Sport and Health Sciences
University of Jyväskylä
Jyväskylä
40014
Finland
| Phone | +358408054210 |
|---|---|
| eero.a.haapala@jyu.fi |
Study information
| Study design | Randomised three-arm crossover intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Laboratory |
| Study type | Prevention, Efficacy |
| Participant information sheet | 44067_PIS_Guardian.pdf |
| Scientific title | Vascular and brain health, ExeRcise, and Nutrition in Adolescents |
| Study acronym | VERNA |
| Study objectives | Interrupting prolonged sitting with a small amount of interval exercise, especially at high intensity, preserves or improves cognitive, brain, and vascular outcomes. |
| Ethics approval(s) |
Approved 17/03/2022, Ethics Committee of the Central Finland Hospital District (Keski-Suomen sairaanhoitoitopiirin tutkimuseettinen toimikunta) (Sairaala Nova, Hoitajantie 3, Jyväskylä, 40620, Finland; +358 14 269 5134; paivi.lampinen@ksshp.fi), ref: 5U/2021 |
| Health condition(s) or problem(s) studied | Prevention of prolonged sitting-induced deterioration in brain and vascular functions with exercise in apparently healthy adolescents. |
| Intervention | Each participant will make four visits to the laboratory over a 4 to 6-week period, with at least two days separating each visit. While flexible, 2 to 3 days between the sessions are aimed to allow for sufficient recovery and standardisation of the menstrual cycle in girls. To minimise the effect of the first visit, it will include the assessment of background characteristics such as cardiorespiratory fitness and body composition, and the other three visits will be experimental. During the first visit, the participants will be familiarised with the cognitive task to minimise the learning effect. Experimental conditions include: 1. Prolonged sitting (7 h, including the participant preparation) with normal sedentary behaviour such as playing with a mobile phone 2. Moderate intensity interval exercise (MIIE), consisting of the number of 1 min bouts at a 90% gas exchange threshold. The number of bouts will match the total work performed during high-intensity interval exercise. During MIIE, each bout will be separated with 75s of recovery cycling at 20W 3. High-intensity interval exercise (HIIE), consisting of a total of 9x1-minute bouts at 90% peak power with 75s of recovery cycling at 20W between each bout. The MIIE and HIIE protocols will be delivered on an electronically braked cycle ergometer. The participants perform the experimental conditions in random order. The conditions are randomised with the web-based list randomiser available at www.random.org. After the exercise bouts, the participants will consume a meal challenge consisting of ice cream, added cream, croissant, Nutella, chocolate, and cardamon bread, providing ~1.5g/kg of fat following earlier work and the typical diet composition in youth. A high-fat and sucrose diet has been found to impair brain outcomes in experimental animals and a high-fat meal has been found to impair peripheral endothelial function in adolescents and adults for hours, with an implication for possible impairment in cognitive and brain outcomes. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Executive inhibition as a measure of cognitive function is assessed by the flanker task at baseline and 1h, 2h, and 4 h after the baseline 2. Brain activity is measured by combined magnetoencephalography (MEG)–EEG with a 306-channel whole-head neuromagnetometer (Elekta Neuromag TRIUX, Elekta ltd., Stockholm, Sweden) during quiet sitting. First, resting state data as a measure of functional connectivity will be acquired for 10 minutes while the participant sits relaxed in a neuromagnetometer with eyes open. Second, the changes in the magnetic fields and electric potentials in the neural networks in response to the flanker task are assessed. |
| Secondary outcome measures | 1. Arterial stiffness measured by oscillometric tonometry (Arteriograph) and arterial tonometry (PulsePen) is measured in visit 1 and during visits 2-3 at baseline and 2h, and 4h after the baseline 2. Microvascular function, i.e., transient increase in microvascular blood flow after five-minute occlusion, is measured by the laser Doppler methodology (Moor Intruments Ltd) from the left forearm in visit 1 and during visits 2-3 at baseline and 2h, and 4h after the baseline 3. Physical activity and sedentary time are monitored for 72-h prior to the experimental visits using a thigh-worn movement and posture sensor (ActivPALmicro, PALTechonologies). Physical activity and sedentary behaviours are also measured using the PANIC Physical Activity Questionnaire, filled in during visit 1 4. Dietary factors are assessed using one-day dietary records. The participants will note down all food and drink consumed during the previous day prior to the experimental visits. The data will be analysed using the FINELI dietary analysis software (https://fineli.fi/fineli/en/ruokapaivakirja?) 5. Maximal oxygen uptake will be measured during a ramp incremental exercise test with a supramaximal verification phase on a cycle ergometer at visit 1 6. Body composition is estimated using bioelectrical impedance device (InBody 770, Biospace) in visit 1 |
| Overall study start date | 01/06/2021 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Adolescents aged 12-14 years 2. Apparently healthy (no known cardiovascular or metabolic diseases, musculoskeletal injury, serious food allergies) |
| Key exclusion criteria | 1. Metal objects in the body 2. Musculoskeletal injury preventing exercise 3. Cardiovascular or metabolic disease 4. Participating in another study at the same time |
| Date of first enrolment | 30/08/2022 |
| Date of final enrolment | 30/09/2023 |
Locations
Countries of recruitment
- Finland
Study participating centre
University of Jyväskylä
40014
Finland
Sponsor information
University/education
Seminaarinkatu 15
Jyväskylä
40014
Finland
| Phone | +358 14 260 1211 |
|---|---|
| kirjaamo@jyu.fi | |
| Website | https://www.jyu.fi/fi |
"ROR" |
https://ror.org/05n3dz165 |
Funders
Funder type
Research organisation
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Juho Vainio Foundation, Reppy Institute
- Location
- Finland
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Finnish Foundation for Cardiovascular Research
- Location
- Finland
Results and Publications
| Intention to publish date | 30/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publications created with the project are either published in peer-reviewed scientific journals favouring open-access publishing and/or parallel publication in the university repository JYX (https://jyx.jyu.fi/). The results will also be presented at international scientific conferences and meetings. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr. Eero Haapala (eero.a.haapala@jyu.fi). The research material will be carefully maintained, documented, and stored in the servers of the Information Management Center of the university. The metadata will be made publicly available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 08/08/2023 | No | Yes | ||
| Participant information sheet | 08/08/2023 | No | Yes |
Additional files
Editorial Notes
08/08/2023: Trial's existence confirmed by the Ethics Committee of the Central Finland Hospital District (Keski-Suomen sairaanhoitoitopiirin tutkimuseettinen toimikunta) (Finland).
