Condition category
Mental and Behavioural Disorders
Date applied
10/11/2015
Date assigned
16/11/2015
Last edited
11/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The brain of a child and that of an adult are organised very differently. In adolescence the brain undergoes extensive remodelling, maturing and building connections. It is during this time that the cerebral cortex (the folded, outer part of the brain) undergoes extensive changes, marking the development of complex thinking processes, increasing a persons’ capacity for learning. There are many known benefits of taking part in regular physical activity for the body, but there is a good deal of evidence that it is also valuable for healthy cerebral development. Despite this, teenagers are becoming increasingly inactive, many becoming overweight or obese. Many studies have shown that cognitive function (mental abilities such as thinking, reasoning, memory and attention) is improved after taking part in exercise in children, boosting academic performance. The aim of this study is to find out whether taking part in high-intensity exercise will help to improve cognitive function and learning in adolescents.

Who can participate?
Healthy adolescents aged between 15 and 17 who attend a participating high school or vocational school.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in three 20 minute exercise sessions every week during school hours. In these sessions, participants complete a warm up (low intensity), and then high intensity exercise such as running or circuit training, followed by a short low intensity cool down. Those in the second group continue with their usual exercise regime and have no extra training sessions. At the start of the study and then again after three months, participants in both groups have a scan to test their brain activity, as well as completing a number of tests to find out if there has been any change to their cognitive function.

What are the possible benefits and risks of participating?
Participants will benefit from taking part in the study are they will be able to receive detailed information about their health and fitness levels, as well as feedback about any changes they could make to improve. There is a small risk of injury during the exercise training, although measures will be taken to prevent this.

Where is the study run from?
University of Jyväskylä (Finland)

When is the study starting and how long is it expected to run for?
January 2015 to December 2018

Who is funding the study?
Jenny and Antti Wihuri Foundation (Finland)

Who is the main contact?
Dr Eero Haapala

Trial website

Contact information

Type

Scientific

Primary contact

Dr Eero Haapala

ORCID ID

http://orcid.org/0000-0001-5096-851X

Contact details

Department of Biology of Physical Activity
PO-Box 35 (VIV)
University of Jyväskylä
Jyväskylä
40014
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

High-intensity exercise training intervention study to improve cognitive functions and learnining in adolescents

Acronym

NEEDS

Study hypothesis

High-intensity and low-volume exercise intervention will improve cognitive function and learning in the study group compared to the control group during the three month intervention period.

Ethics approval

Ethics committee of University of Jyväskylä, 25/08/2015

Study design

Single-centre single-blind cluster-randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Cognition, learning, brain function

Intervention

Participants are randomly allocated to the intervention group or the control group.

Intervention group: Participants will take part in high-intensity and low volume exercise training during school days. The aim of the exercise intervention is to provide three short (approximately 20 minute) exercise sessions weekly and to improve cardio-respiratory fitness and motor performance, totaling in all 24 sessions over the 2-month intervention period. As a training mode high intensity running and circuit training will be adopted. The protocol includes 3 minute warm-up at light to moderate intensity and eight to twelve repeated bouts of 1 minute at 90% to 100% of the capacity of the participants interspersed by 75–90 second recovery at light intensity, followed by 3 minute recovery period at light to moderate intensity.

Control Group: Participants will continue their usual physical activity behavior without supervised exercise by the study.

After the intervention period, the participants will be followed-up until the end of vocational and high school for approximately for two years (from baseline) but no intervention is provided during follow-up.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Attention, working memory, associative learning, processing speed and executive function is measured using the computerized CogState battery at the baseline and at the 3 months
2. Reading and arithmetic skills are measured using pseudo word reading and KTLT tests, respectively, at the baseline and at the 3 months
3. Brain functions by magnetoencephalography (MEG) at baseline and 3 months

Secondary outcome measures

1. Cardiorespiratory fitness is measured using maximal cycle ergometer test with respiratory gas analyses at baseline and 3 months
2. Physical activity is measured using PA-3D accelerometer, the Youth Physical Activity Questionnaire and the Youth Sedentary Behaviour questionnaire at baseline and 3-months
3. Sleep length and quality is measured using the Epworth sleepiness scale and Basic Nordic Sleep Questionnaire at baseline and 3 months
4. Arterial stiffness is measured using an Arteriograph at baseline and 3 months
5. Adiposity is measured using dual-energy x-ray absorbtiomerty at baseline and using bio-impedance device at baseline and 3 months
6. Motivation is measured using a questionnaire developed by Professor Niemivirta in the 2002 study "Motivation and performance in context: The influence of goal orientations and instructional setting on situational appraisal and task performance" at baseline and 3 months
7. Self-efficacy is measured using a questionnaire developed by Professor Niemivirta in the 2002 study "Motivation and performance in context: The influence of goal orientations and instructional setting on situational appraisal and task performance" at baseline and 3 months
8. Depression is measured using the 21 item Beck Depression Scale at baseline and 3 months

Overall trial start date

11/01/2015

Overall trial end date

30/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 15-17 years of age
2. Attending high school and vocational schools

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

We aim to reqruite approximately 200 participants in 6 clusters based on schools and approximately 30 participants in each clusterfor detailed neurocognitive laboratory tests.

Participant exclusion criteria

1. Heart disease
2. Untreated or poorly controlled type 1 diabetes
3. Musculoskeletal disease or trauma
4. Severe depression or anxiety

Recruitment start date

01/12/2015

Recruitment end date

30/01/2017

Locations

Countries of recruitment

Finland

Trial participating centre

University of Jyväskylä
Department of Biology of Physical Activity
Jyväskylä
FI-40014
Finland

Sponsor information

Organisation

University of Jyväskylä

Sponsor details

Department of Biology of Physical Activity
PL 35
Jyväskylä
40014
Finland

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Jenny ja Antti Wihurin Rahasto

Alternative name(s)

Jenny and Antti Wihuri Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Finland

Funder name

Päivikki and Sakari Sohlberg Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication to a peer reviewed journal in the form of a preliminary results paper and a main results paper.

Intention to publish date

30/06/2018

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/05/2016: Päivikki and Sakari Sohlberg Foundation was added to the funders list.