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Register:	ISRCTN
Last refreshed on:	9 January 2023
Main ID:	ISRCTN12991197
Date of registration:	16/11/2015
Prospective Registration:	Yes
Primary sponsor:	University of Jyväskylä
Public title:	Neural effects of exercise, diet and sleep
Scientific title:	High-intensity exercise training intervention study to improve cognitive functions and learnining in adolescents
Date of first enrolment:	01/12/2015
Target sample size:	40
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN12991197
Study type:	Interventional
Study design:	Current study design: Single-centre single-blind parallel controlled cross-over study Previous study design: Single-centre single-blind cluster-randomized controlled trial (Other)
Phase:	Not Applicable

Countries of recruitment
Finland

Contacts

Name:	Eero Haapala
Address:	Sport and Exercise Medicine Faculty of Sport and Health Sciences PO-Box 35 (VIV) University of Jyväskylä 40014 Jyväskylä Finland
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
Current inclusion criteria as of 17/03/2017:
1. Aged 15-19 years of age
2. Attending high school and vocational schools

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

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cognition, learning, brain function
Mental and Behavioural Disorders
Cognition, learning, brain function

Intervention(s)

Current Interventions as of 17/03/2017:
Participants are allocated to the intervention group or the control group.

Intervention group: Participants 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, totaling in all 12 sessions over the 1-month intervention period. As a training mode high intensity running will be adopted. The protocol includes 3 minute warm-up at light to moderate intensity and eight to twelve repeated bouts of 0.5 to 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.

In the sub-study, the participants participate in three brain scans. First scan is performed two weeks before second visit to the laboratory. During the second visit, the participants perform a brain scan before and after the acute high intensity interval exercise. The exercise is performed using mechanically braked cycle ergometer. The exercise protocol include eight 30-second maximal intensity exercise bouts interspersed by 90-second active recovery.

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

There is no follow-up planned.

Previous Interventions:
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

Primary Outcome(s)

Current primary outcome measures as of 17/03/2017:
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. Brain functions by magnetoencephalography (MEG) in a subsample of participants taking part in sub study investigating the effects of acute high intensity interval training on cognition and brain functioning.

Previous 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(s)

Current secondary outcome measures as of 17/03/2017:
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. 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
6. 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
7. Depression is measured using the 21 item Beck Depression Scale at baseline and 3 months

Previous 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

Secondary ID(s)

N/A

Source(s) of Monetary Support

Jenny ja Antti Wihurin Rahasto, Päivikki and Sakari Sohlberg Foundation

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

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

Results

Results available:	Yes
Date Posted:
Date Completed:	30/12/2018
URL:

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