NCT02075944

Brief Summary

The present study will investigate the effects of aerobic exercise on cognition and growth factors including brain-derived neurotrophic factor (BDNF) in young adults aged 15-21 years. The included subjects will be randomized to three different groups including one control group and two exercise groups. Subjects randomized to the exercise groups will complete 30 minutes of aerobic exercise 3 times a week for 9 weeks incorporating low (group I) or high (group II) intensity aerobic exercise. The exercise will be conducted as running or indoor cycling (supervised). At baseline and 9-weeks follow-up all subjects will complete two cognitive tests (measures of concentration and sustained attention), a maximal cycling test (direct measures of VO2max), an intelligence quotient test, anthropometric measures, fasting blood samples and blood samples immediately following the cycling test. The blood samples will be analyzed for growth factors including BDNF and metabolic factors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

4 months

First QC Date

February 27, 2014

Last Update Submit

June 25, 2014

Conditions

Keywords

Aerobic exerciseCognitive functionExecutive functionBrain-derived neurotrophic factor

Outcome Measures

Primary Outcomes (3)

  • The Flanker Task

    9 weeks

  • The AX-Continuous Performance test

    9 weeks

  • Brain-derived neurotrophic factor

    9 weeks

Secondary Outcomes (1)

  • Intelligence quotient

    9 weeks

Study Arms (3)

High intensity aerobic exercise

EXPERIMENTAL

30 minutes of high intensity aerobic exercise 3 times a weeks for 9 weeks - incorporation interval training

Behavioral: High intensity aerobic exercise

Low intensity aerobic exercise

EXPERIMENTAL

30 minutes of low intensity aerobic exercise 3 times a weeks for 9 weeks

Behavioral: Low intensity aerobic exercise

Control

NO INTERVENTION

No intervention. Participants are told not to make any changes in their everyday life

Interventions

High intensity aerobic exercise
Low intensity aerobic exercise

Eligibility Criteria

Age15 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 15-21

You may not qualify if:

  • injury preventing one from being physically active

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark

Odense, 5000, Denmark

Location

Related Publications (1)

  • Gejl AK, Bugge A, Ernst MT, Mortensen EL, Gejl KD, Andersen LB. Effects of 9 Weeks of High- or Moderate-Intensity Training on Cardiorespiratory Fitness, Inhibitory Control, and Plasma Brain-Derived Neurotrophic Factor in Danish Adolescents-A Randomized Controlled Trial. Scand J Med Sci Sports. 2024 Aug;34(8):e14703. doi: 10.1111/sms.14703.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Anne K Thorsen, Cand. Scient

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 27, 2014

First Posted

March 3, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 26, 2014

Record last verified: 2014-06

Locations