NCT04488445

Brief Summary

A group of 50 age-schooled adolescents was randomized into one intervention and another control group of 25 subjects each. After estimating one maximum repetition for all the participants in a previous session, the intervention group performed a resistance training based on a resistance exercise of 3 sets of 3 to 5 repetitions (90% of an estimated 1 RM) whereas the control group performed both stretching and balance exercises. Measures of executive functions ( i.e. a cognitive function associated with academic performance) were taken for all the participants before and after the training. Both independent and paired t-test will serve to check differences between and within groups respectively.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 18, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

July 18, 2020

Last Update Submit

November 8, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to successfully complete the executive function test

    Executive function

    up to 24 weeks

Study Arms (2)

Strength Training

EXPERIMENTAL

The intervention group performs a resistance training based on a resistance exercise of 3 sets of 3 to 5 repetitions (90% of an estimated 1 RM) and 3 minutes of resting time between sets.

Behavioral: Strength training

Stretching

PLACEBO COMPARATOR

The control group performs 3 exercises of stretching and balance during one minute each and three sets. One minute of resting time between sets.

Behavioral: Stretch and balance training

Interventions

3 sets of 3 to 5 repetitions with 4 minutes of rest between sets. 90% load of 1 maximum repetition of a resistance exercise

Also known as: Resistance training
Strength Training

3 sets of 3 exercises of stretching and balance of one minute each. One minute of resting time between sets.

Also known as: Stretching
Stretching

Eligibility Criteria

Age15 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy age-schooled adolescent

You may not qualify if:

  • Not healthy, injured age-schooled adolescent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zaragoza

Zaragoza, Aragon, 50009, Spain

RECRUITING

MeSH Terms

Conditions

Adolescent Behavior

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Joaquín Calatayud, PhD

    University of Valencia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rubén López-Bueno, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 18, 2020

First Posted

July 28, 2020

Study Start

September 1, 2020

Primary Completion

November 6, 2020

Study Completion

January 30, 2021

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations