Strength Training and Executive Functions: A Randomized C... | NCT04488445

Studies
Strength Training and Executive Functions: A Randomized Controlled Trial

NCT04488445

Sponsor

Universidad de Zaragoza

Status

Unknown status

Last Update Posted

Nov 10, 2020Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Executive Function Disorder
Strength Training
Adolescent Behavior
Academic Achievement

Interventions

Strength training
Stretch and balance training

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Nov 6, 2020Actual

Completion Date

Jan 30, 2021Estimated

First Submitted Date

Jul 18, 2020

First Submission Date that Met QC Criteria

Jul 22, 2020

First Posted Date

Jul 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2020

Last Update Posted Date

Nov 10, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rubén López-Bueno, Principal Investigator, Universidad de ZaragozaPrincipal Investigator

Lead Sponsor

Universidad de ZaragozaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Strength training	Behavioral	3 sets of 3 to 5 repetitions with 4 minutes of rest between sets. 90% load of 1 maximum repetition of a resistance exercise	Strength Training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to successfully complete the executive function test	Executive function	up to 24 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy age-schooled adolescent

Exclusion Criteria:

Not healthy, injured age-schooled adolescent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rubén López-Bueno, MSc	Contact	0034662416735		rlopezbu@unizar.es

Overall Officials

Name	Affiliation	Role
Joaquín Calatayud, PhD	University of Valencia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Zaragoza	Recruiting	Zaragoza	Aragon	50009	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000294	Adolescent Behavior

Ancestor Terms

ID	Term
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055070	Resistance Training

Ancestor Terms

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided