NCT06205264

Brief Summary

The cognitive development in children involves fundamental changes in their thinking and understanding of the environment, enhancing skills such as attention, memory, and problem-solving. This development is linked to intelligence and mental processes, positively affecting academic performance. The prefrontal cortex, the seat of executive functions, undergoes maturation, crucial for planning and behavior regulation. Factors such as rest, language learning, and physical activity influence these functions. The study highlights the interconnection between executive functions and cognitive development in children, emphasizing the importance of early stimulation. Physical activity, especially strength training, emerges as a determinant in improving cognition and executive functions, with intensity playing a crucial role. Therefore, the aim is to investigate the effect of strength training, focusing on increased intentional execution speed compared to a constant low-speed approach.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

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

January 3, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

17 days

First QC Date

January 3, 2024

Last Update Submit

January 3, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Baseline of inhibition control

    To measure the inhibitory control, the "Stroop test" will be used. It is a short test and consists of 3 parts. In the first part they must read the greatest number of words in a sheet with a total of 100 words that appear in 5 columns. For 45 seconds they should read the largest number of words. At the end of the time the number will be written down of words read. Next, they should identify colors from a list of symbols without meaning, but colored in different colors. The subject will have to identify and name the greatest number of colors. Finally, the subject is given a list of words with the name of colors, but written with a different color from the one the word refers to.This test aims to assess the inhibitory control.

    Week 0

  • Mean Change from Baseline in Inhibitory control

    To measure the inhibitory control, the "Stroop test" will be used. It is a short test and consists of 3 parts. In the first part they must read the greatest number of words in a sheet with a total of 100 words that appear in 5 columns. For 45 seconds they should read the largest number of words. At the end of the time the number will be written down of words read. Next, they should identify colors from a list of symbols without meaning, but colored in different colors. The subject will have to identify and name the greatest number of colors. Finally, the subject is given a list of words with the name of colors, but written with a different color from the one the word refers to.This test aims to assess the inhibitory controlof words read.

    Week 9

Secondary Outcomes (4)

  • Baseline of cognitive flexibility

    Week 0

  • Mean Change from Baseline in cognitive flexibility

    Week 9

  • Baseline of working memory

    Week 0

  • Mean Change from Baseline in working memory

    Week 9

Study Arms (2)

Fast Group

EXPERIMENTAL

Effect of strength training on executive functions in children. Strength training sessions will have a frequency of 3 times per week (Monday, Tuesday and Wednesday) for 8 weeks. In addition, each subject is subject to an individualized training program according to the workload in order to progressively increase the intensity of work. The workload will be modified progressively by influencing both the total volume of repetitions and the intensity of the exercises. The multi joint exercises will be controlled movements and not harmful, but at maximum speed during the concentric phase of the exercise.

Other: Strength training at high and low speeds.

Conventional Group

EXPERIMENTAL

Effect of strength training on executive functions in children. Strength training sessions will have a frequency of 3 times per week (Monday, Tuesday and Wednesday) for 8 weeks. In addition, each subject is subject to an individualized training program according to the workload in order to progressively increase the intensity of work. The workload will be modified progressively by influencing both the total volume of repetitions and the intensity of the exercises. This group will perform each phase of the planned exercises at a constant speed.

Other: Strength training at high and low speeds.

Interventions

The training program will last for 8 weeks with a frequency of 3 sessions per week. Session duration will be 40-60 minutes, depending on the week within the developed schedule. To form the groups, participants will be randomly divided into two groups. On one hand, the explosive group will perform exercises in less time with faster movements, while the conventional group will execute the training with slower movements. The entire session will be designed and supervised by three exercise specialists. Each child must have a written informed consent completed by their parent/guardian. Three days of strength training will be conducted following WHO recommendations, emphasizing multi-joint exercises.

Conventional GroupFast Group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Be between 6 and 12 years old.
  • No practical contraindications for physical exercise.
  • No psychological therapy.
  • No mental illness.

You may not qualify if:

  • History of Serious Musculoskeletal Injuries
  • Medical Conditions Limiting Participation in Physical Activity
  • Absence of Informed Consent from Parents or Guardians

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Education Faculty

Seville, 41013, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: After the random assignment of the groups, the coaches will be oblivious to the investigation, so there is no bias.Furthermore, the principal investigator will not know where the data of each group comes from.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2024

First Posted

January 12, 2024

Study Start

January 15, 2024

Primary Completion

February 1, 2024

Study Completion

May 1, 2024

Last Updated

January 12, 2024

Record last verified: 2024-01

Locations