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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06205264
Other study ID # Strength_Children_EF
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 15, 2024
Est. completion date May 1, 2024

Study information

Verified date January 2024
Source University of Seville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The training program will last 8 weeks and a frequency of 3 times / week. During the week 0 the initial evaluation will be developed. Between weeks 1-8, the training program will be addressed. In week 9, all the changes made in all the measured variables will be evaluated. Both groups will follow the same training program involving multi-joint exercises, but the Fast group will perform the concentric phase at maximum intentional speed. The Conventional Group will execute all exercises at controlled speeds.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date May 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: - Be between 6 and 12 years old. - No practical contraindications for physical exercise. - No psychological therapy. - No mental illness. Exclusion Criteria: - History of Serious Musculoskeletal Injuries - Medical Conditions Limiting Participation in Physical Activity - Absence of Informed Consent from Parents or Guardians

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Strength training at high and low speeds.
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.

Locations

Country Name City State
Spain Education Faculty Seville

Sponsors (1)

Lead Sponsor Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Baseline of cognitive flexibility To evaluate the cognitive flexibility, will be used the WISCONSIN TEST. This test consists of two sets of 64 cards. The letters present various combinations according to 4 geometric shapes, 4 colors and 4 quantities. Week 0
Secondary Mean Change from Baseline in cognitive flexibility To evaluate the cognitive flexibility, will be used the WISCONSIN TEST. This test consists of two sets of 64 cards. The letters present various combinations according to 4 geometric shapes, 4 colors and 4 quantities. Week 9
Secondary Baseline of working memory To evaluate working memory, the DIGIT SPAN TEST will be employed. This test involves presenting a series of numbers to the participant, who is then required to recall and repeat them in the same order (forward digit span) or in reverse order (backward digit span). The test assesses the individual's ability to temporarily store and manipulate information in their working memory. The results of the DIGIT SPAN TEST will contribute valuable insights into the impact of the strength training program on participants' cognitive functions, particularly their working memory capacity. Week 0
Secondary Mean Change from Baseline in working memory To evaluate working memory, the DIGIT SPAN TEST will be employed. This test involves presenting a series of numbers to the participant, who is then required to recall and repeat them in the same order (forward digit span) or in reverse order (backward digit span). The test assesses the individual's ability to temporarily store and manipulate information in their working memory. Week 9
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