- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06205264
Impact of Functional Strength Training Speeds on Executive Functions in 6-12-Year-Old Children.
Effects of Functional Strength Training at Low and High Speeds on Executive Functions in Children Aged 6-12 Years.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seville, Spain, 41013
- Education Faculty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fast Group
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. |
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. |
|
Experimental: Conventional Group
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Baseline of inhibition control
Time Frame: Week 0
|
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
Time Frame: Week 9
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Baseline of cognitive flexibility
Time Frame: Week 0
|
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
|
|
Mean Change from Baseline in cognitive flexibility
Time Frame: Week 9
|
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
|
|
Baseline of working memory
Time Frame: Week 0
|
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
|
|
Mean Change from Baseline in working memory
Time Frame: Week 9
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Strength_Children_EF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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