Strength TrainingNCT06205264
Impact of Functional Strength Training Speeds on Executive Functions in 6-12-Year-Old Children.
A study testing Strength training at high and low speeds. in people with Strength Training and Executive Function, run by University of Seville at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Strength Training, Executive Function, Child
- What is being tested?
- Strength training at high and low speeds.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2024to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Be between 6 and 12 years old.
- No practical contraindications for physical exercise.
- No psychological therapy.
- No mental illness.
Who cannot join
- History of Serious Musculoskeletal Injuries
- Medical Conditions Limiting Participation in Physical Activity
- Absence of Informed Consent from Parents or Guardians
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Functional Strength Training at Low and High Speeds on Executive Functions in Children Aged 6-12 Years.
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.
Read the 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.
- Conditions
- Strength Training, Executive Function, Child
- Being tested
- Strength training at high and low speeds.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training at high and low speeds.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Strength training at high and low speeds. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 9
Secondary outcomes (4)
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.
Measured: Week 0
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.
Measured: Week 9
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.
Measured: Week 0
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.
Measured: Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start15 Jan 2024 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strength TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jimenez-Roldan Manuel Jesus, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205264
- Sponsor's protocol ID
- Strength_Children_EF
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional Strength Training at Low and High Speeds on Executive Functions in Children Aged 6-12 Years.
- ClinicalTrials.gov ID
- NCT06205264
- Acronym / sponsor ID
- Strength_Children_EF
- Conditions
- Strength Training, Executive Function, Child
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fast Group | Experimental | Other: Strength training at high and low speeds.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. |
| Conventional Group | Experimental | Other: Strength training at high and low speeds.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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Be between 6 and 12 years old.
- No practical contraindications for physical exercise.
- No psychological therapy.
- No mental illness.
Key exclusion criteria (3 listed)
- History of Serious Musculoskeletal Injuries
- Medical Conditions Limiting Participation in Physical Activity
- Absence of Informed Consent from Parents or Guardians
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Conventional Group, Fast Group |
Primary outcome
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.
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.
4 secondary outcomes
Baseline of cognitive flexibility
Time frame: Week 0
Mean Change from Baseline in cognitive flexibility
Time frame: Week 9
Baseline of working memory
Time frame: Week 0
Mean Change from Baseline in working memory
Time frame: Week 9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
Related trials for Strength Training
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Not yet recruiting
Effect of High Intensity Interval Training on Strength, Endurance and Flexibility
High Intensity Interval Training
Not yet recruiting
Exercise in Alzheimer's Disease: Functional Biomarkers
Alzheimer's Dementia (AD), Alzheimer Disease (AD)
Active, not recruiting
Flexibility, Resistance, Aerobic, Movement Execution Training in Adults With Hereditary Spastic Paraplegia
Hereditary Spastic Paraplegia
Recruiting
IMST for Dementia Risk Reduction
Systolic Blood Pressure, Blood Pressure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training at high and low speeds. in people with Strength Training and Executive Function, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline of inhibition control (time frame: Week 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.