Executive Function DisorderASTOEFNCT04488445
Strength Training and Executive Functions: A Randomized Controlled Trial
A study testing Strength training and Stretch and balance training in people with Executive Function Disorder and Strength Training, run by Universidad de Zaragoza at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Executive Function Disorder, Strength Training, Adolescent Behavior
- What is being tested?
- Strength training and Stretch and balance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 30 Jan 2021
- 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 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy age-schooled adolescent
Who cannot join
- Not healthy, injured age-schooled adolescent
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Zaragoza
Zaragoza, Aragon, 50009
Rubén López-Bueno, MSc, 0034661416735, rlopezbu@unizar.es
About this study
Official title: Acute Effects of Strength Training Over Executive Functions in Adolescents: A Randomized Controlled Trial
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.
Read the detailed description
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. The selected resistance exercise is based on a global muscle involvement.
- Being tested
- Strength training, Stretch and balance training
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingBehavioural
Also called Resistance training
3 sets of 3 to 5 repetitions with 4 minutes of rest between sets. 90% load of 1 maximum repetition of a resistance exercise
Stretch and balance trainingBehavioural
Also called Stretching
3 sets of 3 exercises of stretching and balance of one minute each. One minute of resting time between sets.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Stretch and balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to successfully complete the executive function test
Executive function
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Sep 2020
- Primary completion6 Nov 2020
- Study completion30 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Executive Function DisorderStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubén López-Bueno, Universidad de Zaragoza
- Investigators
- Joaquín Calatayud, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488445
- Sponsor's protocol ID
- UZaragoza13091978
- Acronym
- ASTOEF
- Status last verified
- Nov 2020
- First submitted
- 18 Jul 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Strength Training Over Executive Functions in Adolescents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04488445
- Acronym / sponsor ID
- ASTOEF / UZaragoza13091978
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 30 Jan 2021 (estimated)
- First posted
- 28 Jul 2020 (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.
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
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. The selected resistance exercise is based on a global muscle involvement.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength Training | Experimental | Behavioral: Strength trainingThe 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. |
| Stretching | Placebo comparator | Behavioral: Stretch and balance trainingThe control group performs 3 exercises of stretching and balance during one minute each and three sets. One minute of resting time between sets. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy age-schooled adolescent
Key exclusion criteria (1 listed)
- Not healthy, injured age-schooled adolescent
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 trainingAlso: Resistance training3 sets of 3 to 5 repetitions with 4 minutes of rest between sets. 90% load of 1 maximum repetition of a resistance exercise | Behavioural | Strength Training |
| Stretch and balance trainingAlso: Stretching3 sets of 3 exercises of stretching and balance of one minute each. One minute of resting time between sets. | Behavioural | Stretching |
Primary outcome
Time to successfully complete the executive function test
Time frame: up to 24 weeks
Executive function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Joaquín Calatayud, PhD principal investigator
University of Valencia
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 and Stretch and balance training in people with Executive Function Disorder and Strength Training, run by Universidad de Zaragoza 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 1 inclusion and 1 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 10 Nov 2020. 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. Some participants in this study may receive a placebo. 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?
Contact Rubén López-Bueno, MSc (0034662416735, rlopezbu@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to successfully complete the executive function test (time frame: up to 24 weeks). 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 10 Nov 2020.