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Strength TrainingExecutive-19NCT03946254

Effect of Strength Training on Executive Functions in Elderly People With Mild Cognitive Impairment

A study testing Effect of strength training on executive functions in elderly people with mild cognitive impairment. in people with Strength Training and Executive Function, run by University of Seville at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Cognitive impairment or dementia is their last degree in one of the main concerns at a social level in these ages. To this day, there are different pharmacological and non-pharmacological therapies that can help prevent deterioration, as in this case, physical exercise. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Strength Training, Executive Function
What is being tested?
Effect of strength training on executive functions in elderly people with mild cognitive impairment.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSpain
Study dates
1 Sep 2019to 15 Jun 2020
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The sample is made up of people over 60 years of age, who are not active professionally, speak and understand the Spanish language.
  • In addition, they should be diagnosed with mild cognitive impairment. This will be evaluated by specialists through the minimental test (score between 24 and 28).
  • On the other hand, they should not suffer from other serious psychiatric or neurodegenerative neurological diseases.
  • In relation to mental health, it will be a reason for exclusion to have had 3 episodes of depression in the last 5 years or 10 episodes that have required some psychiatric or medical treatment.In addition,
  • The people included must be postmenopausal

Who cannot join

  • Participate in other physical exercise programs in a systematic way or in individualized and systematic programs in cognitive programs.
  • Dispose of cardiovascular diseases, heart diseases that involve an absolute contradiction of physical exercise (unstable angina, severe auroventricular block) and cerebrovascular or have suffered a heart attack in the last 6 years.
  • Have had seizures (More than 2 in the last 12 months).
  • Consumption of alcohol 20 grams / day or 2 beers or wine glasses daily.
  • Functional limitations (According to Functional activities Questionnaire)
  • Being a musician or bilingual.

Trial locations and contacts

1 site in 1 country.

manuel jesus j roldan, Sports Sci contact

650344644

jimenez.roldan.manueljesus@gmail.com

Spain1 site
  • Education Faculty

    Seville, 41013

    manuel jesus j roldan, 650344644, jimenez.roldan.manueljesus@gmail.com

    jimenez.roldan.manueljesus@gmail.com

Other trials in Spain

About this study

Cognitive impairment or dementia is their last degree in one of the main concerns at a social level in these ages. To this day, there are different pharmacological and non-pharmacological therapies that can help prevent deterioration, as in this case, physical exercise.

In the existing scientific literature, you can find a lot of information about the effect of aerobic exercise on cognition, but little is known about the effect of force exercise and its effect on general cognition and executive functions.

Therefore, in this research the investigators will investigate the effect of strength training in people over 60 with a diagnosis of mild cognitive impairment in executive functions. For this, a controlled and randomized clinical trial will be developed in the city of Seville

Read the detailed description

The training program will last 20 weeks and a frequency of 3 times / week.

During the week 0 the initial evaluation will be developed. Between weeks 1-20, the training program will be addressed. In week 21, all the changes made in all the measured variables will be evaluated.

Finally, in week 33 the variables will be measured again to see if the possible improvements given in the training program last over time.

The experimental group will perform a planned and individualized training with guided machines and training loads will be adjusted at the beginning of each week.

The control group will perform breathing and relaxation exercises to avoid a sample death.

After the intervention, there will be a follow-up phase for 3 months.

Being tested
Effect of strength training on executive functions in elderly people with mild cognitive impairment.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Effect of strength training on executive functions in elderly people with mild cognitive impairment.Other

    Strength training sessions will have a frequency of 3 times per week (Monday, Tuesday and Wednesday) for 20 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 exercises will be controlled movements and not harmful, as guided machines will be used to facilitate the execution of actions. In addition, the largest amount of muscle groups to be able to generate strength gains in all muscle groups. The control group will perform breathing exercises and low intensity stretching during the same days and with the same duration as the experimental group

Study groups in NCT03946254
Study groupRoleWhat they receive
InterventionExperimentalTHE EXPERIMENTAL GROUP WILL DEVELOP 20 WEEKS OF TRAINING TO IMPROVE THE MUSCLE CAPACITY. FOR THIS, FORCE EXERCISES WILL BE DEVELOPED IN GUIDED MACHINES.
Receives: Other: Effect of strength training on executive functions in elderly people with mild cognitive impairment.
ControlExperimentalTHE CONTROL GROUP WILL DEVELOP 20 WEEKS OF BALANCE AND BREATHING EXERCISES.
Receives: Other: Effect of strength training on executive functions in elderly people with mild cognitive impairment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline of 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 control.

    Measured: week 0

  2. 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 21

  3. Inhibitory control in the follow-up phase

    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 33

Secondary outcomes (23)
  1. Baseline of general cognition

    Global cognition is evaluated through the mini-mental test (Folstein, Folstein, \& McHugh, 1975). It is a brief and quick test to apply and is frequently used to diagnose the degree of cognitive decline. It should be noted how various variables such as the socio-educational level, and age among others, can affect the result. In addition, the mini-mental test is low cost and can be applied by any professional with a minimum of knowledge and training towards their development. The diagnostic values for mild cognitive impairment are between 24 and 28.

    Measured: Week 0

  2. Mean Change from Baseline in General cognition

    Global cognition is evaluated through the mini-mental test (Folstein, Folstein, \& McHugh, 1975). It is a brief and quick test to apply and is frequently used to diagnose the degree of cognitive decline. It should be noted how various variables such as the socio-educational level, and age among others, can affect the result. In addition, the mini-mental test is low cost and can be applied by any professional with a minimum of knowledge and training towards their development. The diagnostic values for mild cognitive impairment are between 24 and 28.

    Measured: week 21

  3. General cognition in the follow-up phase

    Global cognition is evaluated through the mini-mental test (Folstein, Folstein, \& McHugh, 1975). It is a brief and quick test to apply and is frequently used to diagnose the degree of cognitive decline. It should be noted how various variables such as the socio-educational level, and age among others, can affect the result. In addition, the mini-mental test is low cost and can be applied by any professional with a minimum of knowledge and training towards their development. The diagnostic values for mild cognitive impairment are between 24 and 28.

    Measured: week 33

  4. Baseline of physical condition

    Senior Fitness Test. This test battery allows us to evaluate the physical condition of elderly people safely. This battery can develop in ages from 60 to 94 years, encompassing various levels of physical and functional capacity (Rikli \& Jones, 1999).Due to its easy application, no specific material is required for its development, so it can be developed outside the laboratory.

    This test battery consists of 7 tests: The tests described here are quantified by the distance achieved.

    Test of flexibility of the lower extremities, Put your hands behind your back, Get up and walk and sit down again.

    In all the tests, the distance or number of repetitions made will be noted to later make comparisons with reference tables already established according to the ages.

    Measured: week 0

  5. Mean Change from Baseline in Physical condition

    Senior Fitness Test. This test battery allows us to evaluate the physical condition of elderly people safely. This battery can develop in ages from 60 to 94 years, encompassing various levels of physical and functional capacity (Rikli \& Jones, 1999).Due to its easy application, no specific material is required for its development, so it can be developed outside the laboratory.

    This test battery consists of 7 tests: The tests described here are quantified by the distance achieved.

    Test of flexibility of the lower extremities, Put your hands behind your back, Get up and walk and sit down again.

    In all the tests, the distance or number of repetitions made will be noted to later make comparisons with reference tables already established according to the ages.

    Measured: week 21

  6. Physical condition in the follow-up phase

    Senior Fitness Test. This test battery allows us to evaluate the physical condition of elderly people safely. This battery can develop in ages from 60 to 94 years, encompassing various levels of physical and functional capacity (Rikli \& Jones, 1999).Due to its easy application, no specific material is required for its development, so it can be developed outside the laboratory.

    This test battery consists of 7 tests: The tests described here are quantified by the distance achieved.

    Test of flexibility of the lower extremities, Put your hands behind your back, Get up and walk and sit down again.

    In all the tests, the distance or number of repetitions made will be noted to later make comparisons with reference tables already established according to the ages.

    Measured: week 33

  7. Baseline of physical condition variante

    Senior Fitness Test. This test battery allows us to evaluate the physical condition of elderly people safely. This battery can develop in ages from 60 to 94 years, encompassing various levels of physical and functional capacity (Rikli \& Jones, 1999).Due to its easy application, no specific material is required for its development, so it can be developed outside the laboratory.

    This test battery consists of 7 tests. The tests described here are quantified by the maximum number of repetitions performed.

    Sit and get up from a chair for 30 seconds, push-ups for 30 seconds, In all the tests, the distance or number of repetitions made will be noted to later make comparisons with reference tables already established according to the ages.

    Measured: week 0

  8. Mean Change from Baseline in Physical condition variante

    Senior Fitness Test. This test battery allows us to evaluate the physical condition of elderly people safely. This battery can develop in ages from 60 to 94 years, encompassing various levels of physical and functional capacity (Rikli \& Jones, 1999).Due to its easy application, no specific material is required for its development, so it can be developed outside the laboratory.

    This test battery consists of 7 tests. The tests described here are quantified by the maximum number of repetitions performed.

    Sit and get up from a chair for 30 seconds, push-ups for 30 seconds, In all the tests, the distance or number of repetitions made will be noted to later make comparisons with reference tables already established according to the ages.

    Measured: week 21

  9. Physical condition variante in the follow-up phase

    Senior Fitness Test. This test battery allows us to evaluate the physical condition of elderly people safely. This battery can develop in ages from 60 to 94 years, encompassing various levels of physical and functional capacity (Rikli \& Jones, 1999).Due to its easy application, no specific material is required for its development, so it can be developed outside the laboratory.

    This test battery consists of 7 tests. The tests described here are quantified by the maximum number of repetitions performed.

    Sit and get up from a chair for 30 seconds, push-ups for 30 seconds, In all the tests, the distance or number of repetitions made will be noted to later make comparisons with reference tables already established according to the ages.

    Measured: week 33

  10. Baseline of blood test

    Only 15 ml of blood will be extracted from the antecubital vein to measure the concentrations of different biochemical parameters, such as the BDFN and IGF-1. To avoid interferences in the blood analysis, it is necessary that the patient goes on an empty stomach. It is also necessary that during the previous day the participant fulfills a normal sleep monitoring cycle and that he does not eat chocolate, cocoa, tea, coffee or any other stimulant.

    Measured: week 0

  11. Mean Change from Baseline in Blood test

    Only 15 ml of blood will be extracted from the antecubital vein to measure the concentrations of different biochemical parameters, such as the BDFN and IGF-1. To avoid interferences in the blood analysis, it is necessary that the patient goes on an empty stomach. It is also necessary that during the previous day the participant fulfills a normal sleep monitoring cycle and that he does not eat chocolate, cocoa, tea, coffee or any other stimulant.

    Measured: week 21

  12. Baseline of strength

    The point of maximum power is an elaborate and accurate assessment of muscle strength and is often evaluated at a speed of 60º per second. Therefore, the Biodex 4 system will be used to assess the capacity to generate the power peak of each subjectby knee extension.

    Measured: week 0

  13. Mean Change from Baseline in Strength

    The point of maximum power is an elaborate and accurate assessment of muscle strength and is often evaluated at a speed of 60º per second. Therefore, the Biodex 4 system will be used to assess the capacity to generate the power peak of each subjectby knee extension.

    Measured: week 21

  14. Strength in the follow-up phase

    The point of maximum power is an elaborate and accurate assessment of muscle strength and is often evaluated at a speed of 60º per second. Therefore, the Biodex 4 system will be used to assess the capacity to generate the power peak of each subjectby knee extension.

    Measured: week 33

  15. 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

  16. 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 21

  17. cognitive flexibility in the follow-up phase

    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 33

  18. Baseline of cognitive flexibility variante

    "Trail Making test part B" will be used to assess cognitive flexibility. This reliable test and valid consists of a page where you must surround numbers and letters. The numbers are they extend from 1 to 13 and the letters from A to L.

    Measured: week 0

  19. Mean Change from Baseline in cognitive flexibility variante

    "Trail Making test part B" will be used to assess cognitive flexibility. This reliable test and valid consists of a page where you must surround numbers and letters. The numbers are they extend from 1 to 13 and the letters from A to L.

    Measured: week 21

  20. cognitive flexibility variante in the follow-up phase

    "Trail Making test part B" will be used to assess cognitive flexibility. This reliable test and valid consists of a page where you must surround numbers and letters. The numbers are they extend from 1 to 13 and the letters from A to L.

    Measured: week 33

  21. Baseline of working memory

    For that, wi will used the Verbal digit span forward and backward tests.This test is an excellent tool to evaluate working memory. The examiner reads a sequence of numbers and the participant must repeat it. It is composed of two parts, direct or indirect. In the first the subject must say the sequence of numbers in the order they appear. On the other hand, the indirect must name the numbers that appeared in reverse order. The length of the sequences of numbers increases progressively and two sequences with the same number are always administered. The task is suspended when the subject fails twice in the same sequence. This test gives us a measure of the attention capacity and working memory.

    Measured: week 0

  22. Mean Change from Baseline in working memory

    For that, wi will used the Verbal digit span forward and backward tests.This test is an excellent tool to evaluate working memory. The examiner reads a sequence of numbers and the participant must repeat it. It is composed of two parts, direct or indirect. In the first the subject must say the sequence of numbers in the order they appear. On the other hand, the indirect must name the numbers that appeared in reverse order. The length of the sequences of numbers increases progressively and two sequences with the same number are always administered. The task is suspended when the subject fails twice in the same sequence. This test gives us a measure of the attention capacity and working memory.

    Measured: week 21

  23. Working memory in the follow-up phase

    For that, wi will used the Verbal digit span forward and backward tests.This test is an excellent tool to evaluate working memory. The examiner reads a sequence of numbers and the participant must repeat it. It is composed of two parts, direct or indirect. In the first the subject must say the sequence of numbers in the order they appear. On the other hand, the indirect must name the numbers that appeared in reverse order. The length of the sequences of numbers increases progressively and two sequences with the same number are always administered. The task is suspended when the subject fails twice in the same sequence. This test gives us a measure of the attention capacity and working memory.

    Measured: week 33

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2019
  2. Study start1 Sep 2019 (estimated)
  3. Primary completion15 Mar 2020 (estimated)
  4. Study completion15 Jun 2020 (estimated)

Resources

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
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03946254
Sponsor's protocol ID
University of seville
Acronym
Executive-19
Status last verified
May 2019
First submitted
3 May 2019
Last updated
10 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Effect of strength training on executive functions in elderly people with mild cognitive impairment. 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 5 inclusion and 6 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 May 2019. 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?

Contact manuel jesus j roldan, Sports Sci (650344644, jimenez.roldan.manueljesus@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline of Inhibitory control (time frame: week 0). The study lists 3 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 10 May 2019.

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