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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Strength Training, Executive Function

Intervention / Treatment
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* Other: Effect of strength training on executive functions in elderly people with mild cognitive impairment.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>THE EXPERIMENTAL GROUP WILL DEVELOP 20 WEEKS OF TRAINING TO IMPROVE THE MUSCLE CAPACITY. FOR THIS, FORCE EXERCISES WILL BE DEVELOPED IN GUIDED MACHINES. | Other: Effect of strength training on executive functions in elderly people with mild cognitive impairment.<br>* 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<br>|
| Experimental: Control<br>THE CONTROL GROUP WILL DEVELOP 20 WEEKS OF BALANCE AND BREATHING EXERCISES. | Other: Effect of strength training on executive functions in elderly people with mild cognitive impairment.<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | week 21 | 
| 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. | week 33 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 0 | 
| 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. | week 21 | 
| 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. | week 33 | 
| 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. | week 0 | 
| 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. | week 21 | 
| 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. | week 33 | 
| 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. | week 0 | 
| 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. | week 21 | 
| 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. | week 33 | 
| 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. | week 0 | 
| 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. | week 21 | 
| 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. | week 0 | 
| 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. | week 21 | 
| 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. | week 33 | 
| 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 | 
| 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 21 | 
| 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. | week 33 | 
| 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. | week 0 | 
| 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. | week 21 | 
| 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. | week 33 | 
| 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. | week 0 | 
| 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. | week 21 | 
| 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. | week 33 |