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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Strength Training Executive Function | Other: Effect of strength training on executive functions in elderly people with mild cognitive impairment. | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Masking 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. |
| Primary Purpose: | Prevention |
| Official Title: | Effect of Strength Training on Executive Functions in Elderly People With Mild Cognitive Impairment |
| Estimated Study Start Date : | September 1, 2019 |
| Estimated Primary Completion Date : | March 15, 2020 |
| Estimated Study Completion Date : | June 15, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Intervention
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.
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
|
|
Experimental: Control
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.
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
|
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.
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.
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.
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.
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.
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.
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.
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.
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.
| Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: manuel jesus j roldan, Sports Sci | 650344644 | jimenez.roldan.manueljesus@gmail.com |
| Spain | |
| Education Faculty | |
| Seville, Spain, 41013 | |
| Contact: manuel jesus j roldan 650344644 jimenez.roldan.manueljesus@gmail.com | |
| Contact jimenez.roldan.manueljesus@gmail.com | |
| Principal Investigator: manuel jesus j Jiménez Roldán | |
| Principal Investigator: | manuel jesus j roldan, Sports Sci | University of Seville |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 3, 2019 | ||||
| First Posted Date ICMJE | May 10, 2019 | ||||
| Last Update Posted Date | May 10, 2019 | ||||
| Estimated Study Start Date ICMJE | September 1, 2019 | ||||
| Estimated Primary Completion Date | March 15, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Strength Training on Executive Functions in Elderly People With Mild Cognitive Impairment | ||||
| Official Title ICMJE | Effect of Strength Training on Executive Functions in Elderly People With Mild Cognitive Impairment | ||||
| Brief 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. 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 |
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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Investigator, Outcomes Assessor) Masking 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. Primary Purpose: Prevention
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| Condition ICMJE |
|
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| Intervention ICMJE | Other: Effect of strength training on executive functions in elderly people with mild cognitive impairment.
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
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Estimated Enrollment ICMJE |
40 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | June 15, 2020 | ||||
| Estimated Primary Completion Date | March 15, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 60 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Spain | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03946254 | ||||
| Other Study ID Numbers ICMJE | University of seville | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Manuel Jesús, University of Seville | ||||
| Study Sponsor ICMJE | University of Seville | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | University of Seville | ||||
| Verification Date | May 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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