NCT03946254

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

7 months

First QC Date

May 3, 2019

Last Update Submit

May 9, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (23)

  • Baseline of general cognition

    Week 0

  • Mean Change from Baseline in General cognition

    week 21

  • General cognition in the follow-up phase

    week 33

  • Baseline of physical condition

    week 0

  • Mean Change from Baseline in Physical condition

    week 21

  • +18 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Control

EXPERIMENTAL

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.

Interventions

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

ControlIntervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • The people included must be postmenopausal

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Education Faculty

Seville, 41013, Spain

Location

Study Officials

  • manuel jesus j roldan, Sports Sci

    University of Seville

    PRINCIPAL INVESTIGATOR

Central Study Contacts

manuel jesus j roldan, Sports Sci

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Science of physical activity and sport

Study Record Dates

First Submitted

May 3, 2019

First Posted

May 10, 2019

Study Start

September 1, 2019

Primary Completion

March 15, 2020

Study Completion

June 15, 2020

Last Updated

May 10, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations