Assessing Cognitive and Health Improvements in the Elderly Via Exercise (ACHIEVE) - Study.

NCT06052644 | Completed

• 1 other identifier: University of Jaén-
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

In Colombia, a demographic transition is occurring that is reflected in an inverted population pyramid, with an increase in the proportion of older adults due to a better quality of life, as well as a decrease in the young population due to the low birth rate. These changes pose challenges for the healthcare system due to aging and its negative consequences for the body. The rate of aging has increased fourfold since 1950, which means a significant increase in the population of older adults compared to those under 15 years of age. Although exercise has been proven to have positive effects on the physical and cognitive health of older adults, there are still gaps in the literature concerning cognitive impairment in older adults, and the optimal dose to achieve maximum therapeutic potential has not been determined. Therefore, the purpose of this research is to establish the optimal dose-response relationship to high-intensity exercise for improving cognition in older adults with mild cognitive impairment. A Randomized Controlled Clinical Trial with four groups will be conducted. One of the groups will serve as the control and will not receive treatment, focusing on occupational activities. The other three groups will be experimental, and the frequency and duration of exercise will be modified based on the World Health Organization (WHO) guidelines and a previous systematic research with meta-analysis. In the first experimental group (EG1), the WHO recommendations will be applied, consisting of 150 minutes of high-intensity exercise three times a week in sessions of 50 minutes each. In EG2, participants will perform high-intensity exercise twice a week, with a duration of 30 minutes per session. In EG3, high-intensity exercise will be performed four times per week in sessions of 50 minutes each. All experimental groups will receive high-intensity physical exercise interventions that combine aerobic and strength exercises adapted to the population. The sessions will be divided into three phases: warm-up, core phase, and cool-down. Different sociodemographic, cognitive, and physical condition variables will be evaluated. All dependent variables will be measured before and after the intervention, and statistical analysis will determine which exercise prescription yielded the best results in terms of cognitive improvement. This research aims to provide valuable information about the optimal dose of high-intensity exercise to improve cognition in older adults with mild cognitive impairment in Colombia."

Conditions

Aging; Exercise

Outcome Measures

Primary Outcomes (2)

• General cognition

  General cognition will be assessed with the Montreal Cognitive Assessment (MoCA), which evaluates executive and visuospatial function, memory, attention, language, abstraction, recall memory, and orientation. The total possible score is 30 points; a score of 26 or above is considered normal.

  Up to twelve weeks

• Senior Fitness Battery (SFB)

  Physical condition and functional capacity variables will be assessed using the Senior Fitness Battery (SFB). The SFB includes tests for upper and lower limb muscle strength (arm curl and chair stand tests, respectively), aerobic capacity (6-minute walk test), lower limb flexibility (sit-and-reach test), upper limb flexibility (back scratch test), and dynamic agility and balance (8-foot up-and-go test).

  Up to twelve weeks

Secondary Outcomes (1)

• Trail Making Test part A and part B

  Up to twelve weeks

Other Outcomes (8)

• Verbal fluency

  Up to twelve weeks

• D2 test

  Up to twelve weeks

• Digit Symbol Substitution Test (DSST)

  Up to twelve weeks

Study Arms (4)

Control Group (CG)

NO INTERVENTION

The control group will not carry out any type of intervention. You will receive physical activity recommendations from the Pan American Health Organization, developed by sports science professionals.

EXPERIMENTAL GROUP 1 (EG1)

EXPERIMENTAL

This group will engage in high-intensity physical exercise for 150 minutes per week, three days a week, with each session lasting 50 minutes. The session structure will include a 5-minute warm-up, 40 minutes of the core phase, and 5 minutes of cool down.

Other: Exercise Dose-Response

EXPERIMENTAL GROUP 2 (EG2)

EXPERIMENTAL

Participants in this group will perform high-intensity exercise twice a week, with each session lasting 30 minutes. The session structure will include a 5-minute warm-up, 20 minutes of the core phase, and 5 minutes of cool down.

Other: Exercise Dose-Response

EXPERIMENTAL GROUP 3 (EG3)

EXPERIMENTAL

This group will engage in high-intensity exercise four times a week, with each session lasting 50 minutes. The session structure will include a 5-minute warm-up, 40 minutes of the core phase, and 5 minutes of cool down.

Other: Exercise Dose-Response

Interventions

Exercise Dose-Response OTHER

The intervention will last for 12 weeks. Depending on the group, participants will engage in the intervention either four times a week or only two times, with the duration ranging from 30 to 60 minutes per session. Each session will consist of three phases: an initial warm-up phase, a central phase, and a cool-down phase. The warm-up phase will focus on joint mobility, beginning with flexion-extension, rotation, and lateral neck flexion while maintaining eye contact with a fixed point. This will be followed by trunk mobility exercises, including rotations. The central phase will consist of aerobic and strength training performed at an intensity of 80-85% of the maximum heart rate. Each exercise will be performed intensely for 20 to 30 seconds, followed by a rest period of 10 to 15 seconds before repeating the exercise.

EXPERIMENTAL GROUP 1 (EG1); EXPERIMENTAL GROUP 2 (EG2); EXPERIMENTAL GROUP 3 (EG3)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Men and women aged over 65 who voluntarily agree to participate in the study and are not engaged in any other physical exercise program
• Possess adequate physical autonomy to participate in the required physical activities for the study
• Exhibit mild cognitive impairment (with a score of \<25 on the Mini-Mental State Examination)
• Have the capacity to comprehend the instructions, programs, and protocols of this trial.

You may not qualify if:

• People with contraindications for physical or exercise tests will be excluded. This includes individuals diagnosed with pathologies such as cancer, pulmonary hypertension, renal failure, heart failure, orphan diseases, psychiatric conditions, neurological or cognitive impairments, or Human Immunodeficiency Virus (HIV/AIDS) infection or disease.
• Individuals who do not consent to participate in the study or have declined to endorse the use of their data for research purposes in the informed consent at the time of program entry will also be excluded.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Retos Salud Mental

Cali, Valle del Cauca Department, 760001, Colombia

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To allocate participants to their respective groups, we will employ random sampling facilitated by the Epidat program. This grouping process will remain concealed, ensuring that the individuals responsible for enrolling patients into the intervention phase remain unaware of the group assignments. An independent researcher, uninvolved in the subsequent stages of assessment, intervention, data collection, or database creation, will perform this allocation in advance. The group assignments will be communicated via sealed and completely opaque envelopes. The subsequent analysis of the results will be conducted by a separate researcher who has no involvement in either the group assignment process or the intervention itself.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: January 11, 2024
• Primary Completion: May 20, 2024
• Study Completion: July 13, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

CO (1)