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Clinical Trials/NCT04638322
NCT04638322CompletedNot Applicable

Effects of a High Intensity Interval Functional Training Program on the Cognitive and Functional Capabilities of Older Adults With Mild Cognitive Impairment.

University of Jaén2 sites in 1 country52 target enrollmentStarted: February 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
52
Locations
2
Primary Endpoint
MoCA (Montreal Cognitive Assessment)

Study Overview

Brief Summary

To analyze the effects of a high intensity interval functional training program (HIFT), in the cognitive and functional capacities of Colombian older adults with mild cognitive impairment.

Detailed Description

This is a randomized clinical trial of single-blind with 2 arms (Control group and experimental group), in which a pre-treatment-postest design has been used.

The study will define two groups:

A control group (CG) that will not be submitted to treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity and will be given a guide to recommendations for promoting physical activity.

An experimental group (GE) that after an initial evaluation will undergo a physical training program based on high intensity interval functional training exercises.

Once the intervention is finished, it will be submitted to a final evaluation to see if there is a difference or not with the results obtained at the beginning.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Care Provider, Investigator, Outcomes Assessor)

Masking Description

The assignment to the groups will be of simple random type and hidden. Those responsible for admitting patients to the intervention phase will not know what group has been assigned each. This assignment will be made in advance by a researcher who will not intervene in the later stages of evaluation, intervention, data recording and elaboration of database. The assignment will be communicated through sealed and totally opaque envelopes.

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • More than 60 years
  • Adults with mild cognitive impairment
  • Not participating in any physical exercise program
  • Sufficient physical autonomy to participate in the physical activities required by the study
  • Have no signs of dementia (<26 on MoCA)
  • Be able to understand instructions, programs and protocols.

Exclusion Criteria

  • Contraindications for conducting physical tests
  • Diseases that limit cognitive performance and physical activity.

Outcomes

Primary Outcomes

MoCA (Montreal Cognitive Assessment)

Time Frame: Up to twelve weeks.

Instrument that examines the skills of attention, concentration, executive functions, memory, language, visuoconstructive abilities, calculation and orientation and the maximum score is 30.

PSQI (Pittsburgh Sleep Quality Index)

Time Frame: Up to twelve weeks

A simple and valid assessment of both sleep quality and disturbance that might affect. They consist of 10 questions divided into four subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use and daytime dysfunctions, adding up to a total score. The higher value represents a worse result. Higher scores indicate poorer sleep.

Tinetti scale

Time Frame: Up to twelve weeks

It is used to determine early the risk of falling in an elderly person during the year following its application. The result of both sections will be added, so that a score of less than 19 points will imply a high risk of falls, a score of 19 to 24 will reflect medium risk of falls and a score of 25 to 28 will indicate low risk of falls.

SFT (Senior Fitness Test)

Time Frame: Up to twelve weeks.

Instrument used to assess functional abilities. It consists of the following tests: muscle strength (upper and lower limbs), aerobic endurance, flexibility (upper and lower limbs) and agility, 6-minute walk test, Sit-to-foot test using a chair (measures flexibility of the lower body, Try to clasp hands behind your back, Try to get up, walk 8 feet and sit back.

The Yesavage Geriatric Depression Scale

Time Frame: Up to twelve weeks

Questionnaire used to screen for depression in older people. Scores from 00 to 05 indicate Normal screening, 06 to 10 Moderate Depression screening, and 11 to 15 Severe Depression screening.

The 8 foot up & go test

Time Frame: Up to twelve weeks

Assesses agility and dynamic balance.

TMT (Trail Making Test)

Time Frame: Up to twelve weeks.

It is used to assess executive function. It measures timed motor and visual tasks, and is divided into two tests: Part A (TMTA), which assesses speed and psychomotor attention and requires connecting consecutively numbered circles; and Part B (TMTB), which tests executive function and requires connecting alternating circles of numbers and letters. Longer completion times indicate poor performance.

The Lawton & Brody scale

Time Frame: Up to twelve weeks

Evaluates independence and functionality in instrumental activities of daily life) such as shopping, cooking, cleaning, washing, finances, medication, transportation and use of the telephone; and considers instrumental disability the inability to perform one or more activities. Each area is scored according to the description that best corresponds to the subject. Therefore, each area scores a maximum of 1 point and a minimum of 0 points. The maximum dependence would be marked by obtaining 0 points, while a sum of 8 points would express total independence. In a conventional way, the following classification can be assumed: Grades A-B or 0 - 1 points = absence of disability or mild disability. Grades C-D or 2 - 3 points = moderate disability. Grades E-G or 4 - 6 points = severe disability.

The Short Form-36 Health Survey (SF-36)

Time Frame: Up to twelve weeks

Used extensively for assessing health-related quality of life. The results are values between 0 and 100. Optimal health is represented by scores of 100 and very poor health would equal 0.

Chair sit and reach test

Time Frame: Up to twelve weeks

To test low back and hamstring flexibility.

Isaacs test

Time Frame: Up to twelve weeks.

Instrument used to assess verbal fluency. Participants have 60 seconds to generate as many words as possible within a given semantic category (animals, colors, fruits, and cities). The maximum score is 40 points (with a maximum of 10 per category). The higher the score, the better the level of verbal fluency.Instrument used to assess verbal fluency. Participants have 60 seconds to generate as many words as possible within a given semantic category (animals, colors, fruits, and cities). The maximum score is 40 points (with a maximum of 10 per category). The higher the score, the better the level of verbal fluency.

KATZ INDEX

Time Frame: Up to twelve weeks

Is a widely used tool to assess the level of independency in older adults. It is scored considering the items grouped to obtain degrees A, B, C, etc., of independence. It is observed that 0 points are equal to grade A, 1 point to grade B, 2 points to grade C, 3 points to grade D, and so on. In a conventional way, the following classification can be assumed: Grades A-B or 0 - 1 points = absence of disability or mild disability. Grades C-D or 2 - 3 points = moderate disability. Grades E-G or 4 - 6 points = severe disability.

Back scratch test

Time Frame: Up to twelve weeks

To measure general shoulder range of motion.

Mini-Mental State Examination (MMSE)

Time Frame: Up to twelve weeks

The most widely used cognitive screening test to assess suspected symptoms consistent with cognitive impairment or dementia. Written test with a maximum score of 30. The cut-off point established for the MMSE defines "normal" cognitive function is generally set at 24, lower scores indicate more serious cognitive problems.

Frailty phenotype

Time Frame: Up to twelve weeks

Five original characteristics are evaluated: involuntary weight loss, self-reported exhaustion, slow gait speed, weakness, and low physical activity.

Secondary Outcomes

  • BMI (Body Mass Index)(Up to twelve weeks.)
  • Handgrip Strength(Up to twelve weeks.)
  • Waist circumference(Up to twelve weeks.)
  • D2 test(Up to twelve weeks.)
  • Mindful Attention Awareness Scale (MAAS)(Up to twelve weeks.)
  • DSST (The Digit Symbol Substitution Test)(Up to twelve weeks.)
  • Waist-to-hip ratio(Up to twelve weeks.)

Investigators

Sponsor
University of Jaén
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Agustín Aibar Almazán

Principal investigator

University of Jaén

Study Sites (2)

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