Effects of Functional Training by High Intensity Intervals in Older Adults With Mild Cognitive Impairment.

NCT04638322 | Completed

• 1 other identifier: University of Jaén (2020)
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Aging

Outcome Measures

Primary Outcomes (15)

• MoCA (Montreal Cognitive Assessment)

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

  Up to twelve weeks.

• TMT (Trail Making Test)

  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.

  Up to twelve weeks.

• Isaacs test

  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.

  Up to twelve weeks.

• SFT (Senior Fitness Test)

  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.

  Up to twelve weeks.

• The Lawton & Brody scale

  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.

  Up to twelve weeks

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

  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.

  Up to twelve weeks

• The Yesavage Geriatric Depression Scale

  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.

  Up to twelve weeks

• Mini-Mental State Examination (MMSE)

  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.

  Up to twelve weeks

• PSQI (Pittsburgh Sleep Quality Index)

  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.

  Up to twelve weeks

• Tinetti scale

  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.

  Up to twelve weeks

• Frailty phenotype

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

  Up to twelve weeks

• The 8 foot up & go test

  Assesses agility and dynamic balance.

  Up to twelve weeks

• KATZ INDEX

  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.

  Up to twelve weeks

• Chair sit and reach test

  To test low back and hamstring flexibility.

  Up to twelve weeks

• Back scratch test

  To measure general shoulder range of motion.

  Up to twelve weeks

Secondary Outcomes (7)

• D2 test

  Up to twelve weeks.

• DSST (The Digit Symbol Substitution Test)

  Up to twelve weeks.

• Mindful Attention Awareness Scale (MAAS)

  Up to twelve weeks.

• Handgrip Strength

  Up to twelve weeks.

• BMI (Body Mass Index)

  Up to twelve weeks.

Study Arms (2)

HIFT Group

EXPERIMENTAL

This group receives physical training based on exercises of high intensity interval functional training.

Other: HIFT Group

No intervention group

NO INTERVENTION

This group does not receive any treatment.

Interventions

HIFT Group OTHER

An experimental group (EG) that after an initial evaluation will be subjected to a physical training program based on the HIFT method, for 12 weeks with 2 weekly sessions (Tuesday and Thursday), with a duration of 45 min per session. Once the intervention is finished, you will undergo a final evaluation to see if there is a difference or not with the results obtained at the beginning.

HIFT Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Fundación Casa de los Tiempos

Cali, Valle del Cauca Department, 760031, Colombia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 20, 2020
• Study Start: February 1, 2021
• Primary Completion: April 23, 2021
• Study Completion: May 1, 2021
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

CO (1)