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

Primary Purpose

Quality of Life, Aging

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
HIFT Group
Sponsored by
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • More than 60 years
  • 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.

Sites / Locations

  • Fundación Casa de los Tiempos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HIFT Group

No intervention group

Arm Description

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

This group does not receive any treatment.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Frailty phenotype
Five original characteristics are evaluated: involuntary weight loss, self-reported exhaustion, slow gait speed, weakness, and low physical activity.
The 8 foot up & go test
Assesses agility and dynamic balance.
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.
Chair sit and reach test
To test low back and hamstring flexibility.
Back scratch test
To measure general shoulder range of motion.

Secondary Outcome Measures

D2 test
Time-limited test to measure concentration. The test measures the processing speed, the following of instructions and the goodness of the execution in a task of discrimination of similar visual stimuli and that, therefore, allow the estimation of attention and concentration.
DSST (The Digit Symbol Substitution Test)
Cognitive test to assess processing speed presented on a single sheet of paper that requires a subject to match symbols with numbers according to a key located at the top of the page. The subject copies the symbol into spaces below a row of numbers. The number of correct symbols within the allowed time, usually 90-120 seconds, constitutes the score.
Mindful Attention Awareness Scale (MAAS)
It evaluates, in a global way, the dispositional capacity of an individual to be attentive and aware of the experience of the present moment in everyday life. The scale is a 15-item univariate self-report with a view of the mindfulness construct centered on the attention / consciousness variable.
Handgrip Strength
Dynamometer will be employed to assess hand grip stregth.
BMI (Body Mass Index)
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat
Waist circumference
Is used to assess central fat distribution and degree of abdominal obesity
Waist-to-hip ratio
Is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement

Full Information

First Posted
October 27, 2020
Last Updated
February 14, 2023
Sponsor
University of Jaén
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1. Study Identification

Unique Protocol Identification Number
NCT04638322
Brief Title
Effects of Functional Training by High Intensity Intervals in Older Adults With Mild Cognitive Impairment.
Official Title
Effects of a High Intensity Interval Functional Training Program on the Cognitive and Functional Capabilities of Older Adults With Mild Cognitive Impairment.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 23, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Aging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Care ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIFT Group
Arm Type
Experimental
Arm Description
This group receives physical training based on exercises of high intensity interval functional training.
Arm Title
No intervention group
Arm Type
No Intervention
Arm Description
This group does not receive any treatment.
Intervention Type
Other
Intervention Name(s)
HIFT Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
MoCA (Montreal Cognitive Assessment)
Description
Instrument that examines the skills of attention, concentration, executive functions, memory, language, visuoconstructive abilities, calculation and orientation and the maximum score is 30.
Time Frame
Up to twelve weeks.
Title
TMT (Trail Making Test)
Description
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.
Time Frame
Up to twelve weeks.
Title
Isaacs test
Description
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.
Time Frame
Up to twelve weeks.
Title
SFT (Senior Fitness Test)
Description
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.
Time Frame
Up to twelve weeks.
Title
The Lawton & Brody scale
Description
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.
Time Frame
Up to twelve weeks
Title
The Short Form-36 Health Survey (SF-36)
Description
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.
Time Frame
Up to twelve weeks
Title
The Yesavage Geriatric Depression Scale
Description
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.
Time Frame
Up to twelve weeks
Title
Mini-Mental State Examination (MMSE)
Description
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.
Time Frame
Up to twelve weeks
Title
PSQI (Pittsburgh Sleep Quality Index)
Description
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.
Time Frame
Up to twelve weeks
Title
Tinetti scale
Description
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.
Time Frame
Up to twelve weeks
Title
Frailty phenotype
Description
Five original characteristics are evaluated: involuntary weight loss, self-reported exhaustion, slow gait speed, weakness, and low physical activity.
Time Frame
Up to twelve weeks
Title
The 8 foot up & go test
Description
Assesses agility and dynamic balance.
Time Frame
Up to twelve weeks
Title
KATZ INDEX
Description
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.
Time Frame
Up to twelve weeks
Title
Chair sit and reach test
Description
To test low back and hamstring flexibility.
Time Frame
Up to twelve weeks
Title
Back scratch test
Description
To measure general shoulder range of motion.
Time Frame
Up to twelve weeks
Secondary Outcome Measure Information:
Title
D2 test
Description
Time-limited test to measure concentration. The test measures the processing speed, the following of instructions and the goodness of the execution in a task of discrimination of similar visual stimuli and that, therefore, allow the estimation of attention and concentration.
Time Frame
Up to twelve weeks.
Title
DSST (The Digit Symbol Substitution Test)
Description
Cognitive test to assess processing speed presented on a single sheet of paper that requires a subject to match symbols with numbers according to a key located at the top of the page. The subject copies the symbol into spaces below a row of numbers. The number of correct symbols within the allowed time, usually 90-120 seconds, constitutes the score.
Time Frame
Up to twelve weeks.
Title
Mindful Attention Awareness Scale (MAAS)
Description
It evaluates, in a global way, the dispositional capacity of an individual to be attentive and aware of the experience of the present moment in everyday life. The scale is a 15-item univariate self-report with a view of the mindfulness construct centered on the attention / consciousness variable.
Time Frame
Up to twelve weeks.
Title
Handgrip Strength
Description
Dynamometer will be employed to assess hand grip stregth.
Time Frame
Up to twelve weeks.
Title
BMI (Body Mass Index)
Description
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat
Time Frame
Up to twelve weeks.
Title
Waist circumference
Description
Is used to assess central fat distribution and degree of abdominal obesity
Time Frame
Up to twelve weeks.
Title
Waist-to-hip ratio
Description
Is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement
Time Frame
Up to twelve weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fundación Casa de los Tiempos
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760031
Country
Colombia

12. IPD Sharing Statement

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

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