Clinical trial NCT04638322: 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
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Aging
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 52
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: MoCA (Montreal Cognitive Assessment)
timeFrame: Up to twelve weeks.
measure: TMT (Trail Making Test)
timeFrame: Up to twelve weeks.
measure: Isaacs test
timeFrame: Up to twelve weeks.
measure: SFT (Senior Fitness Test)
timeFrame: Up to twelve weeks.
measure: The Lawton & Brody scale
timeFrame: Up to twelve weeks
measure: The Short Form-36 Health Survey (SF-36)
timeFrame: Up to twelve weeks
measure: The Yesavage Geriatric Depression Scale
timeFrame: Up to twelve weeks
measure: Mini-Mental State Examination (MMSE)
timeFrame: Up to twelve weeks
measure: PSQI (Pittsburgh Sleep Quality Index)
timeFrame: Up to twelve weeks
measure: Tinetti scale
timeFrame: Up to twelve weeks
measure: Frailty phenotype
timeFrame: Up to twelve weeks
measure: The 8 foot up & go test
timeFrame: Up to twelve weeks
measure: KATZ INDEX
timeFrame: Up to twelve weeks
measure: Chair sit and reach test
timeFrame: Up to twelve weeks
measure: Back scratch test
timeFrame: Up to twelve weeks
Secondary outcomes:
measure: D2 test
timeFrame: Up to twelve weeks.
measure: DSST (The Digit Symbol Substitution Test)
timeFrame: Up to twelve weeks.
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: Up to twelve weeks.
measure: Handgrip Strength
timeFrame: Up to twelve weeks.
measure: BMI (Body Mass Index)
timeFrame: Up to twelve weeks.
measure: Waist circumference
timeFrame: Up to twelve weeks.
measure: Waist-to-hip ratio
timeFrame: Up to twelve weeks.
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Fundación Casa de los Tiempos
state: Valle Del Cauca
Study officials:
References: