Clinical trial NCT05138497: HILIT on the Physical, Functional, Cognitive and Psychological Condition of Older Adults
Official title: Effects of a Program Based on High Intensity Interval Training and Low Impact on Physical, Functional, Cognitive and Psychological Condition in Colombians Older Than 65 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 92
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To analyze the effects of a program based on high intensity interval training and low impact on the state of health and the physical, functional, cognitive and psychological condition in Colombian people over 65 years of age.

Detailed description: This research corresponds to an experimental study, a double-blind randomized controlled clinical trial, where a total of 92 men and women 65 years old will be evaluated, distributed in two groups: the experimental group will receive a Beat Fit-type HILIT program (n = 46) 12 weeks; and the control group (n = 46) that will only receive general recommendations on the benefits of physical exercise. The variables will be measured for both groups with the same validated tools and the same researcher to avoid information biases and differential incorrect classification. The evaluations will be carried out at the beginning of the intervention and immediately after the end of this period, and the results will be recorded in a data record that will later be unified in an Excel database registering a code for each participant to maintain condition of privacy, but at the same time allow the required comparability.

For the independent variables, the sociodemographic characteristics, clinical history and the socio-family assessment scale will be addressed; The result variables are divided by areas: those focused on health status will measure the relative risk of death due to Comorbidity from the Charlson Index, Health-related Quality of Life \[HRQoL\] with the SF36 questionnaire, the Questionnaire To determine sarcopenia, it will be the SARC-F (Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls) and the Fried fragility phenotype will be applied. For the physical condition variables, the ECFA battery will be used; for the execution of sequential locomotive tasks it will be measured with the "8-foot up-and-go test"; gait and balance from the Tinetti Scale, Gait Speed with the 6-minute Test; and postural stability and balance from the Berg Scale. For the functional variables, the Katz Index (activities of daily living), the Lawton \& Brody Index of the Vice-Rector's Office for Undergraduate, Postgraduate and Permanent Training (instrumental activities of daily life) and the Siu and Reuben physical scale ( Advanced activities of daily living). For the Cognitive Variable, the Minimental Status Examination (MMSE) and for the psychological variables, Yesavage will be applied for depression, the Pittsburgh Index for sleep quality and fear of falling with the international scale FES-I (Falls Efficacy Scale-International). All variables will have pre and post intervention measurements. As a result, a dance-based HILIT training program (Beat Fit) is expected to improve the health, physical, functional, cognitive and psychological condition of Colombian adults over 65 years of age, thus contributing to the comprehensive approach of this population. Once the intervention is completed, the final evaluation will be carried out and, from the comparative process, define if there are significant differences with respect to the results obtained initially.

Eligibility criteria: Inclusion Criteria:

* Men and women over 65 years of age, who voluntarily agree to participate in the study.
* Be able to understand the instructions and exercise protocols for this project.

Exclusion Criteria:

* Contraindications to the performance of physical tests or exercise.
* People with a diagnosis of pathologies such as cancer, pulmonary hypertension and kidney failure, a population with a diagnosis of heart failure or orphan diseases, a population with a psychiatric diagnosis and / or management, or with neurological or cognitive alterations.
* People with a diagnosis of Human Immunodeficiency Virus (HIV / AIDS) infection or disease.
* Do not agree to participate in the study or those who at the time of entry to the program have denied the endorsement of the use of their data for research in informed consent.

Primary outcomes:
measure: Charlson index. Absence of comorbidity is considered when the score is 0-1 points, low comorbidity 2 points and high cormobility in scores equal to or greater than 3 points.
timeFrame: Up to twelve weeks
measure: The Short Form-36 Health Survey (SF-36)
timeFrame: Up to twelve weeks
measure: Short Physical Performance Battery (SPPB)
timeFrame: Up to twelve weeks
measure: The Berg Balance Scale (BBS)
timeFrame: Up to twelve weeks
measure: KATZ INDEX
timeFrame: Up to twelve weeks
measure: The Lawton & Brody scale
timeFrame: Up to twelve weeks
measure: The physical scale of advanced life activities Reuben's day.
timeFrame: Up to twelve weeks
measure: Mini-Mental State Examination (MMSE)
timeFrame: Up to twelve weeks
measure: MoCA (Montreal Cognitive Assessment)
timeFrame: Up to twelve weeks
measure: The Yesavage Geriatric Depression Scale
timeFrame: Up to twelve weeks
measure: PSQI (Pittsburgh Sleep Quality Index)
timeFrame: Up to twelve weeks
measure: FES-I (Falls Efficacy Scale-International)
timeFrame: Up to twelve weeks
measure: Handgrip Strength
timeFrame: Up to twelve weeks
measure: Tinetti scale
timeFrame: Up to twelve weeks
measure: TUG test (Timed Up and Go test)
timeFrame: Up to twelve weeks
Secondary outcomes:
measure: SARC-F
timeFrame: Up to twelve weeks
measure: Frailty phenotype
timeFrame: Up to twelve weeks
measure: Waist circumference
timeFrame: Up to twelve weeks
measure: Hip circumference
timeFrame: Up to twelve weeks
measure: Waist-to-hip ratio
timeFrame: Up to twelve weeks
measure: Mini Nutritional Assessment - Short Form (MNA®-SF)
timeFrame: Up to twelve weeks
measure: The 6-minute walk test (PC6M)
timeFrame: Up to twelve weeks
measure: The 8 foot up & go test
timeFrame: Up to twelve weeks
measure: BMI (Body Mass Index)
timeFrame: Up to twelve weeks
measure: Body Weight
timeFrame: Up to twelve weeks
measure: Height
timeFrame: Up to twelve weeks
Other outcomes:
Locations:
city: Santiago de Cali
country: Colombia
facility: District of agua Blanca
Study officials:
References: