HILIT on the Physical, Functional, Cognitive and Psychological Condition of Older Adults

Older Adults Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05138497
• Other study ID #: -University of Jaén
• Status: Completed
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: April 12, 2022

Study information

• Verified date: February 2023
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 12, 2022
• Est. primary completion date: January 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Older Adults

Intervention

Other:
• HILIT
A total of 92 men and women 65 years old, distributed in an experimental group that will receive a 12-week of HILIT program (n = 46); and a 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.

Locations

Country	Name	City	State
Colombia	District of agua Blanca	Santiago de Cali

Sponsors (1)

Lead Sponsor	Collaborator
University of Jaén

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Relative risk of death due to comorbidity.	Up to twelve weeks
Primary	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
Primary	Short Physical Performance Battery (SPPB)	Short test battery, widely used in geriatrics, consists of evaluating the patient from 3 points of view: on the one hand, the patient's balance is measured, counting if he is able to maintain balance for at least 10 seconds with his feet together, in semi-tandem and tandem, counting the speed of the gait, measuring the time it takes to walk 4m, and the strength and resistance of the lower body, counting the time it takes to perform 5 squats (STS5).	Up to twelve weeks
Primary	The Berg Balance Scale (BBS)	Used to assess a person's static and dynamic balance skills.	Up to twelve weeks
Primary	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
Primary	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.	Up to twelve weeks
Primary	The physical scale of advanced life activities Reuben's day.	Evaluates the degree of integration in the community, social relationships and is sensitive to the functional assessment of individuals in the community	Up to twelve weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	FES-I (Falls Efficacy Scale-International)	Questionnaire that evaluates the fear of falling. After adding the total score, values of 16-19 indicate little fear; between 20-27, intermediate fear, and from 28-64, intense fear, representing a greater risk of falls the higher the total score.	Up to twelve weeks
Primary	Handgrip Strength	Dynamometer will be employed to assess hand grip stregth.	Up to twelve weeks
Primary	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
Primary	TUG test (Timed Up and Go test)	Is a simple test used to assess a person's mobility and physical function.	Up to twelve weeks
Secondary	SARC-F	Screening to assess the risk of sarcopenia. It generates a total score of 0-10 points, of which the range of 0-3 is recorded without sarcopenia while 4-10 suggest sarcopenia.	Up to twelve weeks
Secondary	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
Secondary	Waist circumference	Is used to assess central fat distribution and degree of abdominal obesity	Up to twelve weeks
Secondary	Hip circumference	It is measured at the level of the maximum prominence of the buttocks.	Up to twelve weeks
Secondary	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	Up to twelve weeks
Secondary	Mini Nutritional Assessment - Short Form (MNA®-SF)	It is a simple and quick method to identify elderly people who are at risk of malnutrition or undernourished.	Up to twelve weeks
Secondary	The 6-minute walk test (PC6M)	Assesses in an integrated way the response of the respiratory, cardiovascular, metabolic, skeletal muscle and neurosensory systems to the stress imposed by exercise.	Up to twelve weeks
Secondary	The 8 foot up & go test	Assesses agility and dynamic balance.	Up to twelve weeks
Secondary	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.	Up to twelve weeks
Secondary	Body Weight	Is the sum of Body Fat and Fat Free Mass.	Up to twelve weeks
Secondary	Height	It measures a person's height, measured from the sole of the foot to the top of the head.	Up to twelve weeks