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

NCT ID: NCT05138497

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-11
• Study Completion Date: 2022-04-12

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.

Conditions

Older Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

HILIT group

An experimental group (EG) that after an initial evaluation and with their consent, will be subjected to a directed physical training program for 12 weeks with 3 weekly sessions (Monday, Wednesday and Friday), with a duration of 50 min per session. The exercises to be carried out will be divided into three different phases: warm-up during the first 10 minutes; the main part with a duration of 30 minutes (where each exercise should be performed for 20 to 30 seconds as intense or fast as possible without generating joint impact, and then take a break for 10 to 15 seconds, before repeating it); and the return to calm, based mainly on stretching exercises with a total duration of 10 minutes.

Group Type: EXPERIMENTAL

HILIT

Intervention Type: OTHER

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.

Control group

A control group (CG) that will not undergo treatment, which will be evaluated in the pre and post phase of the study. The participants assigned to this group will receive general advice on the positive effects of the regular practice of physical activity, and they will be given the guide of recommendations for the promotion of physical activity.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jaén

OTHER

Sponsor Role: lead

Responsible Party

Agustín Aibar Almazán

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

District of agua Blanca

Santiago de Cali, , Colombia

Countries

Colombia

Other Identifiers

-University of Jaén

Identifier Type: -

Identifier Source: org_study_id