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

NCT05138497 | Completed

• 1 other identifier: -University of Jaén
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Older Adults

Outcome Measures

Primary Outcomes (15)

• 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

• 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

• 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

• The Berg Balance Scale (BBS)

  Used to assess a person's static and dynamic balance skills.

  Up to twelve weeks

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Handgrip Strength

  Dynamometer will be employed to assess hand grip stregth.

  Up to twelve weeks

• 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

• 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 Outcomes (11)

• SARC-F

  Up to twelve weeks

• Frailty phenotype

  Up to twelve weeks

• Waist circumference

  Up to twelve weeks

• Hip circumference

  Up to twelve weeks

• Waist-to-hip ratio

  Up to twelve weeks

Study Arms (2)

HILIT group

EXPERIMENTAL

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.

Other: HILIT

Control group

NO INTERVENTION

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.

Interventions

HILIT 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.

HILIT group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

District of agua Blanca

Santiago de Cali, 760020, Colombia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: For the assignment to the groups, a random sampling will be carried out from the Epidat program. This classification will be hidden, therefore, those responsible for admitting patients to the intervention phase will not know which group each has been assigned to. Said assignment will be previously carried out by a researcher who will not intervene in the subsequent phases of evaluation, data recording intervention and database development. The assignment will be communicated by sealed and totally opaque envelopes. The analysis of the results will be carried out by a researcher outside the group assignment and the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: December 1, 2021
• Study Start: January 11, 2022
• Primary Completion: January 18, 2022
• Study Completion: April 12, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

CO (1)