Effect of a Multi-component Training Program With Progressive Phases on the Elderly

NCT04118478 | Completed

• 1 other identifier: EJofre
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The increase in life expectancy worldwide, added to the decrease in birth rates, has resulted in an increase in the aging population. In the case of Chile, 11.4% of its inhabitants are older adults and specifically, in the Til-Til commune, 14.65% of the total population is over 60 years of age, directly affecting the neuromuscular system and mainly cardiorespiratory. Therefore, the older person lives longer, but with a lower quality of life. Physical exercise appears as a non-pharmacological alternative to improve the quality of life, physical and cognitive functions. The "multi-component training" consists of a program that combines strength, resistance, balance and gait training, and is the one that presents the greatest improvements in the functional capacity of the elderly person. The objective of the present investigation is to relate the effects of a multi-component training schedule by phases on the quality of life, functional capacity and physiological parameters in a group of people over 60 to 80 years of age in the commune of Til-Til.

Conditions

ELDERLY PEOPLE

Keywords

fitness; program training; exercise; health; physical condition; qualilty of Life; Functional capacity; physiological status; physical activity; elderly

Outcome Measures

Primary Outcomes (14)

• Assessment of the quality of life

  The quality of life will be assessed through the SF-36 health questionnaire, which represents a generic scale that provides a profile of the state of health and is applicable to both patients and the general population.

  Change from Baseline quality life at 2, 4 and at 6 month

• Heart rate variability

  The heart rate variability (CRV) corresponds to an indicator of the modulation exerted by the autonomic nervous system, which will be analyzed in the frequency and time domains and represents an adequate analysis of the variation from beat to beat, from a point of temporal view, expressing differences in the consecutive RR intervals of the QRS complexes of an electrocardiogram. The VRC will be registered using the HRV Expert Cardiomood® smartphone application, which is capable of recording the RR intervals for analysis of the VRC indexes with high level of reliability (R = 0.97) and the H7® POLAR model heart rate monitor capable of recording these intervals as reliably (r = 0.99) as an electrocardiogram (ECG) test

  Change from Baseline Heart rate variability at 2, 4 and at 6 month

• Spirometry, forced expiratory volume in one second (FEV1)

  Spirometry is a fundamental test in functional respiratory evaluation, which is frequently used in clinical practice and in population studies, due to its good reproducibility, ease of measurement and its degree of correlation with the stage of the disease, functional condition , morbidity and mortality. Forced Espiratory Volume1, (FEV1): Amount of air that mobilizes in the first second of an expiration forced. It is a flow, not a volume (milliliters / 1 sg), so which can be expressed as ml / s or as a percentage in front of his theoretical figures. Its normal value is greater than 80% The device used to measure this pulmonary parameter will be the Manual Spirometer CMS-SP10® of small volume and easy application.

  Change from Baseline Spirometry FEV1 at 2, 4 and at 6 month

• Spirometry, peak expiratory flow (PEF)

  Spirometry is a fundamental test in functional respiratory evaluation, which is frequently used in clinical practice and in population studies, due to its good reproducibility, ease of measurement and its degree of correlation with the stage of the disease, functional condition , morbidity and mortality. Peak Espiratory Flow, (PEF): Maximum amount of air that can be exhaled by second in a forced expiration. It is the maximum peak of flow which is obtained (flow - volume curve), and is produced before having expelled 15% of the FVC. It is a marker especially useful in the diagnosis of asthma and in crises asthmatics, where predictive target value of gravity. It is measured in liters / sec, or as a percentage of the reference value. The device used to measure this pulmonary parameter will be the Manual Spirometer CMS-SP10® of small volume and easy application.

  Change from Baseline Spirometry PEF at 2, 4 and at 6 month

• Resting Heart rate

  The heart rate (HR) is determined by the balance between the sympathetic and parasympathetic systems, which responds to the body's needs at all times.

  Change from Baseline Resting Heart rate at 2, 4 and at 6 month

• Resting blood pressure

  Blood pressure (BP) shows a progressive increase with age and it is observed that systolic blood pressure shows a continuous increase, while diastolic pressure begins to decline after the age of 50 in both sexes.

  Change from resting blood pressure at 2, 4 and at 6 month

• Short Physical Performance Battery (SPPB)

  It is a battery widely used in research and covers a wide spectrum of functional levels. It has proven its validity, reproducibility and sensitivity to change in different American and European populations with good results. It is composed of three subtests: one of balance (balance with feet together, in semi-tandem and in tandem), another of leg thrust (getting up and sitting from a chair without armrests five times as quickly as possible) and a third, consisting of measuring the normal speed of walking along 4 and 6 meters. The score ranges between 0 and 12 points, and scores between 4 and 9 are suggestive of fragility.

  Change from Baseline SPPB at 2, 4 and at 6 month

• Walking speed in 4 and 6 meters

  Evaluation method that has taken great relevance recently and is even advocated as the simplest and most valid way of evaluation in the elderly. For its measurement, the time it takes for the older person to travel a certain distance is calculated (in the case of the present investigation it will be in 4 and 6 meters), and then it is passed to meters / second. It is usually evaluated at a normal pace, although it can also be done at a fast pace.

  Change from Baseline Walking speed in 4 and 6 meters at 2, 4 and at 6 month

• Time Up and Go

  It is a tool to assess the mobility and function of the lower limb, which proves to be useful, practical, fast and simple, without requiring a special team or specific training by the evaluator. Measure the time in seconds the subject takes to get up from a chair, walk 3 meters, turn, walk back to normal pace and sit down. This test has a good correlation with the measures of balance, walking speed, functionality and cognition, especially with the executive functions, memory and processing speed.

  Change from Baseline Time Up and Go at 2, 4 and at 6 month

• Dynamometry

  The use of the dynamometer allows to determine the maximum isometric force in different muscle groups. Among them, the measurement of the pressing force of the dominant hand is especially important, given that it is a simple and non-invasive marker of muscular strength of the upper extremities.

  Change from Baseline Dynamometry at 2, 4 and at 6 month

• Walking While Talking (WWT)

  This test will evaluate the speed of travel under the condition of counting backwards (from number 20 backwards) while walking at a distance of 6 meters, which has been proposed as a better instrument for measuring the speed of travel, because to which adds conditions of stress, difficulty or distraction, which presents a greater sensitivity to detect early mobility problems or preclinical disability

  Change from Baseline Walking While Talking at 2, 4 and at 6 month

• Two minutes "Step test"

  The test consists of performing the greatest number of steps marching in place for two minutes, each knee reaching an intermediate point between the patella and the anterior superior iliac spine. Although both knees must reach the correct height, only the number of times the right knee reaches the determined height is counted

  Change from Baseline Two minutes "Step test" at 2, 4 and at 6 month

• Sit and reach test

  This test will measure the flexibility of the lower body, mainly the biceps femoris and the lower back. It is an adapted version of the Wells test that measures the flexibility of both legs simultaneously, to an alternative consisting of evaluating only one lower limb sitting in a chair.

  Change from Baseline Sit and reach test at 2, 4 and at 6 month

• Back scratch test

  This test will assess the flexibility of the upper body, specifically the mobility of the shoulder joint and validly shows the expected reduction in shoulder flexibility in subjects aged 60 to 80 years.

  Change from Baseline Back scratch test at 2, 4 and at 6 month

Secondary Outcomes (5)

• Motivation for the exercise

  Change from Baseline Motivation for the exercise at 6 month

• "Physical Activity Vital Sign" (PAVS)

  Change from Baseline "Physical Activity Vital Sign" at 6 month

• "Stanford Short Activity Survey"

  Change from Baseline "Stanford Short Activity Survey" at 6 month

• Abdominal circumference

  Change from Baseline Abdominal circumference at 2, 4 and at 6 month

• Electrical impedance

  Change from Baseline Electrical impedance at 2, 4 and at 6 month

Study Arms (2)

Multi-component phased training program

EXPERIMENTAL

The intervention of the program consists of conducting a multi-component training in a neighborhood unit. The intervention will consist of the realization of a multi-component program in a training center adapted for the elderly. The duration of the program will be 27 weeks with a frequency of two weekly sessions and an intervention duration of 45 to 60 minutes

Behavioral: multi-component phased training program

CONTROL

NO INTERVENTION

Older people assigned to the GC do not do any training programming. Only attend the measurement dates.

Interventions

multi-component phased training program BEHAVIORAL

The experimental group will develop a program that consists of three progressive phases with the predominance of one physical quality over the others. The first phase will have as its main objective to develop strength, through exercises with overload and in turn, it will be subdivided into 3 blocks of 3 weeks each: Neuromuscular adaptation, muscular power, muscular resistance. The second phase will have as its main objective to develop cardiorespiratory capacity through intermittent gait training and, in turn, will be subdivided into 3 blocks of 3 weeks each: Static gait, dynamic gait and dynamic gait with changes of direction. The last phase will have as its main objective to develop balance and flexibility, by strengthening the stabilizing muscles and range of motion. In turn, this phase will be subdivided into 3 blocks of 3 weeks each: Balance / static flexibility, balance / dynamic flexibility and balance / flexibility with a double task.

Multi-component phased training program

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Universidad Catolica de murcia

Murcia, 30109, Spain

Location

Related Publications (30)

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MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Emilio Jofré-Saldía, MSc

  UCAM

  PRINCIPAL INVESTIGATOR

• Gemma García, Phd

  UCAM

  STUDY DIRECTOR

• Alvaro Villalobos, Msc

  University of Ibadan Teaching Hospital (UCH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The investigator performing the randomization will be blinded and will not participate in the recruitment process. Participants and group assignment will be blinded to investigators and technicians performing statistical analysis. Participants will be explicitly informed of their assigned group, without the possibility of modification throughout the program. The evaluation team will be made up of five researchers and technicians, two will apply the different phases of the program, one will randomly assign the participants and two others will oversee the statistical analysis. All the analysis of the results will be gathered by the same researcher. The researcher will neither know which group the participant belongs to, nor the main design of the study or the foreseen changes.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A study protocol of a randomized controlled clinical trial with blinded examiners is presented.

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 8, 2019
• Study Start: August 15, 2019
• Primary Completion: February 15, 2020
• Study Completion: July 20, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)