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

Study Overview
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Brief Summary
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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.

Detailed Description
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The intervention consists of carrying out a 27-week multi-component training program divided into 3 phases of 9 weeks each, where the physical qualities will be progressively worked together twice a week. However, in each phase the development of one physical quality will predominate over the others. Each session will be supervised by two experienced physical educators in the area, they will also be trained two weeks prior to the intervention and supervised weekly by the principal investigator. 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 (block 1), muscular power (block 2), muscular resistance (block 3). Each session will last approximately 45 minutes at an intensity of 70-75% of one maximum repetition (1RM) and with an effort character from light to maximum. The session will consist of 10 minutes of mobility and muscle activation as a warm-up, 25 minutes of strength exercises and 10 minutes of stretching as a return to calm. 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 (block 1), dynamic gait (block 2) and dynamic gait with changes of direction (block 3). Each session will last approximately 50 minutes with an effort perception of 6-8. The session will consist of 10 minutes of mobility and muscular activation as a warm-up, 10 minutes of muscular power exercises, 20 minutes of cardiorespiratory endurance and 10 minutes of stretching as a return to calm. 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 (block 1), balance / dynamic flexibility (block 2) and balance / flexibility with a double task (block 3). Each session will last approximately 60 minutes with a perception of effort of 6-8. The session will consist of 10 minutes of mobility and muscle activation as a warm-up, 10 minutes of power exercises, 10 minutes of cardiorespiratory endurance, 20 minutes of balance exercises and 10 minutes of stretching as a return to calm).

Official Title
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Effects of Multicomponent Exercise Program With Progressive Phases on Functional Capacity, Fitness, Quality of Life, Dual-Task and Physiological Variables in Older Adults: Randomized Controlled Trial Protocol

Conditions
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ELDERLY PEOPLE

Intervention / Treatment
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* Behavioral: multi-component phased training program


Participation Criteria
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Eligibility Criteria
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The inclusion criteria are: a) being between 60 to 80 years old, b) being able to move with or without personal / technical assistance, c) able to communicate, d) autonomy to give consent or, otherwise, be assisted by a relative or legal representative. Exclusion criteria are any factors that exclude the performance of the physical training program or testing procedures as determined by the treating physician. These factors include, but are not limited to, the following: a) terminal disease, b) acute myocardial infarction in the past 3 months, c) unstable cardiovascular disease or other medical condition, d) fracture of the upper or lower extremity in the last 3 months, e) severe dementia, f) unwillingness to complete study requirements or to be randomized to the control or intervention group.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A study protocol of a randomized controlled clinical trial with blinded examiners is presented.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-component phased training program<br>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<br>* 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.<br>|
| No Intervention: CONTROL<br>Older people assigned to the GC do not do any training programming. Only attend the measurement dates. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation for the exercise | The motivation for the physical exercise will be evaluated through the Questionnaire of the Regulation of the Conduct in the Exercise (BREQ-3), which is headed by the sentence I do physical exercise ... in 23 items: Four for intrinsic regulation , four for integrated regulation (because it agrees with my way of life, because I consider that physical exercise is part of me, because I see physical exercise as a fundamental part of who I am, because I consider that the physical exercise is in accordance with my values ), three for identified regulation, four for introjected regulation, four for external regulation and four for demotivation. | Change from Baseline Motivation for the exercise at 6 month | 
| Physical Activity Vital Sign (PAVS) | The level of physical activity will be recorded through two questionnaire: Vital Sign of Physical Activity (SVAF). The SVAF was developed as a simple questionnaire for use in a clinical setting with the objective of assessing moderate to vigorous physical activity (AFMV) of the last week and of a typical (usual) week. | Change from Baseline Physical Activity Vital Sign at 6 month | 
| Stanford Short Activity Survey | Stanford Short Activity Survey was developed to classify the levels of physical activity at work and during leisure time. The study used five brief descriptions of physical activity profiles, which are named inactive at high levels of commitment to exercise. Respondents select one profile for work and another for free time. | Change from Baseline Stanford Short Activity Survey at 6 month | 
| Abdominal circumference | The measurement will be performed with a SECA S201® measuring tape with an accuracy of 0.1 cm. The tape will be located in the midpoint between the internal rib edge of the last rib intercepted with the anterior axillary line and the iliac crest and it will be verified that the person is not inspired or forced expiration, registering the waist circumference obtained in centimeters . | Change from Baseline Abdominal circumference at 2, 4 and at 6 month | 
| Electrical impedance | It is a safe, fast, simple, non-invasive procedure and with a good correlation with more complex techniques. Studies have shown that electrical bioimpedance is a safe, reproducible and reliable method to assess body composition. The instrument to be used for research is the OMRON HBF-514® model. | Change from Baseline Electrical impedance at 2, 4 and at 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fitness, program training, exercise, health, physical condition, qualilty of Life, Functional capacity, physiological status, physical activity, elderly