Skip to main content
Clinical Trials/NCT04118478
NCT04118478
Completed
Not Applicable

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

Universidad Católica San Antonio de Murcia1 site in 1 country102 target enrollmentAugust 15, 2019
ConditionsELDERLY PEOPLE

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ELDERLY PEOPLE
Sponsor
Universidad Católica San Antonio de Murcia
Enrollment
102
Locations
1
Primary Endpoint
Time Up and Go
Status
Completed
Last Updated
5 years ago

Overview

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.

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
August 15, 2019
End Date
July 20, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidad Católica San Antonio de Murcia
Responsible Party
Principal Investigator
Principal Investigator

Emilio Eduardo Jofre Saldia

Principal Investigator

Universidad Católica San Antonio de Murcia

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Time Up and Go

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

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.

Assessment of the quality of life

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

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.

Spirometry, forced expiratory volume in one second (FEV1)

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

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.

Resting Heart rate

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

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.

Sit and reach test

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

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.

Two minutes "Step test"

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

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

Back scratch test

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

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.

Resting blood pressure

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

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.

Dynamometry

Time Frame: Change from Baseline Dynamometry at 2, 4 and at 6 month

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.

Heart rate variability

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

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

Spirometry, peak expiratory flow (PEF)

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

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.

Short Physical Performance Battery (SPPB)

Time Frame: Change from Baseline SPPB at 2, 4 and at 6 month

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.

Walking speed in 4 and 6 meters

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

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.

Walking While Talking (WWT)

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

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

Secondary Outcomes

  • "Stanford Short Activity Survey"(Change from Baseline "Stanford Short Activity Survey" at 6 month)
  • 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)
  • 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 Sites (1)

Loading locations...

Similar Trials