ELDERLY PEOPLENCT04118478

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

A study testing multi-component phased training program in people with ELDERLY PEOPLE, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 to 80 yearsHealthy volunteers can take part
Conditions the study is for: ELDERLY PEOPLE
What is being tested?: multi-component phased training program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 siteSpain
Study dates: 15 Aug 2019to 20 Jul 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universidad Catolica de murcia
Murcia, 30109

Other trials in Spain

About this study

Official title: 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

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.

Read the 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).

Conditions: ELDERLY PEOPLE
Being tested: multi-component phased training program
Keywords: fitness, program training, exercise, health, physical condition, qualilty of Life, Functional capacity, physiological status, physical activity, elderly
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

multi-component phased training programBehavioural
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.

Study groups in NCT04118478
Study group	Role	What they receive
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 Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 201920 Jul 2020

First posted8 Oct 2019
Study start15 Aug 2019
Primary completion15 Feb 2020
Study completion20 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (30)Papers the sponsor has linked to this study.
Other trials for ELDERLY PEOPLEStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: A study protocol of a randomized controlled clinical trial with blinded examiners is presented.
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04118478
Sponsor's protocol ID: EJofre
Status last verified: Apr 2021
First submitted: 30 Sep 2019
Last updated: 27 Apr 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ball TJ, Joy EA, Gren LH, Shaw JM. Concurrent Validity of a Self-Reported Physical Activity "Vital Sign" Questionnaire With Adult Primary Care Patients. Prev Chronic Dis. 2016 Feb 4;13:E16. doi: 10.5888/pcd13.150228.
PubMed 26851335
Bouaziz W, Vogel T, Schmitt E, Kaltenbach G, Geny B, Lang PO. Health benefits of aerobic training programs in adults aged 70 and over: a systematic review. Arch Gerontol Geriatr. 2017 Mar-Apr;69:110-127. doi: 10.1016/j.archger.2016.10.012. Epub 2016 Oct 31.
PubMed 27912156
Cabrero-Garcia J, Munoz-Mendoza CL, Cabanero-Martinez MJ, Gonzalez-Llopis L, Ramos-Pichardo JD, Reig-Ferrer A. [Short physical performance battery reference values for patients 70 years-old and over in primary health care]. Aten Primaria. 2012 Sep;44(9):540-8. doi: 10.1016/j.aprim.2012.02.007. Epub 2012 May 16. Spanish.
PubMed 22608368
Cadore EL, Menger E, Teodoro JL, da Silva LXN, Boeno FP, Umpierre D, Botton CE, Ferrari R, Cunha GDS, Izquierdo M, Pinto RS. Functional and physiological adaptations following concurrent training using sets with and without concentric failure in elderly men: A randomized clinical trial. Exp Gerontol. 2018 Sep;110:182-190. doi: 10.1016/j.exger.2018.06.011. Epub 2018 Jun 13.
PubMed 29908345
Chan WC, Yeung JW, Wong CS, Lam LC, Chung KF, Luk JK, Lee JS, Law AC. Efficacy of physical exercise in preventing falls in older adults with cognitive impairment: a systematic review and meta-analysis. J Am Med Dir Assoc. 2015 Feb;16(2):149-54. doi: 10.1016/j.jamda.2014.08.007. Epub 2014 Oct 7.
PubMed 25304179
Coelho-Junior HJ, de Oliveira Goncalvez I, Sampaio RAC, Sewo Sampaio PY, Cadore EL, Izquierdo M, Marzetti E, Uchida MC. Periodized and non-periodized resistance training programs on body composition and physical function of older women. Exp Gerontol. 2019 Jul 1;121:10-18. doi: 10.1016/j.exger.2019.03.001. Epub 2019 Mar 9.
PubMed 30862526
Fragala MS, Cadore EL, Dorgo S, Izquierdo M, Kraemer WJ, Peterson MD, Ryan ED. Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning Association. J Strength Cond Res. 2019 Aug;33(8):2019-2052. doi: 10.1519/JSC.0000000000003230.
PubMed 31343601
Gomez-Morales A, Miranda JMA, Pergola-Marconato AM, Mansano-Schlosser TC, Mendes FRP, Torres GV. [The influence of activities on the quality of life of the elderly: a systematic review]. Cien Saude Colet. 2019 Jan;24(1):189-202. doi: 10.1590/1413-81232018241.05452017. Spanish.
PubMed 30698253
Guizelini PC, de Aguiar RA, Denadai BS, Caputo F, Greco CC. Effect of resistance training on muscle strength and rate of force development in healthy older adults: A systematic review and meta-analysis. Exp Gerontol. 2018 Feb;102:51-58. doi: 10.1016/j.exger.2017.11.020. Epub 2017 Nov 28.
PubMed 29196141
Izquierdo M. [Multicomponent physical exercise program: Vivifrail]. Nutr Hosp. 2019 Jul 1;36(Spec No2):50-56. doi: 10.20960/nh.02680. Spanish.
PubMed 31189323
Joseph RP, Keller C, Adams MA, Ainsworth BE. Validity of two brief physical activity questionnaires with accelerometers among African-American women. Prim Health Care Res Dev. 2016 May;17(3):265-76. doi: 10.1017/S1463423615000390. Epub 2015 Jul 16.
PubMed 26178779
Kim BS, Kim JH, Park SH, Seo HS, Lee HS, Lee MM. Effect of a Respiratory Training Program Using Wind Instruments on Cardiopulmonary Function, Endurance, and Quality of Life of Elderly Women. Med Sci Monit. 2018 Jul 29;24:5271-5278. doi: 10.12659/MSM.909492.
PubMed 30056459
Lu WC, Tzeng NS, Kao YC, Yeh CB, Kuo TB, Chang CC, Chang HA. Correlation between health-related quality of life in the physical domain and heart rate variability in asymptomatic adults. Health Qual Life Outcomes. 2016 Oct 21;14(1):149. doi: 10.1186/s12955-016-0555-y.
PubMed 27765048
Marcos-Pardo PJ, Orquin-Castrillon FJ, Gea-Garcia GM, Menayo-Antunez R, Gonzalez-Galvez N, Vale RGS, Martinez-Rodriguez A. Effects of a moderate-to-high intensity resistance circuit training on fat mass, functional capacity, muscular strength, and quality of life in elderly: A randomized controlled trial. Sci Rep. 2019 May 24;9(1):7830. doi: 10.1038/s41598-019-44329-6.
PubMed 31127163
Mendonca GV, Pezarat-Correia P, Vaz JR, Silva L, Almeida ID, Heffernan KS. Impact of Exercise Training on Physiological Measures of Physical Fitness in the Elderly. Curr Aging Sci. 2016;9(4):240-259. doi: 10.2174/1874609809666160426120600.
PubMed 27113585

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04118478
Acronym / sponsor ID: EJofre
Conditions: ELDERLY PEOPLE
Keywords: fitness, program training, exercise, health, physical condition, qualilty of Life, Functional capacity, physiological status
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Universidad Católica San Antonio de MurciaUniversity, hospital or other
Study start: 15 Aug 2019 (actual)
Primary completion: 15 Feb 2020 (actual)
Study completion: 20 Jul 2020 (actual)
First posted: 8 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2
Model description: A study protocol of a randomized controlled clinical trial with blinded examiners is presented.

Arm	Type	Receives
Multi-component phased training program	Experimental	Behavioral: multi-component phased training programThe 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
CONTROL	No intervention	–Older people assigned to the GC do not do any training programming. Only attend the measurement dates.

Who may qualify

Ages: 60 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
multi-component phased training programThe 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.	Behavioural	Multi-component phased training program

Primary outcome

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.
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, 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.
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.
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.
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.
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.
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.
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.
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
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
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.
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.

5 secondary outcomes

Motivation for the exercise
Time frame: Change from Baseline Motivation for the exercise at 6 month
"Physical Activity Vital Sign" (PAVS)
Time frame: Change from Baseline "Physical Activity Vital Sign" at 6 month
"Stanford Short Activity Survey"
Time frame: Change from Baseline "Stanford Short Activity Survey" at 6 month
Abdominal circumference
Time frame: Change from Baseline Abdominal circumference at 2, 4 and at 6 month
Electrical impedance
Time frame: Change from Baseline Electrical impedance at 2, 4 and at 6 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
Background: PubMed 26851335Ball TJ, Joy EA, Gren LH, Shaw JM. Concurrent Validity of a Self-Reported Physical Activity "Vital Sign" Questionnaire With Adult Primary Care Patients. Prev Chronic Dis. 2016 Feb 4;13:E16. doi: 10.5888/pcd13.150228.
Background: PubMed 27912156Bouaziz W, Vogel T, Schmitt E, Kaltenbach G, Geny B, Lang PO. Health benefits of aerobic training programs in adults aged 70 and over: a systematic review. Arch Gerontol Geriatr. 2017 Mar-Apr;69:110-127. doi: 10.1016/j.archger.2016.10.012. Epub 2016 Oct 31.
Background: PubMed 22608368Cabrero-Garcia J, Munoz-Mendoza CL, Cabanero-Martinez MJ, Gonzalez-Llopis L, Ramos-Pichardo JD, Reig-Ferrer A. [Short physical performance battery reference values for patients 70 years-old and over in primary health care]. Aten Primaria. 2012 Sep;44(9):540-8. doi: 10.1016/j.aprim.2012.02.007. Epub 2012 May 16. Spanish.
Background: PubMed 29908345Cadore EL, Menger E, Teodoro JL, da Silva LXN, Boeno FP, Umpierre D, Botton CE, Ferrari R, Cunha GDS, Izquierdo M, Pinto RS. Functional and physiological adaptations following concurrent training using sets with and without concentric failure in elderly men: A randomized clinical trial. Exp Gerontol. 2018 Sep;110:182-190. doi: 10.1016/j.exger.2018.06.011. Epub 2018 Jun 13.
Background: PubMed 25304179Chan WC, Yeung JW, Wong CS, Lam LC, Chung KF, Luk JK, Lee JS, Law AC. Efficacy of physical exercise in preventing falls in older adults with cognitive impairment: a systematic review and meta-analysis. J Am Med Dir Assoc. 2015 Feb;16(2):149-54. doi: 10.1016/j.jamda.2014.08.007. Epub 2014 Oct 7.
Background: PubMed 30862526Coelho-Junior HJ, de Oliveira Goncalvez I, Sampaio RAC, Sewo Sampaio PY, Cadore EL, Izquierdo M, Marzetti E, Uchida MC. Periodized and non-periodized resistance training programs on body composition and physical function of older women. Exp Gerontol. 2019 Jul 1;121:10-18. doi: 10.1016/j.exger.2019.03.001. Epub 2019 Mar 9.
Background: PubMed 31343601Fragala MS, Cadore EL, Dorgo S, Izquierdo M, Kraemer WJ, Peterson MD, Ryan ED. Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning Association. J Strength Cond Res. 2019 Aug;33(8):2019-2052. doi: 10.1519/JSC.0000000000003230.
Background: PubMed 30698253Gomez-Morales A, Miranda JMA, Pergola-Marconato AM, Mansano-Schlosser TC, Mendes FRP, Torres GV. [The influence of activities on the quality of life of the elderly: a systematic review]. Cien Saude Colet. 2019 Jan;24(1):189-202. doi: 10.1590/1413-81232018241.05452017. Spanish.
Background: PubMed 29196141Guizelini PC, de Aguiar RA, Denadai BS, Caputo F, Greco CC. Effect of resistance training on muscle strength and rate of force development in healthy older adults: A systematic review and meta-analysis. Exp Gerontol. 2018 Feb;102:51-58. doi: 10.1016/j.exger.2017.11.020. Epub 2017 Nov 28.
Background: PubMed 31189323Izquierdo M. [Multicomponent physical exercise program: Vivifrail]. Nutr Hosp. 2019 Jul 1;36(Spec No2):50-56. doi: 10.20960/nh.02680. Spanish.
Background: PubMed 26178779Joseph RP, Keller C, Adams MA, Ainsworth BE. Validity of two brief physical activity questionnaires with accelerometers among African-American women. Prim Health Care Res Dev. 2016 May;17(3):265-76. doi: 10.1017/S1463423615000390. Epub 2015 Jul 16.
Background: PubMed 30056459Kim BS, Kim JH, Park SH, Seo HS, Lee HS, Lee MM. Effect of a Respiratory Training Program Using Wind Instruments on Cardiopulmonary Function, Endurance, and Quality of Life of Elderly Women. Med Sci Monit. 2018 Jul 29;24:5271-5278. doi: 10.12659/MSM.909492.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emilio Jofré-Saldía, MSc principal investigator

UCAM

Gemma García, Phd study director

UCAM

Alvaro Villalobos, Msc principal investigator

University of Ibadan Teaching Hospital (UCH)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing multi-component phased training program in people with ELDERLY PEOPLE, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of the quality of life (time frame: Change from Baseline quality life at 2, 4 and at 6 month). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04118478, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.