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

ELDERLY PEOPLE Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118478
• Other study ID #: EJofre
• Status: Completed
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: July 20, 2020

Study information

• Verified date: April 2021
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 20, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• ELDERLY PEOPLE

Intervention

Behavioral:
• multi-component phased training program
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.

Locations

Country	Name	City	State
Spain	Universidad Catolica de murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

References & Publications (29)

Ball TJ, Joy EA, Goh TL, Hannon JC, Gren LH, Shaw JM. Validity of two brief primary care physical activity questionnaires with accelerometry in clinic staff. Prim Health Care Res Dev. 2015 Jan;16(1):100-8. doi: 10.1017/S1463423613000479. Epub 2014 Jan 28. — View Citation

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. Erratum in: Prev Chronic Dis. 2016;13:E30. — View Citation

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. Review. — View Citation

Cabrero-García J, Muñoz-Mendoza CL, Cabañero-Martínez MJ, González-Llopís 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. — View Citation

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. — View Citation

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. Review. — View Citation

Coelho-Júnior HJ, de Oliveira Gonçalvez 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. — View Citation

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. Review. — View Citation

Gómez-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. — View Citation

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. — View Citation

Izquierdo M. [Multicomponent physical exercise program: Vivifrail]. Nutr Hosp. 2019 Jul 1;36(Spec No2):50-56. doi: 10.20960/nh.02680. Review. Spanish. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Marcos-Pardo PJ, Orquin-Castrillón FJ, Gea-García GM, Menayo-Antúnez R, González-Gálvez N, Vale RGS, Martínez-Rodríguez 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. — View Citation

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. Review. — View Citation

Millor N, Lecumberri P, Gomez M, Martinez A, Martinikorena J, Rodriguez-Manas L, Garcia-Garcia FJ, Izquierdo M. Gait Velocity and Chair Sit-Stand-Sit Performance Improves Current Frailty-Status Identification. IEEE Trans Neural Syst Rehabil Eng. 2017 Nov;25(11):2018-2025. doi: 10.1109/TNSRE.2017.2699124. Epub 2017 Apr 27. — View Citation

Perez-Sousa MA, Venegas-Sanabria LC, Chavarro-Carvajal DA, Cano-Gutierrez CA, Izquierdo M, Correa-Bautista JE, Ramírez-Vélez R. Gait speed as a mediator of the effect of sarcopenia on dependency in activities of daily living. J Cachexia Sarcopenia Muscle. 2019 Oct;10(5):1009-1015. doi: 10.1002/jcsm.12444. Epub 2019 May 8. — View Citation

Raffin J, Barthélémy JC, Dupré C, Pichot V, Berger M, Féasson L, Busso T, Da Costa A, Colvez A, Montuy-Coquard C, Bouvier R, Bongue B, Roche F, Hupin D. Exercise Frequency Determines Heart Rate Variability Gains in Older People: A Meta-Analysis and Meta-Regression. Sports Med. 2019 May;49(5):719-729. doi: 10.1007/s40279-019-01097-7. — View Citation

Ramirez-Campillo R, Alvarez C, García-Hermoso A, Celis-Morales C, Ramirez-Velez R, Gentil P, Izquierdo M. Reply to the commentary on: High-speed resistance training in elderly women: Effects of cluster training sets on functional performance and quality of life. Exp Gerontol. 2019 Aug;123:34-35. doi: 10.1016/j.exger.2019.05.012. Epub 2019 May 25. — View Citation

Ramírez-Vélez R, Correa-Bautista JE, García-Hermoso A, Cano CA, Izquierdo M. Reference values for handgrip strength and their association with intrinsic capacity domains among older adults. J Cachexia Sarcopenia Muscle. 2019 Apr;10(2):278-286. doi: 10.1002/jcsm.12373. Epub 2019 Mar 6. — View Citation

Ramírez-Vélez R, Izquierdo M. Editorial: Precision Physical Activity and Exercise Prescriptions for Disease Prevention: The Effect of Interindividual Variability Under Different Training Approaches. Front Physiol. 2019 May 24;10:646. doi: 10.3389/fphys.2019.00646. eCollection 2019. — View Citation

Rodriguez-Mañas L, Laosa O, Vellas B, Paolisso G, Topinkova E, Oliva-Moreno J, Bourdel-Marchasson I, Izquierdo M, Hood K, Zeyfang A, Gambassi G, Petrovic M, Hardman TC, Kelson MJ, Bautmans I, Abellan G, Barbieri M, Peña-Longobardo LM, Regueme SC, Calvani R, De Buyser S, Sinclair AJ; European MID-Frail Consortium. Effectiveness of a multimodal intervention in functionally impaired older people with type 2 diabetes mellitus. J Cachexia Sarcopenia Muscle. 2019 Aug;10(4):721-733. doi: 10.1002/jcsm.12432. Epub 2019 Apr 23. — View Citation

Sáez de Asteasu ML, Martínez-Velilla N, Zambom-Ferraresi F, Casas-Herrero Á, Izquierdo M. Role of physical exercise on cognitive function in healthy older adults: A systematic review of randomized clinical trials. Ageing Res Rev. 2017 Aug;37:117-134. doi: 10.1016/j.arr.2017.05.007. Epub 2017 Jun 3. Review. — View Citation

Sáez de Asteasu ML, Martínez-Velilla N, Zambom-Ferraresi F, Casas-Herrero Á, Ramirez-Vélez R, Izquierdo M. Role of muscle power output as a mediator between gait variability and gait velocity in hospitalized older adults. Exp Gerontol. 2019 Sep;124:110631. doi: 10.1016/j.exger.2019.110631. Epub 2019 Jun 12. — View Citation

Tan JPH, Beilharz JE, Vollmer-Conna U, Cvejic E. Heart rate variability as a marker of healthy ageing. Int J Cardiol. 2019 Jan 15;275:101-103. doi: 10.1016/j.ijcard.2018.08.005. Epub 2018 Aug 3. — View Citation

Taylor-Piliae RE, Fair JM, Haskell WL, Varady AN, Iribarren C, Hlatky MA, Go AS, Fortmann SP. Validation of the Stanford Brief Activity Survey: examining psychological factors and physical activity levels in older adults. J Phys Act Health. 2010 Jan;7(1):87-94. — View Citation

Teodoro JL, da Silva LXN, Fritsch CG, Baroni BM, Grazioli R, Boeno FP, Lopez P, Gentil P, Bottaro M, Pinto RS, Izquierdo M, Cadore EL. Concurrent training performed with and without repetitions to failure in older men: A randomized clinical trial. Scand J Med Sci Sports. 2019 Aug;29(8):1141-1152. doi: 10.1111/sms.13451. Epub 2019 May 22. — View Citation

Vilagut G, Ferrer M, Rajmil L, Rebollo P, Permanyer-Miralda G, Quintana JM, Santed R, Valderas JM, Ribera A, Domingo-Salvany A, Alonso J. [The Spanish version of the Short Form 36 Health Survey: a decade of experience and new developments]. Gac Sanit. 2005 Mar-Apr;19(2):135-50. Review. Spanish. — View Citation

* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	"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
Secondary	"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
Secondary	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
Secondary	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